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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm-hand BOOST + Control | Experimental | First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program |
|
| Control + Arm-hand BOOST | Experimental | First 4 weeks control program, afterwards 4 weeks arm-hand boost program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm-hand BOOST program | Behavioral | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Meyer, PhD | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital, Campus Sint-Ursula | Herk-de-Stad | 3540 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33716948 | Derived | Meyer S, Verheyden G, Kempeneers K, Michielsen M. Arm-Hand Boost Therapy During Inpatient Stroke Rehabilitation: A Pilot Randomized Controlled Trial. Front Neurol. 2021 Feb 26;12:652042. doi: 10.3389/fneur.2021.652042. eCollection 2021. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Control program | Behavioral | A dose-matched program of strengthening exercises for the lower limbs and general reconditioning |
|
| 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) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |