The Orthotic Effects of Different Functional Electrical Stimulation Protocols on Walking Performance in Individuals with Incomplete Spinal Cord Injury: A Case Series.

Background: Functional electrical stimulation (FES) of paralyzed muscles can facilitate walking after spinal cord injury (SCI). Objectives: To test the orthotic effects of different FES walking protocols on lower joint kinematics and walking speed. Methods: Three adults with incomplete SCI participated in this study. Their lower extremity motor scores and 10-meter walk test results were as follows: subject A: 50, 1.05 m/s, subject B: 44, 0.29 m/s, and subject C: 32, 0.27 m/s. Participants completed four conditions of over-ground walking including no FES and three bilateral FES-walking protocols as follows: multi-muscle stimulation (stimulation of quadriceps and gastrocnemius in the stance phase, and hamstring and tibialis anterior in the swing phase), drop foot (tibialis anterior stimulation), and flexor withdrawal (common peroneal nerve stimulation). The FES system obtained gait phase information from foot switches located under the individuals' heels. Three-dimensional kinematic analysis was undertaken to measure minimum toe clearance (MTC); ankle, knee, and hip range of motion (ROM); stride length; and stride speed. Results: Compared to no-FES walking, MTC increased during drop foot (all subjects), flexor withdrawal (subjects A and B), and multi-muscle stimulation (subjects B and C) protocols. A significant decrease in ankle ROM was seen with drop foot (all subjects), flexor withdrawal (subjects A), and multi-muscle stimulation (subjects A and C) protocols. Hip ROM increased with drop foot (subjects B and C), flexor withdrawal (subject B), and multi-muscle stimulation (subject C) protocols. Conclusion: Three FES walking protocols induced positive kinematic changes as indicated by increased MTC, decreased ankle ROM, and increased hip ROM during walking in subjects with incomplete SCI.

Feasibility and significance of stimulating interscapular muscles using transcutaneous functional electrical stimulation in able-bodied individuals.

OBJECTIVE: The study objective was to assess the feasibility of stimulating the lower trapezius (LT), the upper trapezius (UT) and serratus anterior (SA) muscles along with anterior or middle deltoid, using surface functional electrical stimulation (FES). The secondary aim was to understand the effects of LT, UT, and SA stimulation on maximum arm reach achieved in shoulder flexion and abduction. DESIGN: Single arm interventional study. SETTING: Inpatient Rehabilitation Hospital. PARTICIPANTS: Ten healthy volunteers. INTERVENTION: Participants completed 10 trials for each of the 3 conditions in flexion and abduction, i.e. (1) Active voluntary flexion or abduction, (2) FES for anterior deltoid for flexion or middle deltoid for abduction, and (3) FES for LT, UT, and SA along with anterior deltoid for flexion or middle deltoid for abduction. OUTCOME MEASURES: Maximum arm reach and percent angle relative to the voluntary movement were computed from motion capture data for each condition. Wilcoxon signed-rank test was used to compare the maximum reach between two FES conditions. RESULTS: The study results showed that all three interscapular muscles can be stimulated using surface FES. Maximum reach in abduction was greater for FES of middle deltoid along with the interscapular muscles (51.77° ± 17.54°) compared to FES for middle deltoid alone (43.76° ± 15.32°; Z = -2.701, P = 0.007). Maximum reach in flexion for FES of anterior deltoid, along with interscapular muscles, was similar to that during FES of anterior deltoid alone. CONCLUSION: Interscapular muscles can be stimulated using surface FES devices and should be engaged during rehabilitation as appropriate.

Preliminary evaluation of the reliability and validity of the 3D printed Toronto Rehabilitation Institute-Hand Function Test in individuals with spinal cord injury.

