Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT)

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: mod. Constraint-Induced Movement Therapy; Other: Therapy as usual

• Registration Number: NCT01343602
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.

Detailed Description

The study is a parallel cluster randomized controlled trial with therapy practices as clusters. After written consent from the patients, the therapists are randomly assigned to treat either the intervention or the control group. Blinded external assessors evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are quality of arm and hand use and arm and hand function. Assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes are analyzed with mixed models, which consider the hierarchical structure of the data, adjusted to the baseline measurements and sex. The primary analysis compares the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints are tested at the significance level of 5% each in hierarchical order.

Study Timeline

• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Study Start: 2011-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-14
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• age ≥ 18 years
• Stroke onset > 6 months prior to study enrollment
• upper extremity hemiparesis with impairment of hand and/or arm
• minimal function of the hand (at least 10º active wrist extension, at least 10º active of thumb abduction/extension, and at least 10º of extension two additional fingers)
• non-professional coach (e.g. family member)
• prescription of physical or occupational therapy

Exclusion Criteria

• lack of knowledge of German
• serious impairment of verbal communication ability (e.g. severe aphasia)
• inability to consent (e.g. dementia)
• severe neuro-cognitive deficits (MMSE <23)
• terminal illness, life-threatening co-morbidity
• simultaneous participation in another treatment study targeting stroke recovery
• subjects may not have already received constraint induced movement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mod. Constraint-Induced Movement Therapy	mod. Constraint-Induced Movement Therapy	CIMT at home is applied in the patients' home over the course of four weeks including (i.e. 20 consecutive days) 2 hours of daily training together with an instructed non-professional coach (e.g. family member) applying shaping techniques.
Therapy as usual	Therapy as usual	Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).

Primary Outcome Measures

Name	Time	Method
Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)	4 weeks (post-treatment) relative to baseline performance	"Participation" defined as equal involvement in all aspects of society and daily living for people with disabilities is a composite outcome of the following two measures: The MAL-QOM is a self-administered measure of how well 30 daily activities are performed to assess the change in the quality of arm and hand use and the WMFT-PT, measured as the average time (in seconds) to complete 15 tasks, to evaluate the change in arm and hand function.

Secondary Outcome Measures

Name	Time	Method
Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)	3 and 6 months relative to baseline performance	to assess the change in the quality and amount of arm and hand use
Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)	6 months relative to baseline performance	to assess the change in time and quality of movement
Nine-Hole Peg-Test	4 weeks (post-treatment) and 6 months relative to baseline performance	to assess finger dexterity
Stroke-Impact-Scale (SIS)	4 weeks (post-treatment) and 6 months relative to baseline performance	to assess the impact on health and quality of life. A self-administered 59-item questionnaire, which assesses 8 domains of stroke (Strength, Hand Function, Activities of Daily Living / Instrumental Activities of Daily Living, Mobility, Communication, Emotion, Memory and Thinking, and Participation)
Barthel Index(BI)	4 weeks (post-treatment) and 6 months relative to baseline performance	to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)
Instrumental Activities of Daily Living Scale (IADL)	4 weeks (post-treatment) and 6 months relative to baseline performance	to asses self-maintaining and instrumental activities of daily living

Trial Locations

Locations (1)

Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany