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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Stroke

Treatments: Other: Therapy as usual; Behavioral: mod. Constraint-Induced Movement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01343602

BMBF-01-GX-1003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

mod. Constraint-Induced Movement Therapy

Experimental group

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.

Treatment:

Behavioral: mod. Constraint-Induced Movement Therapy

Therapy as usual

Other group

Description:

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

Treatment:

Other: Therapy as usual