NCT01343602

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-04-28
• Last updated: 2014-12-16

Locations

1 site across 1 country: Germany