OBJECTIVE: The study objectives were to evaluate the inter-rater and intra-rater reliability; and criterion and construct validity of the 3D printed Toronto Rehabilitation Institute -Hand Function Test (3D TRI-HFT) in individuals with spinal cord injury (SCI). DESIGN: Observational study. SETTING: Inpatient Rehabilitation Hospital. PARTICIPANTS: Four individuals with subacute and three individuals with chronic SCI. INTERVENTIONS: Reliability and validity of the 3D TRI-HFT was assessed within two interventional studies. OUTCOME MEASURES: Participants performed the 3D TRI-HFT, Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), Functional Independence Measure (FIM) and the Spinal Cord Independence Measure (SCIM) at baseline, after 20 and 40 sessions of therapy and at six month follow-up from baseline. 3D TRI-HFT assessments were graded at the time of performance and re-graded from the video recordings for purpose of reliability testing. Validity testing was done by comparing the scores on 3D TRI-HFT with the scores on the GRASSP, and the FIM and SCIM self care sub-scores. RESULTS: The 3D TRI-HFT had high intra-rater and inter-rater reliability in sub-acute and chronic SCI with ICC values exceeding 0.99. Moderate to strong correlations were found between 3D TRI-HFT object manipulation scores and the FIM and SCIM self care sub-scores, with r values in the range of 0.7-0.8. Strong correlations were found between the various components of GRASSP and the 3D TRI-HFT, with r values exceeding 0.9. CONCLUSIONS: The 3D TRI-HFT is a reliable and valid measure to assess unilateral hand gross motor function in individuals with SCI.

Development of Reaching, Grasping & Manipulation indicators to advance the quality of spinal cord injury rehabilitation: SCI-High Project.

OBJECTIVE: To describe the development of structure, process, and outcome indicators aimed to advance the quality of Reaching, Grasping & Manipulation (RG&M) rehabilitation for Canadians living with spinal cord injury or disease (SCI/D). METHOD: Upper extremity rehabilitation experts developed a framework of indicators for evaluation of RG&M rehabilitation quality. A systematic search of the literature identified potential upper extremity indicators that influence RG&M outcomes. A Driver diagram summarized factors influencing upper extremity outcomes to inform the selection of structure and process indicators. Psychometric properties, clinical utility, and feasibility of potential upper extremity measures were considered when selecting outcome indicators. RESULTS: The selected structure indicator is the number of occupational and physical therapists with specialized certification, education, training and/or work experience in upper extremity therapy related to RG&M at a given SCI/D rehabilitation center. The process indicator is the total hours of upper extremity therapies related to RG&M and the proportion of this time allocated to neurorestorative therapy for each individual with tetraplegia receiving therapy. The outcome indicators are the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) strength and Spinal Cord Independence Measure III (SCIM III) Self-Care subscores implemented at rehabilitation admission and discharge, and SCIM III Self-Care subscore only at 18 months post-admission. CONCLUSION: The selected indicators align with current practice, will direct the timing of routine assessments, and enhance the volume and quality of RG&M therapy delivered, with the aim to ultimately increase the proportion of individuals with tetraplegia achieving improved upper extremity function by 18 months post-rehabilitation.

Brain-computer interface-triggered functional electrical stimulation therapy for rehabilitation of reaching and grasping after spinal cord injury: a feasibility study.

STUDY DESIGN: Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. OBJECTIVES: We developed a brain-computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI). SETTING: Spinal cord injury rehabilitation hospital-Toronto Rehabilitation Institute-Lyndhurst Centre. METHODS: Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants' compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes. RESULTS: On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID. CONCLUSIONS: The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.

3-Dimensional printing in rehabilitation: feasibility of printing an upper extremity gross motor function assessment tool.

