Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837549
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Susan Murphy, University of Michigan

Brief Summary:
The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.

Condition or disease Intervention/treatment Phase
Scleroderma Ssc Other: Occupational therapy treatment Not Applicable

Detailed Description:

Our specific aims are to:

  1. Determine the feasibility of a novel rehabilitation strategy provided at the University of Michigan Scleroderma Clinic to scleroderma patients who have upper extremity contractures.

    Investigators will assess 3 main aspects of the process that are key to the success of a larger study including the proportion of eligible people who enroll in the study, rate of adherence to the treatment protocol, and the time it takes to conduct sessions including treatment and outcome assessment completion. Based on a framework of recommendations for well-designed pilot studies [1], investigators have set the following criteria for success to examine these aspects:

    1. At least 50% of participants who are eligible for the study will enroll.
    2. At least 80% of participants will attend all treatment sessions.
    3. The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.
  2. Develop a standardized treatment manual to train therapists to provide this treatment to their patients.

    A standardized treatment manual for therapists is a critical component needed to ensure consistency in a larger multi-site trial. This manual will be drafted for use in this study and refined as needed.

  3. Establish preliminary effects of this 8-week rehabilitation program on improving arm function.

Investigators hypothesize that participants with scleroderma will have significant improvements in the QuickDASH disability measure at post test. Although the investigators think large effects will be shown, this study will allow us to determine estimates of the effects and the variability for power calculations in a multi-site trial.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
Study Start Date : July 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Experimental: Occupational therapy treatment

Participants will undergo the following 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 treatment
This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education
Other Name: Upper Extremity Rehabilitation




Primary Outcome Measures :
  1. quickDASH [ Time Frame: change over 8 weeks ]
    self-report questionnaire of physical function and symptoms


Secondary Outcome Measures :
  1. Upper extremity range of motion [ Time Frame: change over 8 weeks ]
    Active and Passive Range of Motion measured by goniometer

  2. Coordination [ Time Frame: change over 8 weeks ]
    9 hole peg test

  3. Grip Strength [ Time Frame: change over 8 weeks ]
    dynanometer

  4. Physical Function [ Time Frame: change over 8 weeks ]
    PROMIS physical function 8-item short form



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • diagnosis of scleroderma (localized or generalized morphea)
  • 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.
  • English speaking

Exclusion Criteria:

  • active hand ulcers

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): NCT02837549


Locations
Layout table for location information
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Susan Murphy, ScD University of Michigan - Department of Physical Medicine and Rehabilitation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Susan Murphy, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02837549    
Other Study ID Numbers: HUM00117117
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: upon written request
Additional relevant MeSH terms:
Layout table for MeSH terms
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases