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

NCT ID: NCT01343602

Last Updated: 2014-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Stroke

Keywords

stroke; Constraint Induced Movement Therapy; participation; Physical Therapy; Occupational Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

mod. Constraint-Induced Movement Therapy

Intervention Type: BEHAVIORAL

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.

Therapy as usual

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

Group Type: OTHER

Therapy as usual

Intervention Type: OTHER

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.

Interventions

mod. Constraint-Induced Movement Therapy

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.

Intervention Type: BEHAVIORAL

Therapy as usual

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Barzel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

Locations

Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

Barzel A, Ketels G, Stark A, Tetzlaff B, Daubmann A, Wegscheider K, van den Bussche H, Scherer M. Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial. Lancet Neurol. 2015 Sep;14(9):893-902. doi: 10.1016/S1474-4422(15)00147-7. Epub 2015 Jul 28.

Reference Type: DERIVED

PMID: 26231624 (View on PubMed)

Barzel A, Ketels G, Tetzlaff B, Kruger H, Haevernick K, Daubmann A, Wegscheider K, Scherer M. Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 14;14:334. doi: 10.1186/1745-6215-14-334.

Reference Type: DERIVED

PMID: 24124993 (View on PubMed)

Other Identifiers

BMBF-01-GX-1003

Identifier Type: -

Identifier Source: org_study_id