BACKGROUND: Use of standardized and scientifically sound outcome measures is encouraged in clinical practice and research. With the development of newer rehabilitation therapies, we need technology-supported upper extremity outcome measures that are easily accessible, reliable and valid. 3-Dimensional printing (3D-printing) has recently seen a meteoric rise in interest within medicine including the field of Physical Medicine and Rehabilitation. The primary objective of this study was to evaluate the feasibility of designing and constructing a 3D printed version of the Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT). The TRI-HFT is an upper extremity gross motor function assessment tool that measures function at the intersection of the International Classification of Function's body structure and function, and activity domain. The secondary objective was to assess the preliminary psychometrics of this test in individuals with stroke. RESULTS: 3D design files were created using the measurements of the original TRI-HFT objects. The 3D printed objects were then compared to the original test objects to ensure that the original dimensions were preserved. All objects were successfully printed except the sponge and paper which required some modification. The error margin for weight of the objects was within 10% of the original TRI-HFT for the rest of the objects. Nine participants underwent the following assessments: the Chedoke Arm and Hand Activity Inventory (CAHAI), Fugl Meyer Assessment-Hand (FMA-Hand), Chedoke McMaster stages of recovery of the arm (CMSA-Arm) and Chedoke McMaster stages of recovery of the hand (CMSA-Hand) and the 3D TRI-HFT for assessment of psychometric properties of the test. The video recorded assessment of the 3D TRI-HFT was used for reliability testing. Construct validity was assessed by comparing the scores on 3D TRI-HFT with the scores on CAHAI, CMSA-Arm, CMSA-Hand and FMA-Hand. The 3D TRI-HFT had high inter-rater reliability (Intra-Class Correlation Co-efficient (ICC) of 0.99; P < 0.000), high intra-rater reliability (ICC of 0.99; P < 0.000) and moderate-to-strong correlation with the CMSA-Arm, CMSA-Hand and FMA-Hand scores. CONCLUSIONS: The TRI-HFT could be successfully 3D printed and initial testing indicates that the test is a reliable and valid measure of upper extremity motor function in individuals with stroke.

Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study.

INTRODUCTION: This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres. METHODS AND ANALYSIS: Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. ETHICS AND DISSEMINATION: All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319.

Functional Electrical Stimulation Therapy for Retraining Reaching and Grasping After Spinal Cord Injury and Stroke.

Neurological conditions like hemiplegia following stroke or tetraplegia following spinal cord injury, result in a massive compromise in motor function. Each of the two conditions can leave individuals dependent on caregivers for the rest of their lives. Once medically stable, rehabilitation is the main stay of treatment. This article will address rehabilitation of upper extremity function. It is long known that moving the affected limb is crucial to recovery following any kind of injury. Overtime, it has also been established that just moving the affected extremities does not suffice, and that the movements have to involve patient's participation, be as close to physiologic movements as possible, and should ideally stimulate the entire neuromuscular circuitry involved in producing the desired movement. For over four decades now, functional electrical stimulation (FES) is being used to either replace or retrain function. The FES therapy discussed in this article has been used to retrain upper extremity function for over 15 years. Published data of pilot studies and randomized control trials show that FES therapy produces significant changes in arm and hand function. There are specific principles of the FES therapy as applied in our studies: (i) stimulation is applied using surface stimulation electrodes, (ii) there is minimum to virtually no pain during application, (iii) each session lasts no more than 45-60 min, (iv) the technology is quite robust and can make up for specificity to a certain extent, and (v) fine motor function like two finger precision grip can be trained (i.e., thumb and index finger tip to tip pinch). The FES therapy protocols can be successfully applied to individuals with paralysis resulting from stroke or spinal cord injury.

Restoration of Upper Limb Function After Chronic Severe Hemiplegia: A Case Report on the Feasibility of a Brain-Computer Interface-Triggered Functional Electrical Stimulation Therapy.

Functional electrical stimulation therapy (FEST) is a state-of-the-art treatment for retraining motor function after neurological injuries. Recent literature suggests that FEST can be further improved with brain-computer interface (BCI) technology. In this case study, we assessed the feasibility of using BCI-triggered FEST (BCI-FEST) to restore upper limb function in a 57-yr-old man with severe left hemiplegia resulting from a stroke 6 yrs before enrollment in the study. The intervention consisted of two blocks of forty 1-hr BCI-FEST sessions, with three sessions delivered weekly. During therapy, a single-channel BCI was used to trigger the stimulation programmed to facilitate functional movements. The measure of the feasibility of the BCI-FEST included assessing the implementation and safety of the intervention. Clinical improvements were assessed using (a) Functional Independence Measure, (b) Action Research Arm Test, (c) Toronto Rehabilitation Institute - Hand Function Test, and (d) Fugl-Meyer Assessment Upper Extremity test. Upon completion of 80 therapy sessions, 14-, 17-, and 18-point changes were recorded on Action Research Arm Test, Fugl-Meyer Assessment Upper Extremity test, and Toronto Rehabilitation Institute - Hand Function Test, respectively. The participant also indicated improvement as demonstrated by his ability to perform various day-to-day tasks. The results suggest that BCI-FEST is safe and viable.

