Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis

NCT03482219 | Completed

• 1 other identifier: HUM00141111
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis; SSc

Outcome Measures

Primary Outcomes (1)

• quickDASH

  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.

  Change from Baseline at 8 weeks and 18 weeks

Secondary Outcomes (2)

• Physical Function

  Change from Baseline at 8 weeks and 18 weeks

• Total Hand Function

  Change from Baseline at 8 weeks and 18 weeks

Study Arms (2)

Intensive treatment

EXPERIMENTAL

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; Other: Home app intervention

Home app intervention

ACTIVE COMPARATOR

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

Interventions

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.

Intensive treatment

Home app intervention OTHER

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

Home app intervention; Intensive treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to use home exercise app, etc.)

Sponsors & Collaborators

• University of Michigan: lead
• Scleroderma Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Murphy SL, Barber M, Huang S, Sabbagh M, Cutter G, Khanna D. Intensive and app-delivered occupational therapy to improve upper extremity function in early diffuse cutaneous systemic sclerosis: a pilot two-arm trial. Rheumatology (Oxford). 2021 Nov 3;60(11):5002-5011. doi: 10.1093/rheumatology/keab339.

  PMID: 33839775 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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 OTR

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: April 16, 2018
• Primary Completion: May 15, 2020
• Study Completion: September 26, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)