Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Arm-hand BOOST program; Behavioral: Control program

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Herk-de-Stad, Belgium, 3540
    • Jessa Hospital, Campus Sint-Ursula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm-hand BOOST + Control; First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program	Behavioral: Arm-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.; Behavioral: Control program; A dose-matched program of strengthening exercises for the lower limbs and general reconditioning
Experimental: Control + Arm-hand BOOST; First 4 weeks control program, afterwards 4 weeks arm-hand boost program	Behavioral: Arm-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.; Behavioral: Control program; A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks	UL assessment - Function	Between baseline and first 4 weeks of study
Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks	UL assessment - Function	Between baseline and end of study (=8 weeks)
Change from Action Research Arm Test at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Change from Action Research Arm Test at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Jebsen Taylor hand function test at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Change from Jebsen Taylor hand function test at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Change from Rivermead Motor Assessment Arm function at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Change from Rivermead Motor Assessment Arm function at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Change from Stroke upper limb capacity scale (SULCS) at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Change from Stroke upper limb capacity scale (SULCS) at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Change from Box & Block test at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Change from Box & Block test at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Sarah Meyer, PhD, Jessa Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): November 3, 2020
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Study 19.27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No