Clinical trial NCT01343602: Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT)
Official title: Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Constraint Induced Movement Therapy
participation
Physical Therapy
Occupational Therapy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-04-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
timeFrame: 4 weeks (post-treatment) relative to baseline performance
Secondary outcomes:
measure: Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)
timeFrame: 3 and 6 months relative to baseline performance
measure: Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)
timeFrame: 6 months relative to baseline performance
measure: Nine-Hole Peg-Test
timeFrame: 4 weeks (post-treatment) and 6 months relative to baseline performance
measure: Stroke-Impact-Scale (SIS)
timeFrame: 4 weeks (post-treatment) and 6 months relative to baseline performance
measure: Barthel Index(BI)
timeFrame: 4 weeks (post-treatment) and 6 months relative to baseline performance
measure: Instrumental Activities of Daily Living Scale (IADL)
timeFrame: 4 weeks (post-treatment) and 6 months relative to baseline performance
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
name: Anne Barzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.