Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

Not Applicable

Completed

• Conditions: Stroke

• 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

Study Timeline

• Study Start: 2019-05-09
• Status Verified: 2020-08
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-12
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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 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
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 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