Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
Time Frame: 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 Outcomes
- Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)(3 and 6 months relative to baseline performance)
- Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)(6 months relative to baseline performance)
- Nine-Hole Peg-Test(4 weeks (post-treatment) and 6 months relative to baseline performance)
- Stroke-Impact-Scale (SIS)(4 weeks (post-treatment) and 6 months relative to baseline performance)
- Barthel Index(BI)(4 weeks (post-treatment) and 6 months relative to baseline performance)
- Instrumental Activities of Daily Living Scale (IADL)(4 weeks (post-treatment) and 6 months relative to baseline performance)