Tele-rehabilitation of upper-extremity hemiparesis after stroke: Proof-of-concept randomized controlled trial of in-home Constraint-Induced Movement therapy.

BACKGROUND: Although Constraint-Induced Movement therapy (CIMT) has been deemed efficacious for adults with persistent, mild-to-moderate, post-stroke upper-extremity hemiparesis, CIMT is not available on a widespread clinical basis. Impediments include its cost and travel to multiple therapy appointments. To overcome these barriers, we developed an automated, tele-health form of CIMT. OBJECTIVE: Determine whether in-home, tele-health CIMT has outcomes as good as in-clinic, face-to-face CIMT in adults ≥1-year post-stroke with mild-to-moderate upper-extremity hemiparesis. METHODS: Twenty-four stroke patients with chronic upper-arm extremity hemiparesis were randomly assigned to tele-health CIMT (Tele-AutoCITE) or in-lab CIMT. All received 35 hours of treatment. In the tele-health group, an automated, upper-extremity workstation with built-in sensors and video cameras was set-up in participants' homes. Internet-based audio-visual and data links permitted supervision of treatment by a trainer in the lab. RESULTS: Ten patients in each group completed treatment. All twenty, on average, showed very large improvements immediately afterwards in everyday use of the more-affected arm (mean change on Motor Activity Log Arm Use scale = 2.5 points, p < 0.001, d' = 3.1). After one-year, a large improvement from baseline was still present (mean change = 1.8, p < 0.001, d' = 2). Post-treatment outcomes in the tele-health group were not inferior to those in the in-lab group. Neither were participants' perceptions of satisfaction with and difficulty of the interventions. Although everyday arm use was similar in the two groups after one-year (mean difference = -0.1, 95% CI = -1.3-1.0), reductions in the precision of the estimates of this parameter due to drop-out over follow-up did not permit ruling out that the tele-health group had an inferior long-term outcome. CONCLUSIONS: This proof-of-concept study suggests that Tele-AutoCITE produces immediate benefits that are equivalent to those after in-lab CIMT in stroke survivors with chronic upper-arm extremity hemiparesis. Cost savings possible with this tele-health approach remain to be evaluated.

Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit: The Bringing Rehabilitation to American Veterans Everywhere Project.

Constraint-induced movement therapy (CI therapy) has been shown to reduce disability for individuals with upper extremity (UE) hemiparesis following different neurologic injuries. This article describes the study design and methodological considerations of the Bringing Rehabilitation to American Veterans Everywhere (BRAVE) Project, a randomized controlled trial of CI therapy to improve the motor deficit of participants with chronic and subacute traumatic brain injury. Our CI therapy protocol comprises 4 major components: (1) intensive training of the more-affected UE for target of 3 hour/day for 10 consecutive weekdays, (2) a behavioral technique termed shaping during training, (3) a "transfer package," 0.5 hour/day, of behavioral techniques to transfer therapeutic gains from the treatment setting to the life situation, and (4) prolonged restraint of use of the UE not being trained. The primary endpoint is posttreatment change on the Motor Activity Log, which assesses the use of the more-affected arm outside the laboratory in everyday life situations. Data from a number of secondary outcome measures are also being collected and can be categorized as physical, genomic, biologic, fitness, cognitive/behavioral, quality of life, and neuroimaging measures.

Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function.

BACKGROUND: Constraint-Induced Movement therapy (CIMT) has controlled evidence of efficacy for improving real-world paretic limb use in non-progressive physically disabling disorders (stroke, cerebral palsy). OBJECTIVE: This study sought to determine whether this therapy can produce comparable results with a progressive disorder such as multiple sclerosis (MS). We conducted a preliminary phase II randomized controlled trial of CIMT versus a program of complementary and alternative medicine (CAM) treatments for persons with MS, to evaluate their effect on real-world disability. METHODS: Twenty adults with hemiparetic MS underwent 35 hours of either CIMT or CAM over 10 consecutive weekdays. The primary clinical outcome was change from pretreatment on the Motor Activity Log (MAL). RESULTS: The CIMT group improved more on the MAL (2.7 points, 95% confidence interval 2.2-3.2) than did the CAM group (0.5 points, 95% confidence interval -0.1 to 1.1; P < .001). These results did not change at 1-year follow-up, indicating long-term retention of functional benefit for CIMT. The treatments were well tolerated and without adverse events. CONCLUSION: These results suggest that CIMT can increase real-world use of the more-affected arm in patients with MS for at least 1 year. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01081275.

Rehabilitation of stroke patients with plegic hands: Randomized controlled trial of expanded Constraint-Induced Movement therapy.

PURPOSE: To evaluate the efficacy of an expanded form of Constraint-Induced Movement Therapy (eCIMT) that renders CIMT, originally designed for treating mild-to-moderate upper-extremity hemiparesis, suitable for treating severe hemiparesis. METHODS: Twenty-one adults ≥1 year after stroke with severe upper-extremity hemiparesis (with little or no capacity to make movements with the more-affected hand) were randomly assigned to eCIMT (n = 10), a placebo-control procedure (n = 4), or usual care (n = 7). The participants who received usual care were crossed over to eCIMT four months after enrollment. The CIMT protocol was altered to include fitting of orthotics and adaptive equipment, selected neurodevelopmental techniques, and electromyography-triggered functional electrical stimulation. Treatment was given for 15 consecutive weekdays with 6 hours of therapy scheduled daily for the immediate eCIMT group and 3.5 hours daily for the cross-over eCIMT group. RESULTS: At post-treatment, the immediate eCIMT group showed significant gains relative to the combination of the control groups on the Grade-4/5 Motor Activity Log (MAL; mean = 1.5 points, P < 0.001, f = 4.2) and a convergent measure, the Canadian Occupational Performance Measure (COPM; mean = 2.3, P = 0.014, f = 1.1; f values ≥0.4 are considered large, on the COPM changes ≥2 are considered clinically meaningful). At 1-year follow-up, the MAL gains in the immediate eCIMT group were only 13% less than at post-treatment. The short and long-term outcomes of the crossover eCIMT group were similar to those of the immediate eCIMT group. CONCLUSIONS: This small, randomized controlled trial (RCT) suggests that eCIMT produces a large, meaningful, and persistent improvement in everyday use of the more-affected arm in adults with severe upper-extremity hemiparesis long after stroke. These promising findings warrant confirmation by a large RCT.

The Pediatric SmartShoe: Wearable Sensor System for Ambulatory Monitoring of Physical Activity and Gait.

Cerebral palsy (CP) is a group of nonprogressive neuro-developmental conditions occurring in early childhood that causes movement disorders and physical disability. Measuring activity levels and gait patterns is an important aspect of CP rehabilitation programs. Traditionally, such programs utilize commercially available laboratory systems, which cannot to be utilized in community living. In this study, a novel, shoe-based, wearable sensor system (pediatric SmartShoe) was tested on 11 healthy children and 10 children with CP to validate its use for monitoring of physical activity and gait. Novel data processing techniques were developed to remove the effect of orthotics on the sensor signals. Machine learning models were developed to automatically classify the activities of daily living. The temporal gait parameters estimated from the SmartShoe data were compared against reference measurements on a GAITRite mat. A leave-one-out cross-validation method indicated a 95.3% average accuracy of activity classification (for sitting, standing, and walking) for children with CP and 96.2% for healthy children. Average relative errors in gait parameter estimation (gait cycle, stance, swing, and step time, % single support time on both lower extremities, along with cadence) ranged from 0.2% to 6.4% (standard deviation range = 1.4%-9.9%). These results suggest that the pediatric SmartShoe can accurately measure physical activity and gait of children with CP and can potentially be used for ambulatory monitoring.

An enhanced protocol for constraint-induced aphasia therapy II: a case series.

