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Completed

NCT Number: NCT02837549

Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

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.

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Ssc

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

Our specific aims are to:

  • 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:

  • At least 50% of participants who are eligible for the study will enroll.
  • At least 80% of participants will attend all treatment sessions.
  • The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.
  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Occupational Therapy Treatment

Other

This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education

Other names: Upper Extremity Rehabilitation

Primary outcomes

  1. quickDASH

    Time frame: change over 8 weeks

    self-report questionnaire of physical function and symptoms

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • University of Alabama at Birmingham

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Oct 26, 2017

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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