Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis

Study Overview
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Brief Summary
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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
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The specific aims of this study are to: 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. 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.

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

Conditions
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Systemic Sclerosis, SSc

Intervention / Treatment
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* Other: Occupational therapy
* Other: Home app intervention


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive treatment<br>Participants will undergo 8 sessions with an occupational therapist. Participants will meet with the occupational therapist to establish the home exercise program and set up the home exercise app. The app has videos depicting each exercise and ability to track adherence to exercises. The occupational therapy consists of the following which will be provided as appropriate: Thermal Modalities Hot packs, focused on areas with limitations Paraffin, focused on digital limitations Application of the Physiotouch (a low-intensity negative pressure device) Passive Range of Motion Active Range of Motion Functional Activities | Other: Occupational therapy<br>* 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.<br>Other: Home app intervention<br>* The app consists of videos depicting each exercise and ability to track adherence to exercises.<br>|
| Active Comparator: Home app intervention<br>Participants will meet with the occupational therapist to establish the home exercise program and set up the home exercise app. The app has videos depicting each exercise and ability to track adherence to exercises. | Other: Home app intervention<br>* The app consists of videos depicting each exercise and ability to track adherence to exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline at 8 weeks and 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Change from Baseline at 8 weeks and 18 weeks |