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Completed

NCT Number: NCT01343602

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mod. Constraint-Induced Movement Therapy

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

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.

Primary outcomes

  1. 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

    "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 outcomes

  1. 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

    to assess the change in the quality and amount of arm and hand use

  2. Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)

    Time frame: 6 months relative to baseline performance

    to assess the change in time and quality of movement

  3. Nine-Hole Peg-Test

    Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance

    to assess finger dexterity

  4. Stroke-Impact-Scale (SIS)

    Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance

    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)

  5. Barthel Index(BI)

    Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance

    to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)

  6. Instrumental Activities of Daily Living Scale (IADL)

    Time frame: 4 weeks (post-treatment) and 6 months relative to baseline performance

    to asses self-maintaining and instrumental activities of daily living

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: HOMECIMT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 28, 2011
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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