Stroke
Conditions
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.
Interventions
BEHAVIORALArm-hand BOOST program
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.
BEHAVIORALControl program
A dose-matched program of strengthening exercises for the lower limbs and general reconditioning
Sponsors
Jessa Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks | Between baseline and first 4 weeks of study | UL assessment - Function |
| Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks | Between baseline and end of study (=8 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 Rivermead Motor Assessment Arm function at 8 weeks | Between baseline and end of study (=8 weeks) | UL Assessment - Activities |
Countries
Belgium
Outcome results
None listed