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

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ClinicalTrials.gov Identifier: NCT01343602
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE April 26, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date December 16, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • 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
  • 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
  • Nine-Hole Peg-Test [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ]
    to assess finger dexterity
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • 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
  • 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
  • Nine-Hole Peg-Test [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ]
    to assess finger dexterity
  • 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)
  • Functional Independence Measure (FIM) [ Time Frame: 4 weeks (post-treatment) and 6 months relative to baseline performance ]
    for assessing the degree of whole-person disability, particularly judging the extent of recovery from stroke.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT)
Official Title  ICMJE Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: mod. Constraint-Induced Movement Therapy
  • Therapy as usual
    Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).
    Intervention: Other: Therapy as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2014)
156
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2011)
180
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343602
Other Study ID Numbers  ICMJE BMBF-01-GX-1003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Anne Barzel, MD Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP