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Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis — REACH  

Systemic Sclerosis Clinical Trial

Official title:
Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis (The REACH Study)

Clinical Trial Summary

The purpose of this study is to test two rehabilitation programs to improve arm function for patients with scleroderma. This is a Phase 2 randomized controlled trial in which participants will be assessed at baseline, 8 weeks, and 18 weeks. Participants will be randomized into an intensive intervention (8 individual sessions of occupational therapy plus a home exercise app) versus a home app treatment alone. The results of this study will be used to design a large multi-site trial in which optimized rehabilitation strategies can be used to help patients improve their arm function.

Clinical Trial Description

The specific aims of this study are to:

1. Determine the short and longer-term effects of an intensive (8-week in-person occupational therapy treatment with prescribed home exercises) on improving arm function versus home exercise alone.

This study's hypothesis is that immediately following treatment at 8 weeks and at 18 weeks, participants randomized to the in-person occupational therapy will have significant improvements in the QuickDASH disability measure, PROMIS physical function measure, and total active hand function compared to the home exercise alone.

2. Determine how adherence to home exercise in both groups influences treatment effects.

This study's hypothesis is that adherence will independently predict improvement in outcomes at 8 and 18 weeks regardless of treatment group assignment and that higher adherence to the home exercise program will result in greater and more long-lasting improvements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03482219
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date April 16, 2018
Completion date September 26, 2020
View Details
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