PURPOSE: The initial version of Constraint-Induced Aphasia Therapy (CIAT I) consisted of a single exercise. This study sought to evaluate the feasibility for future trials of an expanded and restructured protocol designed to increase the efficacy of CIAT I. METHOD: The subjects were 4 native English speakers with chronic stroke who exhibited characteristics of moderate Broca's aphasia. Treatment was carried out for 3.5 hr/day for 15 consecutive weekdays. It consisted of 3 components: (a) intensive training by a behavioral method termed shaping using a number of expressive language exercises in addition to the single original language card game, (b) strong discouragement of attempts to use gesture or other nonverbal means of communication, and (c) a transfer package of behavioral techniques to promote transfer of treatment gains from the laboratory to real-life situations. RESULTS: Participation in speech in the life situation improved significantly after treatment. The effect sizes (i.e., d') in this domain were ≥ 2.2; d' values ≥ 0.8 are considered large. Improvement in language ability on a laboratory test, the Western Aphasia Battery-Revised (Kertesz, 2006), did not achieve statistical significance, although the effect size was large--that is, 1.3 (13.1 points). CONCLUSION: These pilot results suggest in preliminary fashion that CIAT II may produce significant improvements in everyday speech.

Method for enhancing real-world use of a more affected arm in chronic stroke: transfer package of constraint-induced movement therapy.

BACKGROUND AND PURPOSE: Constraint-induced movement therapy is a set of treatments for rehabilitating motor function after central nervous system damage. We assessed the roles of its 2 main components. METHODS: A 2 × 2 factorial components analysis with random assignment was conducted. The 2 factors were type of training and presence/absence of a set of techniques to facilitate transfer of therapeutic gains from the laboratory to the life situation (Transfer Package; TP). Participants (N=40) were outpatients ≥ 1-year after stroke with hemiparesis. The different treatments, which in each case targeted the more affected arm, lasted 3.5 hours/d for 10 weekdays. Spontaneous use of the more affected arm in daily life and maximum motor capacity of that arm in the laboratory were assessed with the Motor Activity Log and the Wolf Motor Function Test, respectively. RESULTS: Use of the TP, regardless of the type of training received, resulted in Motor Activity Log gains that were 2.4 times as large as the gains in its absence (P<0.01). These clinical results parallel previously reported effects of the TP on neuroplastic change. Both the TP and training by shaping enhanced gains on the Wolf Motor Function Test (P<0.05). The Motor Activity Log gains were retained without loss 1 year after treatment. An additional substudy (N=10) showed that a single component of the TP, weekly telephone contact with participants for 1 month after treatment, doubled Motor Activity Log scores at 6-month follow-up. CONCLUSIONS: The TP is a method for enhancing both spontaneous use of a more affected arm after chronic stroke and its maximum motor capacity. Shaping enhances the latter.

Constraint-induced movement therapy combined with conventional neurorehabilitation techniques in chronic stroke patients with plegic hands: a case series.

OBJECTIVE: To determine whether the combination of Constraint-Induced Movement Therapy (CIMT) and conventional rehabilitation techniques can produce meaningful motor improvement in chronic stroke patients with initially fisted hands. DESIGN: Case series. SETTING: University hospital outpatient laboratory. PARTICIPANTS: Consecutive sample (N=6) >1 year poststroke with plegic hands. INTERVENTIONS: Treatment consisted of an initial period of 3 weeks (phase A) when adaptive equipment in the home, orthotics, and splints were employed to improve ability to engage in activities of daily living. This was continued in phase B, when CIMT and selected neurodevelopmental treatment techniques were added. MAIN OUTCOME MEASURES: Motor Activity Log (MAL), accelerometry, Fugl-Meyer Motor Assessment (F-M). RESULTS: Patients exhibited a large improvement in spontaneous real-world use of the more-affected arm (mean lower-functioning MAL change=1.3±0.4 points; P<.001; d'=3.0) and a similar pattern of increase in an objective measure of real-world more-affected arm movement (mean change in ratio of more- to less-affected arm accelerometer recordings=0.12±0.1 points; P=.016; d'=1.2). A large improvement in motor status was also recorded (mean F-M change=5.3±3.3 points; P=.005; d'=1.6). CONCLUSIONS: The findings of this pilot study suggest that stroke patients with plegic hands can benefit from CIMT combined with some conventional rehabilitation techniques, even long after brain injury. More research is warranted.

