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Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Arm-hand BOOST program
Control program
Sponsored by
Jessa Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jessa Hospital, Campus Sint-Ursula

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm-hand BOOST + Control

Control + Arm-hand BOOST

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks
UL assessment - Function
Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
UL assessment - Function
Change from Action Research Arm Test at 4 weeks
UL Assessment - Activities
Change from Action Research Arm Test at 8 weeks
UL Assessment - Activities

Secondary Outcome Measures

Change from Jebsen Taylor hand function test at 4 weeks
UL Assessment - Activities
Change from Jebsen Taylor hand function test at 8 weeks
UL Assessment - Activities
Change from Rivermead Motor Assessment Arm function at 4 weeks
UL Assessment - Activities
Change from Rivermead Motor Assessment Arm function at 8 weeks
UL Assessment - Activities
Change from Stroke upper limb capacity scale (SULCS) at 4 weeks
UL Assessment - Activities
Change from Stroke upper limb capacity scale (SULCS) at 8 weeks
UL Assessment - Activities
Change from Box & Block test at 4 weeks
UL Assessment - Activities
Change from Box & Block test at 8 weeks
UL Assessment - Activities

Full Information

First Posted
September 4, 2020
Last Updated
February 10, 2021
Sponsor
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04584177
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm-hand BOOST + Control
Arm Type
Experimental
Arm Description
First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program
Arm Title
Control + Arm-hand BOOST
Arm Type
Experimental
Arm Description
First 4 weeks control program, afterwards 4 weeks arm-hand boost program
Intervention Type
Behavioral
Intervention Name(s)
Arm-hand BOOST program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control program
Intervention Description
A dose-matched program of strengthening exercises for the lower limbs and general reconditioning
Primary Outcome Measure Information:
Title
Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks
Description
UL assessment - Function
Time Frame
Between baseline and first 4 weeks of study
Title
Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks
Description
UL assessment - Function
Time Frame
Between baseline and end of study (=8 weeks)
Title
Change from Action Research Arm Test at 4 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and first 4 weeks of study
Title
Change from Action Research Arm Test at 8 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and end of study (=8 weeks)
Secondary Outcome Measure Information:
Title
Change from Jebsen Taylor hand function test at 4 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and first 4 weeks of study
Title
Change from Jebsen Taylor hand function test at 8 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and end of study (=8 weeks)
Title
Change from Rivermead Motor Assessment Arm function at 4 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and first 4 weeks of study
Title
Change from Rivermead Motor Assessment Arm function at 8 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and end of study (=8 weeks)
Title
Change from Stroke upper limb capacity scale (SULCS) at 4 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and first 4 weeks of study
Title
Change from Stroke upper limb capacity scale (SULCS) at 8 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and end of study (=8 weeks)
Title
Change from Box & Block test at 4 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and first 4 weeks of study
Title
Change from Box & Block test at 8 weeks
Description
UL Assessment - Activities
Time Frame
Between baseline and end of study (=8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Meyer, PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital, Campus Sint-Ursula
City
Herk-de-Stad
ZIP/Postal Code
3540
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33716948
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.
Results Reference
derived

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Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

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