Functional electrical stimulation of the facial muscles to improve symptoms in individuals with major depressive disorder: pilot feasibility study.

BACKGROUND: Currently, the mainstay of treatment in patients diagnosed with major depressive disorder (MDD) requiring medical attention is second generation anti-depressants. However, about 40% of patients treated with second-generation anti-depressants do not respond to initial treatment and approximately 70% do not achieve remission during the first-step treatment. There are a few non-pharmacological options available, but none have shown consistently positive results. There is a need for an intervention that is relatively easy to administer, produces consistently positive results and is associated with minimal side effects. In the current study, we assessed the feasibility of using transcutaneous Functional Electrical Stimulation Therapy (FEST) of the facial muscles, as a tool for improving depressive symptoms in individuals with MDD. RESULTS: Ten (10) individuals with moderate to severe MDD received three FEST sessions/week for a minimum of 10 to a maximum of 40 sessions. All study participants completed the required 10 therapy sessions, and 5 of the 10 participants completed additional 30 (totalling 40) FEST sessions. There were no adverse events or concerns regarding compliance to therapy. We found statistically significant improvements on Hamilton Rating Scale for Depression (HDS) and Inventory of Depressive Symptomatology (IDS) measures. However, no significant improvements were found on Positive and Negative Affect Scale and 10-point Visual Analogue Scale scales. Participants reported improvements in sleeping patterns, and this correlated with statistically significant improvements on sleep parameters of HDS and IDS measures. CONCLUSION: This study indicates that facial FEST is an acceptable, practical, and safe treatment in individuals with MDD. We provide preliminary evidence to show improvements in depressive symptoms following a minimum of 10 FEST sessions.

Lessons learned from the pilot study of an orthostatic hypotension intervention in the subacute phase following spinal cord injury.

Context: Following spinal cord injury (SCI) at the cervical or upper-thoracic level, orthostatic hypotension (OH) is observed in 13-100% of patients. This study aimed to test the feasibility of conducting a randomized controlled trial combining a dynamic tilt-table (Erigo®) and functional electrical stimulation (FES) to mitigate OH symptoms in the subacute phase after SCI. Design: Pilot study. Setting: A tertiary rehabilitation hospital. Participants: Inpatients who had a C4-T6 SCI (AIS A-D) less than 12 weeks before recruitment, and reported symptoms of OH in their medical chart. Interventions: Screening sit-up test to determine eligibility, then 1 assessment session and 3 intervention sessions with Erigo® and FES for eligible participants. Outcome measures: Recruitment rate, duration of assessment and interventions, resources used, blood pressure, and Calgary Presyncope Form (OH symptoms). Results: Amongst the 232 admissions, 148 inpatient charts were reviewed, 11 inpatients met all inclusion criteria, 7 participated in a screening sit-up test, and 2 exhibited OH. Neither of the two participants recruited in the pilot study was able to fully complete the assessment and intervention sessions due to scheduling issues (i.e. limited available time). Conclusion: This pilot study evidenced the non-feasibility of the clinical trial as originally designed, due to the low recruitment rate and the lack of available time for research in participant's weekday schedule. OH in the subacute phase after SCI was less prevalent and less incapacitating than expected. Conventional management and spontaneous resolution of symptoms appeared sufficient to mitigate OH in most patients with subacute SCI.

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency.

