Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

NCT04584177 | Completed

• 1 other identifier: Study 19.27
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change from Jebsen Taylor hand function test at 4 weeks

  Between baseline and first 4 weeks of study

• Change from Jebsen Taylor hand function test at 8 weeks

  Between baseline and end of study (=8 weeks)

• Change from Rivermead Motor Assessment Arm function at 4 weeks

  Between baseline and first 4 weeks of study

• Change from Rivermead Motor Assessment Arm function at 8 weeks

  Between baseline and end of study (=8 weeks)

• Change from Stroke upper limb capacity scale (SULCS) at 4 weeks

  Between baseline and first 4 weeks of study

Study Arms (2)

Arm-hand BOOST + Control

EXPERIMENTAL

First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program

Behavioral: Arm-hand BOOST program; Behavioral: Control program

Control + Arm-hand BOOST

EXPERIMENTAL

First 4 weeks control program, afterwards 4 weeks arm-hand boost program

Behavioral: Arm-hand BOOST program; Behavioral: Control program

Interventions

Arm-hand BOOST program BEHAVIORAL

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.

Arm-hand BOOST + Control; Control + Arm-hand BOOST

Control program BEHAVIORAL

A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

Arm-hand BOOST + Control; Control + Arm-hand BOOST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital, Campus Sint-Ursula

Herk-de-Stad, 3540, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33716948 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah Meyer, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: October 12, 2020
• Study Start: May 9, 2019
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: February 11, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)