NCT01343602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

April 26, 2011

Last Update Submit

December 14, 2014

Conditions

Stroke

Keywords

strokeConstraint Induced Movement TherapyparticipationPhysical TherapyOccupational Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)

    3 and 6 months relative to baseline performance

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

    6 months relative to baseline performance

  • Nine-Hole Peg-Test

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

  • Stroke-Impact-Scale (SIS)

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

  • Barthel Index(BI)

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

  • +1 more secondary outcomes

Study Arms (2)

mod. Constraint-Induced Movement Therapy

EXPERIMENTAL

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

Therapy as usual

OTHER

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

Other: Therapy as usual

Interventions

mod. Constraint-Induced Movement TherapyBEHAVIORAL

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.

mod. Constraint-Induced Movement Therapy
Therapy as usualOTHER

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.

Therapy as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Related Publications (2)

  • 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.

    PMID: 26231624DERIVED

  • 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.

    PMID: 24124993DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne Barzel, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 28, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

DE(1)