BACKGROUND: Multi-channel surface functional electrical stimulation (FES) for walking has been used to improve voluntary walking and balance in individuals with spinal cord injury (SCI). OBJECTIVE: To investigate short- and long-term benefits of 16 weeks of thrice-weekly FES-assisted walking program, while ambulating on a body weight support treadmill and harness system, versus a non-FES exercise program, on improvements in gait and balance in individuals with chronic incomplete traumatic SCI, in a randomized controlled trial design. METHODS: Individuals with traumatic and chronic (≥18 months) motor incomplete SCI (level C2 to T12, American Spinal Cord Injury Association Impairment Scale C or D) were recruited from an outpatient SCI rehabilitation hospital, and randomized to FES-assisted walking therapy (intervention group) or aerobic and resistance training program (control group). Outcomes were assessed at baseline, and after 4, 6, and 12 months. Gait, balance, spasticity, and functional measures were collected. RESULTS: Spinal cord independence measure (SCIM) mobility sub-score improved over time in the intervention group compared with the control group (baseline/12 months: 17.27/21.33 vs. 19.09/17.36, respectively). On all other outcome measures the intervention and control groups had similar improvements. Irrespective of group allocation walking speed, endurance, and balance during ambulation all improved upon completion of therapy, and majority of participants retained these gains at long-term follow-ups. CONCLUSIONS: Task-oriented training improves walking ability in individuals with incomplete SCI, even in the chronic stage. Further randomized controlled trials, involving a large number of participants are needed, to verify if FES-assisted treadmill training is superior to aerobic and strength training.

Influence of different rehabilitation therapy models on patient outcomes: hand function therapy in individuals with incomplete SCI.

OBJECTIVES: The primary objective was to compare the benefits of single (COT1) versus double (COT2) dose of conventional occupational therapy (COT) in improving voluntary hand function in individuals with incomplete, sub-acute C3-C7 spinal cord injury (SCI). The secondary objective was to compare these two interventions versus functional electrical stimulation therapy plus COT (FES + COT). DESIGN: Retrospective analysis. Setting Inpatient spinal cord rehabilitation center, Toronto. PARTICIPANTS: Individuals with traumatic incomplete sub-acute SCI. INTERVENTIONS: Data from Phases I and II (ClinicalTrials.gov ID NCT00221117) randomized control trials were pooled together for the purpose of this study. Participants in the COT1 group received 45 hours of therapy, the COT2 group received 80 hours of therapy, and the FES + COT group received 40 hours of COT therapy +40 hours of FES therapy. OUTCOME MEASURES: We analyzed the functional independence measure (FIM) and the spinal cord independence measure (SCIM) self-care sub-scores. Results The mean change scores on the FIM self-care sub-score for the COT1, COT2, and FES + COT groups were 12.8, 10, and 20.1 points, respectively. Similarly, the mean change scores on the SCIM self-care sub-score for the COT1, COT2, and FES + COT groups were, 2.6, 3.16, and 10.2 points, respectively. CONCLUSION: Increased rehabilitation intensity alone may not always be beneficial. The type of intervention plays a significant role in determining functional changes. In this instance, receiving one (COT1) or two (COT2) doses of COT resulted in similar outcomes, however, FES + COT therapy yielded much better outcomes compared to COT1 and COT2 interventions.

Functional electrical stimulation therapy for recovery of reaching and grasping in severe chronic pediatric stroke patients.

Stroke affects 2.7 children per 100,000 annually, leaving many of them with lifelong residual impairments despite intensive rehabilitation. In the present study the authors evaluated the effectiveness of 48 hours of transcutaneous functional electrical stimulation therapy for retraining voluntary reaching and grasping in 4 severe chronic pediatric stroke participants. Participants were assessed using the Rehabilitation Engineering Laboratory Hand Function Test, Quality of Upper Extremity Skills Test, Pediatric Evaluation of Disability Inventory, and Assisting Hand Assessment. All participants improved on all measures. The average change scores on selected Rehabilitation Engineering Laboratory Hand Function Test components were 14.5 for object manipulation (P = .042), 0.78 Nm for instrumented cylinder (P = .068), and 14 for wooden blocks (P = .068) and on the grasp component of Quality of Upper Extremity Skills Test was 25.93 (P = .068). These results provide preliminary evidence that functional electrical stimulation therapy has the potential to improve upper limb function in severe chronic pediatric stroke patients.

Randomized trial of functional electrical stimulation therapy for walking in incomplete spinal cord injury: effects on quality of life and community participation.

BACKGROUND: Functional electrical stimulation (FES) therapy has been applied to achieve functional benefits post spinal cord injury (SCI), but little is known about its effects on well-being. OBJECTIVE: Using a parallel-group randomized controlled trial (RCT) design (NCT00201968), the effects of a FES-assisted walking intervention on quality of life and participation post SCI were compared to a non-FES exercise program. METHODS: Individuals with chronic (≥18 months) incomplete SCI (level C2 to T12, AIS C or D) were randomized to a FES-assisted walking (intervention) or aerobic/resistance training (control) sessions 3 times a week for 16 weeks. The Spinal Cord Independence Measure (SCIM), Satisfaction With Life Scale, Lawton Instrumental Activities of Daily Living, Craig Handicap and Assessment Reporting Technique, Reintegration to Normal Living Index, and perceptions of intervention(s) outcomes were completed at baseline, 4, 6, and 12 months. Repeated measures general linear models were used to assess between-group differences. Perceptions of intervention(s) were analyzed using qualitative content analysis. RESULTS: Thirty-four individuals were randomized (17 per group); 27 remained at 12 months. The FES group had a significant increase (P < .01) on SCIM mobility subscores (mean [SD] = 17.27 [7.2] to 21.33 [7.6]) compared to the exercise group (mean [SD] = 19.9 [17.1] to 17.36 [5.5]). Although no significant between-group differences were detected for other outcomes, both groups reported positive gains in well-being from trial participation. CONCLUSIONS: The present study provides insight into the perceived benefits acquired by participating in an RCT comparing exercise to FES therapy and serves as a model for pinpointing domains of well-being that could be targeted for assessment in future SCI trials.

Restoring voluntary grasping function in individuals with incomplete chronic spinal cord injury: pilot study.

BACKGROUND: Functional electrical stimulation (FES) therapy has been shown to be one of the most promising approaches for improving voluntary grasping function in individuals with subacute cervical spinal cord injury (SCI). OBJECTIVE: To determine the effectiveness of FES therapy, as compared to conventional occupational therapy (COT), in improving voluntary hand function in individuals with chronic (≥24 months post injury), incomplete (American Spinal Injury Association Impairment Scale [AIS] B-D), C4 to C7 SCI. METHODS: Eight participants were randomized to the intervention group (FES therapy; n = 5) or the control group (COT; n = 3). Both groups received 39 hours of therapy over 13 to 16 weeks. The primary outcome measure was the Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT), and the secondary outcome measures were Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP), Functional Independence Measure (FIM) self-care subscore, and Spinal Cord Independence Measure (SCIM) self-care subscore. Outcome assessments were performed at baseline, after 39 sessions of therapy, and at 6 months following the baseline assessment. RESULTS: After 39 sessions of therapy, the intervention group improved by 5.8 points on the TRI-HFT's Object Manipulation Task, whereas the control group changed by only 1.17 points. Similarly, after 39 sessions of therapy, the intervention group improved by 4.6 points on the FIM self-care subscore, whereas the control group did not change at all. CONCLUSION: The results of the pilot data justify a clinical trial to compare FES therapy and COT alone to improve voluntary hand function in individuals with chronic incomplete tetraplegia.

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition.

OBJECTIVE: To evaluate the effects of functional electrical stimulation (FES)-assisted walking on body composition, compared to a non-FES exercise program in individuals with a spinal cord injury (SCI). DESIGN: Parallel-group randomized controlled trial. METHODS: Individuals with chronic (≥ 18 months) incomplete SCI (level C2 to T12, AIS C or D) were recruited and randomized to FES-assisted walking (intervention), or aerobic and resistance training (control) sessions thrice-weekly for 16 weeks. Whole body and leg lean mass and whole body fat mass, measured with dual-energy X-ray absorptiometry, and lower-limb muscle cross-sectional area (CSA) and fat CSA, measured with peripheral computed tomography were assessed at baseline, 4 months, and 12 months. Intention-to-treat analyses using repeated measures general linear models were used to assess between-group differences. RESULTS: Thirty-four individuals were randomized (17 per group); 27 remained at 12 months. There were no significant main effects of FES-assisted walking on body composition variables in intention-to-treat analyses with group means. There was a significant group-by-time interaction for muscle area from baseline to 12 months (P = 0.04). Intention-to-treat analysis of muscle area change scores between baseline and 12 months revealed a significant difference between groups (mean (SD) muscle area change score 212 (517) mm(s) for FES, -136 (268) mm(s) for control, P = 0.026). There were 13 side effects or adverse events deemed related to study participation (7 intervention, 5 control); most were resolved with modifications to the protocol. One fainting episode resulted in a hospital visit and study withdrawal. CONCLUSIONS: Thrice-weekly FES-assisted walking exercise over 4 months did not result in a change in body composition in individuals with chronic, motor incomplete C2 to T12 SCI (AIS classification C and D). However, longer-term follow-up revealed that it might maintain muscle area.

Toronto rehabilitation institute-hand function test: assessment of gross motor function in individuals with spinal cord injury.

PURPOSE: The objective of this study was to evaluate the interrater reliability, construct validity, and sensitivity of Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT), within an interventional randomized control trial. METHOD: Twenty-one participants with subacute C4 to C7 spinal cord injury (SCI) were recruited. Based on randomization, participants were allocated to either the functional electrical stimulation therapy group or the conventional occupational therapy group. Baseline and follow-up assessments of participants were videotaped. For testing interrater reliability, videotaped images were transferred to DVDs that were later observed by 2 observers. Construct validity was determined by comparing total scores on TRI-HFT to self-care subscore components of the Spinal Cord Independence Measure (SCIM) and FIM. To establish sensitivity of TRI-HFT, we compared pre- and posttreatment scores on all 3 measures (ie, TRI-HFT, FIM, and SCIM). RESULTS: TRI-HFT was found to have high interrater reliability with an intercorrelation coefficient (ICC) of 0.98. Moderate to strong correlations were found between TRI-HFT total scores and self-care components of FIM and SCIM for both hands individually post therapy. Due to a floor effect of the FIM and SCIM, there was weak correlation between pretherapy scores of the said measures and TRI-HFT. TRI-HFT was found to be highly sensitive in determining difference in function pre and post therapy. CONCLUSIONS: This study demonstrated that the TRI-HFT is a reliable and sensitive measure to assess unilateral hand gross motor function in persons with tetraplegia, with moderate to strong construct validity.

Relationship between clinical assessments of function and measurements from an upper-limb robotic rehabilitation device in cervical spinal cord injury.

Upper limb robotic rehabilitation devices can collect quantitative data about the user's movements. Identifying relationships between robotic sensor data and manual clinical assessment scores would enable more precise tracking of the time course of recovery after injury and reduce the need for time-consuming manual assessments by skilled personnel. This study used measurements from robotic rehabilitation sessions to predict clinical scores in a traumatic cervical spinal cord injury (SCI) population. A retrospective analysis was conducted on data collected from subjects using the Armeo Spring (Hocoma, AG) in three rehabilitation centers. Fourteen predictive variables were explored, relating to range-of-motion, movement smoothness, and grip ability. Regression models using up to four predictors were developed to describe the following clinical scores: the GRASSP (consisting of four sub-scores), the ARAT, and the SCIM. The resulting adjusted R(2) value was highest for the GRASSP "Quantitative Prehension" component (0.78), and lowest for the GRASSP "Sensibility" component (0.54). In contrast to comparable studies in stroke survivors, movement smoothness was least beneficial for predicting clinical scores in SCI. Prediction of upper-limb clinical scores in SCI is feasible using measurements from a robotic rehabilitation device, without the need for dedicated assessment procedures.