Arm-hand Boost Program During Inpatient Rehabilitation After Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: Arm-hand BOOST programBehavioral: Control program
- Registration Number
- NCT04584177
- Lead Sponsor
- Jessa Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm-hand BOOST + Control Arm-hand BOOST program First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program Arm-hand BOOST + Control Control program First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program Control + Arm-hand BOOST Control program First 4 weeks control program, afterwards 4 weeks arm-hand boost program Control + Arm-hand BOOST Arm-hand BOOST program First 4 weeks control program, afterwards 4 weeks arm-hand boost program
- Primary Outcome Measures
Name Time Method Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks Between baseline and end of study (=8 weeks) UL assessment - Function
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks Between baseline and first 4 weeks of study UL assessment - Function
Change from Action Research Arm Test at 4 weeks Between baseline and first 4 weeks of study UL Assessment - Activities
Change from Action Research Arm Test at 8 weeks Between baseline and end of study (=8 weeks) UL Assessment - Activities
- Secondary Outcome Measures
Name Time Method Change from Rivermead Motor Assessment Arm function at 8 weeks Between baseline and end of study (=8 weeks) UL Assessment - Activities
Change from Stroke upper limb capacity scale (SULCS) at 4 weeks Between baseline and first 4 weeks of study UL Assessment - Activities
Change from Stroke upper limb capacity scale (SULCS) at 8 weeks Between baseline and end of study (=8 weeks) UL Assessment - Activities
Change from Jebsen Taylor hand function test at 8 weeks Between baseline and end of study (=8 weeks) UL Assessment - Activities
Change from Rivermead Motor Assessment Arm function at 4 weeks Between baseline and first 4 weeks of study UL Assessment - Activities
Change from Box & Block test at 4 weeks Between baseline and first 4 weeks of study UL Assessment - Activities
Change from Jebsen Taylor hand function test at 4 weeks Between baseline and first 4 weeks of study UL Assessment - Activities
Change from Box & Block test at 8 weeks Between baseline and end of study (=8 weeks) UL Assessment - Activities
Trial Locations
- Locations (1)
Jessa Hospital, Campus Sint-Ursula
🇧🇪Herk-de-Stad, Belgium