Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

Study Overview
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Brief Summary
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A pilot cross-over RCT including participants with sub-acute stroke is conducted in an inpatient rehabilitation setting. The experimental group (EG) receives an arm-hand boost program on top of their usual care program. The control group (CG) receives a dose-matched program of strengthening exercises for the lower limbs and general reconditioning. After 4 weeks, a cross-over is performed. Before, after 4 weeks and after 8 weeks of additional therapy, different clinical outcome measures for the upper limb are administered.

Official Title
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Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Arm-hand BOOST program
* Behavioral: Control program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first stroke, as defined by WHO, minimal stay of 4 weeks in inpatient setting at study start minimally 18 years old being able to sit independently (trunk control test, item 3 = 25), motor impairment in the upper limb (Fugl-Meyer assessment, stage 2 (synergies): 8-17p, or stage 2: <8p combined witht stage 5 (hand): >6p sufficient cooperation to perform intervention and evaluations Exclusion Criteria: musculoskeletal and/or other neurological impairments with permanent damage that may hinder the study subdural hematoma, tumor, encephalitis, trauma, or other that lead to similar symptoms as stroke severe communication, cognitive or language impairments that hinder the investigations no written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm-hand BOOST + Control<br>First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program | Behavioral: Arm-hand BOOST program<br>* The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.<br>Behavioral: Control program<br>* A dose-matched program of strengthening exercises for the lower limbs and general reconditioning<br>|
| Experimental: Control + Arm-hand BOOST<br>First 4 weeks control program, afterwards 4 weeks arm-hand boost program | Behavioral: Arm-hand BOOST program<br>* The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.<br>Behavioral: Control program<br>* A dose-matched program of strengthening exercises for the lower limbs and general reconditioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks | UL assessment - Function | Between baseline and first 4 weeks of study | 
| Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks | UL assessment - Function | Between baseline and end of study (=8 weeks) | 
| Change from Action Research Arm Test at 4 weeks | UL Assessment - Activities | Between baseline and first 4 weeks of study | 
| Change from Action Research Arm Test at 8 weeks | UL Assessment - Activities | Between baseline and end of study (=8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Jebsen Taylor hand function test at 4 weeks | UL Assessment - Activities | Between baseline and first 4 weeks of study | 
| Change from Jebsen Taylor hand function test at 8 weeks | UL Assessment - Activities | Between baseline and end of study (=8 weeks) | 
| Change from Rivermead Motor Assessment Arm function at 4 weeks | UL Assessment - Activities | Between baseline and first 4 weeks of study | 
| Change from Rivermead Motor Assessment Arm function at 8 weeks | UL Assessment - Activities | Between baseline and end of study (=8 weeks) | 
| Change from Stroke upper limb capacity scale (SULCS) at 4 weeks | UL Assessment - Activities | Between baseline and first 4 weeks of study | 
| Change from Stroke upper limb capacity scale (SULCS) at 8 weeks | UL Assessment - Activities | Between baseline and end of study (=8 weeks) | 
| Change from Box & Block test at 4 weeks | UL Assessment - Activities | Between baseline and first 4 weeks of study | 
| Change from Box & Block test at 8 weeks | UL Assessment - Activities | Between baseline and end of study (=8 weeks) |