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

Stroke Clinical Trial

— HOMECIMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343602
• Other study ID #: BMBF-01-GX-1003
• Status: Completed
• Phase: N/A
• First received: April 26, 2011
• Last updated: December 14, 2014
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Germany	Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)	"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.	4 weeks (post-treatment) relative to baseline performance	No
Secondary	Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)	to assess the change in the quality and amount of arm and hand use	3 and 6 months relative to baseline performance	No
Secondary	Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)	to assess the change in time and quality of movement	6 months relative to baseline performance	No
Secondary	Nine-Hole Peg-Test	to assess finger dexterity	4 weeks (post-treatment) and 6 months relative to baseline performance	No
Secondary	Stroke-Impact-Scale (SIS)	to assess the impact on health and quality of life. A self-administered 59-item questionnaire, which assesses 8 domains of stroke (Strength, Hand Function, Activities of Daily Living / Instrumental Activities of Daily Living, Mobility, Communication, Emotion, Memory and Thinking, and Participation)	4 weeks (post-treatment) and 6 months relative to baseline performance	No
Secondary	Barthel Index(BI)	to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)	4 weeks (post-treatment) and 6 months relative to baseline performance	No
Secondary	Instrumental Activities of Daily Living Scale (IADL)	to asses self-maintaining and instrumental activities of daily living	4 weeks (post-treatment) and 6 months relative to baseline performance	No