Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482219
• Other study ID #: HUM00141111
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: September 26, 2020

Study information

• Verified date: September 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 26, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• SSc
• Systemic Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Scleroderma Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical Function	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	Change from Baseline at 8 weeks and 18 weeks
Secondary	Total Hand Function	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	Change from Baseline at 8 weeks and 18 weeks