Clinical trial NCT03482219: Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis
Official title: Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis (The REACH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
SSc
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Scleroderma Foundation
First posted: 2018-03-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: quickDASH
timeFrame: Change from Baseline at 8 weeks and 18 weeks
Secondary outcomes:
measure: Physical Function
timeFrame: Change from Baseline at 8 weeks and 18 weeks
measure: Total Hand Function
timeFrame: Change from Baseline at 8 weeks and 18 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor
name: Susan Murphy, ScD OTR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.