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

University of Michigan

Status: Completed

Conditions: Systemic Sclerosis; SSc

Treatments: Other: Occupational therapy; Other: Home app intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03482219

HUM00141111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Intensive treatment

Experimental group

Description:

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: 1. Thermal Modalities Hot packs, focused on areas with limitations Paraffin, focused on digital limitations 2. Application of the Physiotouch (a low-intensity negative pressure device) 3. Passive Range of Motion 4. Active Range of Motion 5. Functional Activities

Treatment:

Other: Home app intervention

Other: Occupational therapy

Home app intervention

Active Comparator group

Description:

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.

Treatment:

Other: Home app intervention