Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)

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

Sponsors

Lead sponsor: Universitätsklinikum Hamburg-Eppendorf

Collaborator: German Federal Ministry of Education and Research

Source 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.

Overall Status Completed
Start Date October 2011
Completion Date June 2013
Primary Completion Date June 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
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
Enrollment 156
Condition
Intervention

Intervention type: Behavioral

Intervention name: mod. Constraint-Induced Movement Therapy

Description: Therapists of the intervention group are trained in "CIMT at home". During an initial home visit the therapist determines together with the patient an individually tailored home training program focussing on everyday practice and instructs the non-professional coach. For four weeks the patients will perform 2 hours of daily training at home together with an instructed non-professional coach (e.g. family member) applying shaping techniques (i.e. 20 consecutive days). Patients are supposed to wear a resting hand splint for the entire treatment period for 4 to 6 hours daily. During the four weeks the therapist will provide 5 weekly visits at the patients' home to instruct and supervise the training.

Arm group label: mod. Constraint-Induced Movement Therapy

Intervention type: Other

Intervention name: Therapy as usual

Description: Therapy as usual consists of the therapy, which is usually provided by the occupational or physical therapist. Therapy will be applied at the patients home or at the therapists' practice.

Arm group label: Therapy as usual

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Anne Barzel, MD Principal Investigator Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
Location
facility
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
Location Countries

Germany

Verification Date

December 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: mod. Constraint-Induced Movement Therapy

Arm group type: Experimental

Description: 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.

Arm group label: Therapy as usual

Arm group type: Other

Description: Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).

Acronym HOMECIMT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov