Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

NCT02837549 | Completed

• 1 other identifier: HUM00117117
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Ssc

Outcome Measures

Primary Outcomes (1)

• quickDASH

  self-report questionnaire of physical function and symptoms

  change over 8 weeks

Secondary Outcomes (4)

• Upper extremity range of motion

  change over 8 weeks

• Coordination

  change over 8 weeks

• Grip Strength

  change over 8 weeks

• Physical Function

  change over 8 weeks

Study Arms (1)

Occupational therapy treatment

EXPERIMENTAL

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

Interventions

Occupational therapy treatment OTHER

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

Also known as: Upper Extremity Rehabilitation

Occupational therapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• active hand ulcers

Sponsors & Collaborators

• University of Michigan: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1002/acr.23522.

  PMID: 29381834 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Susan Murphy, ScD

  University of Michigan - Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 19, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)