Constraint-induced movement therapy for the lower extremities in multiple sclerosis: case series with 4-year follow-up.

OBJECTIVE: To evaluate in a preliminary manner the feasibility, safety, and efficacy of Constraint-Induced Movement therapy (CIMT) of persons with impaired lower extremity use from multiple sclerosis (MS). DESIGN: Clinical trial with periodic follow-up for up to 4 years. SETTING: University-based rehabilitation research laboratory. PARTICIPANTS: A referred sample of ambulatory adults with chronic MS (N=4) with at least moderate loss of lower extremity use (average item score ≤6.5/10 on the functional performance measure of the Lower Extremity Motor Activity Log [LE-MAL]). INTERVENTIONS: CIMT was administered for 52.5 hours over 3 consecutive weeks (15 consecutive weekdays) to each patient. MAIN OUTCOME MEASURES: The primary outcome was the LE-MAL score at posttreatment. Secondary outcomes were posttreatment scores on laboratory assessments of maximal lower extremity movement ability. RESULTS: All the patients improved substantially at posttreatment on the LE-MAL, with smaller improvements on the laboratory motor measures. Scores on the LE-MAL continued to improve for 6 months afterward. By 1 year, patients remained on average at posttreatment levels. At 4 years, half of the patients remained above pretreatment levels. There were no adverse events, and fatigue ratings were not significantly changed by the end of treatment. CONCLUSIONS: This initial trial of lower extremity CIMT for MS indicates that the treatment can be safely administered, is well tolerated, and produces substantially improved real-world lower extremity use for as long as 4 years afterward. Further trials are needed to determine the consistency of these findings.

A treatment for a chronic stroke patient with a plegic hand combining CI therapy with conventional rehabilitation procedures: case report.

Constraint-Induced Movement therapy (CI therapy) is a recognized rehabilitation approach for persons having stroke with mild to moderately severe motor upper extremity deficits. To date, no rehabilitation treatment protocol has been proven effective that addresses both motor performance and spontaneous upper extremity use in the life situation for chronic stroke participants having severe upper extremity impairment with no active finger extension or thumb abduction. This case report describes treatment of a chronic stroke participant with a plegic hand using a CI therapy protocol that combines CI therapy with selected occupational and physical therapy techniques. Treatment consisted of six sessions of adaptive equipment and upper extremity orthotics training followed by a three-week, six-hour daily intervention of CI therapy plus neurodevelopmental treatment. Outcome measures included the Motor Activity Log for very low functioning patients (Grade 5 MAL), upper extremity portion of the Fugl-Meyer Motor Assessment, Graded Wolf Motor Function Test - for very low functioning patients (gWMFT- Grade 5), and Modified Ashworth Scale. The participant showed improvement on each outcome measure with the largest improvement on the Grade 5 MAL. In follow-up, the participant had good retention of his gains in motor performance and use of his more affected arm for real world activities after 3 months; after a one-week brush-up at 3 months, and at one year post-treatment.

Constraint-induced movement therapy for recovery of upper-limb function following traumatic brain injury.

A volunteer sample of 22 participants with chronic traumatic brain injury (TBI) (onset >1 year) and relative hemiplegia that revealed moderate disability in the more-affected upper limb (UL) participated. Constraint-induced (CI) movement therapy (CI therapy) was employed for a 2-week period; treatments included massed practice, shaping of the more-affected UL, behavioral contracts, and other behavioral techniques for affecting transfer to a real-world setting. We used the Wolf Motor Function Test, the Fugl-Meyer Motor Performance Assessment, and the Motor Activity Log to measure outcomes. All outcome measures improved significantly as a result of the intervention. More-adherent participants had more improvement compared with less-adherent participants. These preliminary results suggest that CI therapy may be effective for improving UL motor function following chronic TBI.