Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis



Status:Recruiting
Conditions:Neurology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:April 16, 2018
End Date:March 31, 2020
Contact:Susan Murphy, ScD OTR
Email:sumurphy@umich.edu
Phone:7343019376

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

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.

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.

Inclusion Criteria:

- Have a diagnosis of systemic sclerosis including:

- Diffuse cutaneous subset

- Disease duration < 5 years from 1st non Raynaud phenomenon sign or symptom

- Have a contracture of the hand and other joint in at least one arm, such as wrist,
elbow, or shoulder, with the ability to demonstrate active range of motion in that arm

- Willing to travel to participate in therapy and outcome assessments.

- Have an Android, iPhone, iPad or computer tablet to load the home exercise App.

- English speaking

Exclusion Criteria:

- issues that preclude meaningful participation in study procedures (e.g. concurrent or
complex medical issues, inability to use home exercise app, etc.)
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Susan L Murphy, ScD, OTR
Phone: 734-763-3435
University of Michigan The University of Michigan was founded in 1817 as one of the...
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from
Ann Arbor, MI
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