Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Bilateral Activity Monitors (Accelerometers)
研究概览
简要总结
Participants will receive intensive therapy through a video game in their own homes for 1 month. The game is operated by movements of the body (no controller needed) and acts like a virtual therapist. Participants will agree to play the game for 30 hours. They will also receive 4 home visits from a therapist designed to increase use of their arm for daily activities that are important to them. Participants will also receive a smart watch that will measure use of their weaker arm and alert them when their arm is not participating in activities. Arm strength and function will be measured before and after the therapy program.
详细描述
Randomized waitlist control trial. One group will receive treatment immediately (50%) and the other group will receive treatment following a three-week delay (50%). Group 1 will be assessed by physical/occupational therapists and rehabilitation psychologists (blinded to treatment phase) before and after the virtual gaming treatment. Group 2 will receive two baseline assessments (baseline followed by three weeks of usual and customary care and then another baseline before starting the gaming treatment), and again after three weeks of virtual gaming treatment.
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 (Outcomes Assessor)
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
- •Patients who have progressive multiple sclerosis resulting in upper extremity motor impairment.
- •Have the ability to comprehend and participate in basic elements of the therapy.
- •Have substantial non-use in the more affected upper extremity.
排除标准
- •Are currently participating in other experimental trials.
- •Are currently participating in additional upper extremity therapy.
- •Experienced relapse within the past 6 months.
- •Too frail to undergo intensive rehabilitation,
- •Those with serious, uncontrolled medical problems.
研究组 & 干预措施
Immediate Treatment
Patients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention.
The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains.
干预措施: Gaming CI Therapy (Behavioral)
Delayed Treatment
Patients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention.
The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains.
干预措施: Gaming CI Therapy (Behavioral)
结局指标
主要结局
Bilateral Activity Monitors (Accelerometers)
时间窗: 0 to 1 Months
Devices to monitor upper extremity movement throughout treatment
Wolf Motor Function Test
时间窗: 0 to 1 Months
Assessment to evaluate motor function
次要结局
- Biomechanical Measures(0 to 1 Months)
- Multiple Sclerosis Impact Scale (MSIS-29)(0 to 1 Months)
- Short form-36 Health Survey(0 to 1 Months)
- Neuro-QOL(0 to 1 Months)
- Patient Health Questionnaire (PHQ-9)(0 to 1 Months)
- Montreal Cognitive Assessment (MoCA)(0 to 1 Months)
研究者
Lynne Gauthier
Associate Professor of Physical Therapy and Kinesiology
University of Massachusetts, Lowell