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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
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.
The app consists of videos depicting each exercise and ability to track adherence to exercises.
University of Michigan
Ann Arbor, Michigan, United States
quickDASH
self-report questionnaire of physical function and symptoms. This is an 11-item questionnaire in which difficulty in several tasks involving the upper extremity are rated as well as interference and severity of symptoms. Items are averaged and converted to a 0 - 100 scale; a higher score indicates worse function.
Time frame: Change from Baseline at 8 weeks and 18 weeks
Physical Function
PROMIS physical function 8-item short form. The US population mean score for this measure is 50 with SD of 10, and a higher score denotes better function
Time frame: Change from Baseline at 8 weeks and 18 weeks
Total Hand Function
Summary score of degrees of active range of motion in hand. This is calculated by summing the total active range of motion for each finger and thumb by goniometer (260 degrees in each finger and 135 in the thumb). A total score of 1125 is possible and a higher score equals more range of motion
Time frame: Change from Baseline at 8 weeks and 18 weeks
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