Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Jessa Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
Time Frame: Between baseline and end of study (=8 weeks)
UL assessment - Function
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks
Time Frame: Between baseline and first 4 weeks of study
UL assessment - Function
Change from Action Research Arm Test at 4 weeks
Time Frame: Between baseline and first 4 weeks of study
UL Assessment - Activities
Change from Action Research Arm Test at 8 weeks
Time Frame: Between baseline and end of study (=8 weeks)
UL Assessment - Activities
Secondary Outcomes
- Change from Box & Block test at 4 weeks(Between baseline and first 4 weeks of study)
- Change from Jebsen Taylor hand function test at 8 weeks(Between baseline and end of study (=8 weeks))
- Change from Rivermead Motor Assessment Arm function at 4 weeks(Between baseline and first 4 weeks of study)
- Change from Rivermead Motor Assessment Arm function at 8 weeks(Between baseline and end of study (=8 weeks))
- Change from Stroke upper limb capacity scale (SULCS) at 4 weeks(Between baseline and first 4 weeks of study)
- Change from Stroke upper limb capacity scale (SULCS) at 8 weeks(Between baseline and end of study (=8 weeks))
- Change from Jebsen Taylor hand function test at 4 weeks(Between baseline and first 4 weeks of study)
- Change from Box & Block test at 8 weeks(Between baseline and end of study (=8 weeks))