Infusing Robot-Assisted Therapy With Motor Learning Principles: An Active Learning Program for Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change From Baseline in Wolf Motor Function Test (WMFT)
研究概览
简要总结
Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. Rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. The purpose of this pilot study is to develop and test a therapy called the "Active Learning Program for Stroke" (ALPS). We are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.
详细描述
Little is known about how individuals learn to utilize robot-trained movements during upper extremity (UE) activities in the home and community and whether specific instruction can enhance motor learning and carry-over.. Systematic reviews of robot-assisted therapy for the paretic UE confirm gains in motor capacity as measured by clinical assessments, but provide little evidence of improved UE performance during daily tasks and occupations. These findings may be attributed to the limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity of practice with little regard for other principles of motor learning and experience-dependent neuroplasticity. These principles, including the salience of training tasks, transfer of acquired skills to similar activities, and active engagement and problem solving, are key to task-oriented training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well integrated into robot-assisted therapy protocols. The transfer of robot-trained movements to UE activities within the home and community needs further exploration before widespread use in rehabilitation practice is expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind study.
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow & hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
- •Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)12 during initial evaluation visit
排除标准
- •No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy
- •Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
- •Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
- •Aphasia sufficient to limit comprehension and completion of the treatment protocol
- •Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
- •Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
结局指标
主要结局
Change From Baseline in Wolf Motor Function Test (WMFT)
时间窗: Baseline and 1-month follow-up
The WMFT examined changes in ability to complete timed, functionally-based activities with the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The task rate was calculated as the average # of times that each test item could be completed within 1 minute. Here we report the change in task rate scores between admission and 1 month follow-up assessments to reflect retention of motor function following intervention. A higher number indicates improved task completion.
Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale
时间窗: Baseline and 1-month follow-up
The CAHM is a self-report assessment in which participants are asked to rate their confidence (0-100%) in successfully using their paretic UE for a variety of everyday activities. Change in confidence ratings between baseline, post-intervention and 1-month follow up assessments were examined. A higher score indicates greater confidence. We report change scores between admission and 1 month follow up assessments to reflect retention of scores following intervention.
Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest
时间窗: Baseline and 1-month follow-up
The FMA will examine changes in motor function, pain and sensation in the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The FMA upper extremity subtest contains 33 items, scored as 0= unable, 1=partial ability, 2= faultless with a total possible score of 66 points. Change was calculated as the value at the 1 month follow-up assessment minus the value at baseline to reflect retention of motor function following intervention.
次要结局
- Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale(Baseline and 1-month follow-up)
- Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale(Baseline and 1-month follow-up)
- Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task(Baseline and immediately after 6-week intervention)
- Change From Baseline on Modified Ashworth Scale (MAS)(Baseline and 1-month follow-up)
- Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain(Baseline and 1-month follow-up)
- Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery(Baseline and 1-month follow-up)
- Change From Baseline in Movement Time During Reach-to-Target Task(Baseline and immediately after 6-week intervention)
研究者
Susan Fasoli, ScD OTR/L
Associate Professor, MGH Institute of Health Professions
Spaulding Rehabilitation Hospital