Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial.

BACKGROUND: Multi-site studies in stroke rehabilitation are important for determining whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positive outcomes. This study is the first multi-site clinical trial of a novel intervention for post-stroke upper limb rehabilitation called contralaterally controlled functional electrical stimulation (CCFES). Previous pilot and single-site studies showed positive effects of CCFES on upper limb impairment and hand dexterity in stroke survivors. The main purpose of this study is to confirm and demonstrate the efficacy of CCFES in a larger group of most likely responders across multiple clinical sites. METHODS: Up to 129 stroke survivors with moderate to severe upper extremity hemiparesis at 4 clinical trial sites will be randomized to CCFES, cyclic neuromuscular electrical stimulation (cNMES), or task-oriented-training (TOT). Participants will receive 12 weeks of group-specific therapy. Blinded assessments of upper limb impairment and activity limitation, quality of life, and neurophysiology will be used to compare outcomes at baseline, after treatment, and up to 6 months post-treatment. The primary endpoint is change in dexterity from baseline to 6 months post-treatment. DISCUSSION: Loss of hand function following stroke is a major rehabilitation problem affecting millions of people per year globally. More effective rehabilitation therapies are needed to restore hand function in these individuals. This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or TOT, and will begin to elucidate the different mechanisms underlying each of the three treatments. This multi-site study is a critical step in advancing a novel method of rehabilitation toward clinical translation and widespread dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT03574623 . Registered prior to first enrollment; July 2, 2018.

Adding Contralaterally Controlled Electrical Stimulation of the Triceps to Contralaterally Controlled Functional Electrical Stimulation of the Finger Extensors Reduces Upper Limb Impairment and Improves Reachable Workspace but not Dexterity: A Randomized Controlled Trial.

OBJECTIVE: Different methods of neuromuscular electrical stimulation may be used for poststroke upper limb rehabilitation. This study evaluated the effects of contralaterally controlled functional electrical stimulation of the triceps and finger extensors. DESIGN: This is a randomized controlled trial of 67 participants who were less than 2 yrs poststroke and assigned to the following: (a) arm + hand contralaterally controlled functional electrical stimulation, (b) hand contralaterally controlled functional electrical stimulation, or (c) arm + hand cyclic neuromuscular electrical stimulation. Participants were prescribed 10 sessions/week of assigned electrical stimulation at home plus 24 sessions of functional task practice in the laboratory for 12 wks. The primary outcome measure was the Box and Blocks Test. Secondary measures included reachable workspace, Upper Extremity Fugl-Meyer, Stroke Upper Limb Capacity Scale, Arm Motor Abilities Test, and Motor Activity Log. RESULTS: There were no significant between-group differences on the Box and Blocks Test. At 6 mos after treatment, arm + hand contralaterally controlled functional electrical stimulation improved reachable workspace more than hand contralaterally controlled functional electrical stimulation, between-group difference of 264 (95% confidence interval = 28-500) cm and more than arm + hand cyclic neuromuscular electrical stimulation, between-group difference of 281 (95% confidence interval = 22-540) cm. Arm + hand contralaterally controlled functional electrical stimulation improved Upper Extremity Fugl-Meyer score more than hand contralaterally controlled functional electrical stimulation, between-group difference of 6.7 (95% confidence interval = 0.6-12.7). The between-group differences on the Stroke Upper Limb Capacity Scale and Arm Motor Abilities Test were not significant. CONCLUSIONS: Adding contralaterally controlled elbow extension to hand contralaterally controlled functional electrical stimulation does not improve on gains in hand dexterity, but it further reduces upper limb impairment and improves reachable workspace measured in the laboratory. However, these additional benefits may not be large enough to be perceived by stroke survivors when they are performing activities of daily living at home.

Ability of people with post-stroke hemiplegia to self-administer FES-assisted hand therapy video games at home: An exploratory case series.

