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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Modified Constraint-Induced Movement Therapy Behavioral
    Intervention Desc: Physiotherapists and occupational therapists of the intervention group are trained in the modified therapy approach "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: on weekends no training is required). 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 weekly visits at the patients' home to instruct and supervise the training (in total 5, corresponding to 10 treatment units).
    ARM 1: Kind: Experimental
    Label: Modified Constraint-Induced Movement Therapy
  • Therapy as usual Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual and Customary Care
    ARM 2: Kind: Experimental
    Label: Therapy as usual
    Description: Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).
  • Mod. Constraint-Induced Movement Therapy Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: mod. Constraint-Induced Movement Therapy
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT) 4 weeks (post-treatment) relative to baseline performance No
Secondary Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU) 3 and 6 months relative to baseline performance No
Secondary Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA) 6 months relative to baseline performance No
Secondary Nine-Hole Peg-Test 4 weeks (post-treatment) and 6 months relative to baseline performance No
Secondary Stroke-Impact-Scale (SIS) 4 weeks (post-treatment) and 6 months relative to baseline performance No
Secondary Functional Independence Measure (FIM) 4 weeks (post-treatment) and 6 months relative to baseline performance No
Secondary Barthel Index(BI) 4 weeks (post-treatment) and 6 months relative to baseline performance No
Secondary Instrumental Activities of Daily Living Scale (IADL) 4 weeks (post-treatment) and 6 months relative to baseline performance No

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