SSc, Systemic Sclerosis
Conditions
Brief 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.
Interventions
OTHEROccupational 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.
OTHERHome app intervention
The app consists of videos depicting each exercise and ability to track adherence to exercises.
Sponsors
Scleroderma Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quickDASH | Change from Baseline at 8 weeks and 18 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | Change from Baseline at 8 weeks and 18 weeks | 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 |
| Total Hand Function | Change from Baseline at 8 weeks and 18 weeks | 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 |
Countries
United States
Outcome results
None listed