NCT03482219

Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Systemic Sclerosis
• SSc

Interventions

Type	Name	Description
OTHER	Occupational therapy	The Occupational therapy intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education. The home app intervention involves one session of education with the occupational therapist.
OTHER	Home app intervention	The app consists of videos depicting each exercise and ability to track adherence to exercises.

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-05-15
• Completion: 2020-09-26
• First posted: 2018-03-29
• Last updated: 2020-09-29

Locations

1 site across 1 country: United States