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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01343602
First received: April 26, 2011
Last updated: December 14, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Stroke
Behavioral: mod. Constraint-Induced Movement Therapy
Other: Therapy as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT) [ Time Frame: 4 weeks (post-treatment) relative to baseline performance ] [ Designated as safety issue: No ]
    "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.


Secondary Outcome Measures:
  • Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU) [ Time Frame: 3 and 6 months relative to baseline performance ] [ Designated as safety issue: No ]
    to assess the change in the quality and amount of arm and hand use

  • Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA) [ Time Frame: 6 months relative to baseline performance ] [ Designated as safety issue: No ]
    to assess the change in time and quality of movement

  • Nine-Hole Peg-Test [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ] [ Designated as safety issue: No ]
    to assess finger dexterity

  • Stroke-Impact-Scale (SIS) [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ] [ Designated as safety issue: No ]
    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)

  • Barthel Index(BI) [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ] [ Designated as safety issue: No ]
    to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)

  • Instrumental Activities of Daily Living Scale (IADL) [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ] [ Designated as safety issue: No ]
    to asses self-maintaining and instrumental activities of daily living


Enrollment: 156
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Therapy as usual
Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343602

Locations
Germany
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Anne Barzel, MD Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01343602     History of Changes
Other Study ID Numbers: BMBF-01-GX-1003
Study First Received: April 26, 2011
Last Updated: December 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stroke
Constraint Induced Movement Therapy
participation
Physical Therapy
Occupational Therapy

ClinicalTrials.gov processed this record on March 26, 2015