INTRODUCTION: This article describes the development and initial clinical testing of an innovative home-based treatment for upper extremity hemiplegia that integrates contralaterally controlled functional electrical stimulation with hand therapy video games. METHODS: We explored the ability of seven participants with moderate-to-severe hand impairment to self-administer 12 weeks of contralaterally controlled functional electrical stimulation video game therapy at home for 10 h/week and in-lab with a therapist for four h/week. Clinical suitability was assessed by device usage logs, qualitative surveys, and clinical motor and cognitive outcomes. RESULTS: Three participants completed the study with > 95% compliance and four did not. Factors linked to incompletion included development of trigger finger in the non-paretic hand, acceptance of a new full-time job, residence relocation, and persistence of drowsiness from anti-spasticity medication. Those who completed the treatment perceived qualitative benefits and experienced gains in motor and cognitive outcomes. CONCLUSION: Individuals with moderate-to-severe chronic post-stroke upper extremity hemiplegia can self-administer contralaterally controlled functional electrical stimulation video game therapy for up to 90 min/day at home. We also identified social and physiological factors that may preclude its use for daily home treatment. Further studies are warranted and are in progress to estimate treatment effect and optimal dose of this intervention.

Convergent Validity and Responsiveness of the SULCS.

OBJECTIVE: To evaluate the convergent validity and responsiveness of the Stroke Upper Limb Capacity Scale (SULCS) in comparison to the Arm Motor Ability Test (AMAT), the Box and Blocks Test (BBT), and the upper limb Fugl-Meyer Assessment (FMA). The SULCS is a relatively new measure that was designed to be easier to score and less time consuming than some existing measures. DESIGN: Prospective repeated-measures design. SETTING: Clinical research laboratory of a large public hospital. PARTICIPANTS: Patients (N=61) <2 years poststroke with moderate to severe upper limb hemiparesis. INTERVENTION: Participants received 12 weeks of therapy that included neuromuscular electrical stimulation of the paretic finger and thumb extensors. The SULCS, AMAT, BBT, and FMA were administered at weeks 0, 6, 12 (end of therapy), 20, 28, and 36 (6mo post-therapy). MAIN OUTCOME MEASURES: Convergent validity was evaluated with Spearman's correlation coefficients between pairs of measures at each time point. Responsiveness from 0 to 12 weeks and 0 to 36 weeks was evaluated with the standardized response mean (SRM). RESULTS: The SULCS demonstrated strong correlation with the AMAT (ρ=0.81-0.93), BBT (ρ=0.73-0.92), and FMA (ρ=0.78-0.92), at all 6 time points. All 4 measures had moderate to large SRMs (SULCS, 0.71-0.77; AMAT, 0.83-0.97; BBT, 0.73-0.82; FMA, 0.75-0.76). There was no significant difference in responsiveness among the 4 measures. CONCLUSIONS: The results support the use of the SULCS to measure upper limb capacity in patients who are less than 2 years poststroke with moderate to severe hemiplegia.

Contralaterally controlled functional electrical stimulation for recovery of elbow extension and hand opening after stroke: a pilot case series study.

OBJECTIVE: The aims of this study were to determine whether patients with moderate-to-severe upper limb hemiplegia could use contralaterally controlled functional electrical stimulation at the arm and hand (Arm+Hand CCFES) at home and to evaluate the feasibility of Arm+Hand CCFES to reduce arm and hand motor impairment. DESIGN: With Arm+Hand CCFES, the paretic elbow and hand extensors were stimulated with intensities proportional to the degree of elbow extension and hand opening, respectively, of the contralateral unimpaired side. For 12 wks, four participants with chronic (≥6 mos) upper limb hemiplegia received ∼7 hrs per week of self-administered home-based stimulation-mediated elbow extension and hand opening exercise plus ∼2.5 hrs per week of therapist-supervised laboratory-based stimulation-assisted functional task practice. Assessments of upper limb impairment were made at pretreatment, posttreatment, and 1 mo after treatment. RESULTS: All four participants were able to use the Arm+Hand CCFES system at home either independently or with very minimal assistance from a caregiver. All four participants had increases in the Fugl-Meyer score (1-9 points) and the Wolf Motor Function Test (0.2-0.8 points) and varying degrees of improvement in maximum hand opening, maximum elbow extension, and simultaneous elbow extension and hand opening. CONCLUSIONS: Arm+Hand CCFES can be successfully administered in stroke patients with moderate-to-severe impairment and can reduce various aspects of upper limb impairment. A larger efficacy study is warranted.

Implanted neuroprosthesis for assisting arm and hand function after stroke: a case study.

Loss of arm and hand function is common after stroke. An implantable, 12-channel, electromyogram (EMG)-controlled functional electrical stimulation neuroprosthesis (NP) may be a viable assistive device for upper-limb hemiplegia. In this study, a research participant 4.8 yr poststroke underwent presurgical screening, surgical installation of the NP, training, and assessment of upper-limb impairment, activity limitation, and satisfaction over a 2.3 yr period. The NP increased active range of finger extension from 3 to 96 degrees, increased lateral pinch force from 16 to 29 N, increased the number of objects from 1 to 4 out of 6 that the participant could grasp and place in a Grasp-Release Test, and increased the Arm Motor Abilities Test score by 0.3 points. The upper-limb Fugl-Meyer score increased from 27 at baseline to 36 by the end of the study. The participant reported using the NP at home 3-4 d/wk, up to 3 h/d for exercise and household tasks. The effectiveness of the NP to assist with activities of daily living was dependent on the degree of flexor tone, which varied with task and level of fatigue. The EMG-based control strategy was not successfully implemented; button presses were used instead. Further advancements in technology may improve ease of use and address limitations caused by muscle spasticity.

Contralaterally controlled functional electrical stimulation for stroke rehabilitation.

Contralaterally controlled functional electrical stimulation (CCFES) is an innovative method of delivering neuromuscular electrical stimulation for rehabilitation of paretic limbs after stroke. It is being studied to evaluate its efficacy in improving recovery of arm and hand function and ankle dorsiflexion in chronic and subacute stroke patients. The initial studies provide preliminary evidence supporting the efficacy of CCFES.

Contralaterally controlled functional electrical stimulation for upper extremity hemiplegia: an early-phase randomized clinical trial in subacute stroke patients.

BACKGROUND: Contralaterally controlled functional electrical stimulation (CCFES) is an experimental treatment intended to improve hand function after stroke. OBJECTIVE: To compare the effects of 6 weeks of CCFES versus cyclic neuromuscular electrical stimulation (NMES) on upper extremity impairment and activity limitation in patients ≤6 months poststroke. METHODS: Twenty-one participants were randomized to CCFES or cyclic NMES. Treatment for both groups consisted of daily stimulation-assisted repetitive hand-opening exercise at home plus twice-weekly lab sessions of functional task practice. Assessments were made at pretreatment and posttreatment and at 1 month and 3 months posttreatment. They included maximum voluntary finger extension angle, finger movement tracking error, upper extremity Fugl-Meyer score, Box and Blocks test, and Arm Motor Abilities test. Treatment effects were estimated using a 2-factor repeated measures analysis of variance with the value of the baseline measure as a covariate. RESULTS: Seventeen patients completed the treatment phase (9 CCFES, 8 cyclic NMES). At all posttreatment time points, CCFES produced larger improvements than cyclic NMES on every outcome measure. Maximum voluntary finger extension showed the largest treatment effect, with a mean group difference across the posttreatment time points of 28° more finger extension for CCFES. CONCLUSIONS: The results favor CCFES over cyclic NMES though the small sample size limits the statistical power of the study. The effect size estimates from this study will be used to power a larger trial.

Intramuscular electrical stimulation for upper limb recovery in chronic hemiparesis: an exploratory randomized clinical trial.

BACKGROUND: Surface electrical stimulation (ES) has been shown to improve the motor impairment of stroke survivors. However, surface ES can be painful and motor activation can be inconsistent from session to session. Percutaneous intramuscular ES may be an effective alternative. OBJECTIVE: Evaluate the effectiveness of percutaneous intramuscular ES in facilitating the recovery of the hemiparetic upper limb of chronic stroke survivors. METHODS: A total of 26 chronic stroke survivors were randomly assigned to percutaneous intramuscular ES for hand opening (n = 13) or percutaneous ES for sensory stimulation only (n = 13). The intramuscular ES group received cyclic, electromyography (EMG)-triggered or EMG-controlled ES depending on baseline motor status. All participants received 1 hour of stimulation per day for 6 weeks. After completion of ES, participants received 18 hours of task-specific functional training. The primary outcome measure was the Fugl-Meyer Motor Assessment. Secondary measures included the Arm Motor Ability Test and delay and termination of EMG activity. Outcomes were assessed in a blinded manner at baseline, at the end of ES, at the end of functional training, and at 1, 3, and 6 months follow-up. RESULTS: Repeated measure analysis of variance did not yield any significant treatment, or time by treatment interaction effects for any of the outcome measures. CONCLUSION: Percutaneous intramuscular ES does not appear to be any more effective than sensory ES in enhancing the recovery of the hemiparetic upper limb among chronic stroke survivors. However, because of the exploratory nature of the study and its inherent limitations, conclusions must be drawn with caution.

A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study.

BACKGROUND: Loss of finger extension is common after stroke and can severely limit hand function. Contralaterally controlled functional electrical stimulation (CCFES) is a new treatment aimed at restoring volitional finger and thumb extension. A previous pilot study showed reductions in hand impairment after 6 weeks of CCFES, but the effect did not persist after end of treatment. OBJECTIVE: This study aimed to evaluate the feasibility of achieving greater and more persistent gains with CCFES by increasing the treatment period to 12 weeks. METHODS: CCFES uses neuromuscular electrical stimulation to open the paretic hand in direct proportion to the degree of volitional opening of the unimpaired contralateral hand, which is detected by an instrumented glove. Three subjects with chronic hemiplegia participated in a 12-week CCFES treatment, which consisted of daily CCFES-assisted active repetitive hand-opening exercises and twice weekly functional task practice with CCFES. RESULTS: Maximum voluntary finger extension increased by 101 degrees and 68 degrees for subjects 1 and 2, respectively, but subject 3 had no improvement in finger extension. Box and Block score increased by 6, 15, and 7 blocks, and upper extremity Fugl-Meyer score increased by 11, 15, and 7 points for subjects 1, 2, and 3, respectively. The finger extension gains declined at the 1-month and 3-month follow-up for subjects 1 and 2, but the gains in Box and Block and Fugl-Meyer scores persisted at follow-up. CONCLUSIONS: Greater reductions in hand impairment were achieved by extending the treatment period. The effect and its longevity may be related to baseline impairment level.

Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia.

OBJECTIVE: To assess the feasibility of a new stroke rehabilitation therapy for the hemiparetic hand. DESIGN: Case series. Pre- and postintervention assessment with 1- and 3-month follow-ups. SETTING: Clinical research laboratory of a large public hospital. PARTICIPANTS: Three subjects with chronic (>6mo postcerebrovascular accident) upper-extremity hemiplegia. INTERVENTION: Subjects used an electric stimulator to cause the paretic hand extensor muscles to contract and thereby open the hand. Subjects controlled the intensity of the stimulation, and thus the degree of hand opening, by volitionally opening the unimpaired contralateral hand, which was detected by an instrumented glove. For 6 weeks, subjects used the stimulator to perform active repetitive hand-opening exercises 2 hours daily at home and functional tasks 1.5 hours twice a week in the laboratory. MAIN OUTCOME MEASURES: Maximum voluntary finger extension, maximum voluntary isometric finger-extension moment, finger-movement control, and box and block test (BBT) score at pre- and posttreatment and at 1 month and 3 months posttreatment. RESULTS: Maximum voluntary finger extension increased from baseline to end of treatment and from the end of treatment to 1-month follow-up in 2 subjects. Maximum voluntary isometric finger-extension moment, finger-movement control, and BBT score increased from baseline to the end of treatment and from the end of treatment to 1-month follow-up in all 3 subjects. The improvements generally declined at 3 months. CONCLUSIONS: The results suggest a positive effect on motor impairment, meriting further investigation of the intervention.