Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis (The REACH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- quickDASH
研究概览
简要总结
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.
详细描述
The specific aims of this study are to:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to use home exercise app, etc.)
结局指标
主要结局
quickDASH
时间窗: Change from Baseline at 8 weeks and 18 weeks
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.
次要结局
- Physical Function(Change from Baseline at 8 weeks and 18 weeks)
- Total Hand Function(Change from Baseline at 8 weeks and 18 weeks)
研究者
Susan Murphy
Associate Professor
University of Michigan