Clinical trial NCT04584177: Arm-hand Boost Program During Inpatient Rehabilitation After Stroke
Official title: Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks
timeFrame: Between baseline and first 4 weeks of study
measure: Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
timeFrame: Between baseline and end of study (=8 weeks)
measure: Change from Action Research Arm Test at 4 weeks
timeFrame: Between baseline and first 4 weeks of study
measure: Change from Action Research Arm Test at 8 weeks
timeFrame: Between baseline and end of study (=8 weeks)
Secondary outcomes:
measure: Change from Jebsen Taylor hand function test at 4 weeks
timeFrame: Between baseline and first 4 weeks of study
measure: Change from Jebsen Taylor hand function test at 8 weeks
timeFrame: Between baseline and end of study (=8 weeks)
measure: Change from Rivermead Motor Assessment Arm function at 4 weeks
timeFrame: Between baseline and first 4 weeks of study
measure: Change from Rivermead Motor Assessment Arm function at 8 weeks
timeFrame: Between baseline and end of study (=8 weeks)
measure: Change from Stroke upper limb capacity scale (SULCS) at 4 weeks
timeFrame: Between baseline and first 4 weeks of study
measure: Change from Stroke upper limb capacity scale (SULCS) at 8 weeks
timeFrame: Between baseline and end of study (=8 weeks)
measure: Change from Box & Block test at 4 weeks
timeFrame: Between baseline and first 4 weeks of study
measure: Change from Box & Block test at 8 weeks
timeFrame: Between baseline and end of study (=8 weeks)
Other outcomes:
Locations:
city: Herk-de-Stad
country: Belgium
facility: Jessa Hospital, Campus Sint-Ursula
Study officials:
affiliation: Jessa Hospital
name: Sarah Meyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.