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Completed

NCT Number: NCT03482219

Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Occupational Therapy

Other

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.

Home app intervention

Other

The app consists of videos depicting each exercise and ability to track adherence to exercises.

Primary outcomes

  1. quickDASH

    Time frame: 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 outcomes

  1. Physical Function

    Time frame: 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

  2. Total Hand Function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Scleroderma Foundation

Registry information

Official study title

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

Acronym: REACH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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