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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482219
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Scleroderma Foundation
Information provided by (Responsible Party):
Susan Murphy, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis SSc Other: Occupational therapy Other: Home app intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled clinical trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis (The REACH Study)
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive treatment

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
Other: Occupational 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.

Other: Home app intervention
The app consists of videos depicting each exercise and ability to track adherence to exercises.

Active Comparator: Home app intervention
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
The app consists of videos depicting each exercise and ability to track adherence to exercises.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482219


Contacts
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Contact: Susan Murphy, ScD OTR 7343019376 sumurphy@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Susan Murphy    734-763-3435    sumurphy@umich.edu   
Principal Investigator: Susan L Murphy, ScD, OTR         
Sponsors and Collaborators
University of Michigan
Scleroderma Foundation
Investigators
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Principal Investigator: Susan Murphy, ScD OTR Associate Professor

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Responsible Party: Susan Murphy, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03482219    
Other Study ID Numbers: HUM00141111
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases