A Paradigm Sift: Rehabilitation Robotics, Cognitive Skills Training and Function
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 6 weeks
研究概览
简要总结
This study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.
详细描述
Research has shown that robot-assisted therapy can help people regain control of simple reaching or grasping movements, but these improvements don't generalize well to use of the weaker limb during everyday tasks.
This study aims to refine and test a protocol named the Active Learning Program for Stroke (ALPS), which teaches people to use active problem solving strategies and a home program to improve function. Therapist-delivered ALPS instruction may incorporate use of strategies (e.g. STOP, THINK, DO, CHECK) modeled after the Cognitive Orientation for daily Occupational Performance (CO-OP) approach to improve real-world use of the paretic upper limb. We will evaluate whether the combination of robot-assisted therapy and ALPS training leads to better satisfaction and functional use of the weaker arm in persons with motor impairments more than 6 months after stroke, as compared to robot-assisted therapy alone.
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)
盲法说明
Evaluator(s) will be blinded to assigned study group and intervention.
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
- •Diagnosed with unilateral stroke more than 6 months prior to study enrollment.
- •Stroke type will include both ischemic and hemorrhagic stroke.
- •Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60)
- •Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)during the 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, as indicated by subtests of the Fugl-Meyer Assessment (FMA) [13]
- •Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale [15];
- •Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test [16]
- •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
- •Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study
- •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 Motor Activity Log (MAL) Quality of Movement (QOM) at 6 weeks
时间窗: Baseline and 6 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks
时间窗: Baseline and 6 weeks
The Fugl-Meyer Assessment (FMA) will examine changes in motor function in the paretic upper extremity (UE) during basic reaching and grasping motions. All items are rated by a 3-point ordinal scale (0=cannot perform; 2=performs fully) with a total possible score of 60 points (reflex items will not be administered). Higher scores indicate better performance.
Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 10 weeks
时间窗: Baseline and 10 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 6 weeks
时间窗: Baseline and 6 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
Change from Baseline Fugl-Meyer Assessment (FMA) at 10 weeks
时间窗: Baseline and 10 weeks
The Fugl-Meyer Assessment (FMA) will examine changes in motor function in the paretic upper extremity (UE) during basic reaching and grasping motions. All items are rated by a 3-point ordinal scale (0=cannot perform; 2=performs fully) with a total possible score of 60 points (reflex items will not be administered). Higher scores indicate better performance.
Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 10 weeks
时间窗: Baseline and 10 weeks
The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.
次要结局
- Change from Baseline Home-based Accelerometry: Wearable Sensors at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Stroke Impact Scale (SIS) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) Time at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Modified Ashworth Scale (MAS) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Canadian Occupational Performance Measure (COPM) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Modified Ashworth Scale (MAS) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Canadian Occupational Performance Measure (COPM) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Stroke Impact Scale (SIS) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) Time at 10 weeks(Baseline and 10 weeks)
- Change from Baseline Home-based Accelerometry: Wearable Sensors at 10 weeks(Baseline and 10 weeks)
研究者
Susan Fasoli, ScD OTR/L
Associate Professor, MGH Institute of Health Professions
Spaulding Rehabilitation Hospital