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

Completed

Phase N/A Results N/A

Update History

17 Dec '14
The description was updated.
New
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.
Old
None.
A location was updated in Hamburg.
New
The overall status was removed for Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf.
25 Jan '12
A location was updated in Hamburg.
New
The overall status was updated to "Recruiting" at Institute of Primary Medical Care, University of Hamburg.
6 Oct '11
The eligibility criteria were updated.
New
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
Old
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