The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
研究概览
简要总结
The objective of this pilot randomized controlled single blinded, parallel-group study is to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired stroke survivors.
详细描述
The current proposal aims to conduct a pilot randomized controlled single blinded, parallel-group study design to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb (UL) motor impairment outcomes in the chronic, moderately impaired stroke survivor. Individuals will be randomized to 1) experimental conditions of AO + RTP practice schedule, or 2) control condition of Placebo Video (PV) + RTP, and will receive an assigned regimen from a blinded intervention therapist for one hour, 3 times per week, for 8 weeks (total of 24 sessions), and a daily 30 minute HEP. A blinded assessor will complete assessments on each subject at three distinct time points of pretest, post intervention, and 1 month post intervention.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
The care provider completing intervention and the outcomes assessor are members of the research team and blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced a stroke resulting in a Upper Extremity Fugl Meyer score >17 < 49
- •Experienced a post stroke > 6 months
- •> 24 on the Folstein Mini Mental Status Examination
- •Experienced only one stroke
- •Discharged from all forms of physical rehabilitation intervention
- •Visual acuity of 20/50 or greater with or without corrective lenses
- •> 19 on the Hooper Visual Organization Test
- •Unilateral stroke only
- •Cerebral stroke
- •Age of onset of stroke greater than 18 years old.
排除标准
- •< 18 years old
- •> 5 on a 10-point visual analog pain scale in the affected UL
- •> 2 on the Modified Ashworth Scale in the affected UL to exclude individuals with hypertonia, spasticity, joint rigidity, and joint contracture
- •Participating in any experimental rehabilitation or drug studies
- •Uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
- •Neurological disorder other than stroke
- •> 31 on Beck Depression Inventory ("Severe Depression")
- •Unable to regularly attend treatment sessions and follow-up due to distance from the center or inadequate social support
- •Cerebellar stroke with ataxia
研究组 & 干预措施
Action Observation + Repetitive Task Practice
Action Observation (AO) therapy regimen will include watching a 6 minute video of another person completing a specified functional task (Putting on a shirt, pick up a sandwich and bring to mouth, eat food with a spoon, or cut meat with knife and fork). Subjects will be instructed to carefully watch the AO video and prepare to physically perform the task immediately after observing the video. The Repetitive Task Practice (RTP) therapy regimen emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task that is matched to the AO recording. The AO + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions.
干预措施: Action Observation + Repetitive Task Practice (Behavioral)
Placebo Video + Repetitive Task Practice
The control placebo videos (PV) will be 6 minutes, and will include a series of changing static images without animals, human beings, or sound (i.e. pictures of buildings, trees, cruise ships, mountains, beach umbrellas, beds, and tables). A Repetitive Task Practice (RTP) therapy regimen will be completed immediately after observing the PV, which emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task. These tasks include putting on a shirt, picking up a sandwich and bringing it to mouth, eating food with a spoon, or cutting meat with knife and fork. The PV + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions.
干预措施: Placebo Video + Repetitive Task Practice (Behavioral)
结局指标
主要结局
Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
时间窗: Pretest, immediately after the intervention, and 1 month post intervention
Assessment to evaluate motor impairment of the hemiplegic upper limb. Multiple time points will be used to asses the change in motor impairment. Items are scored on a 3 point ordinal scale (0 = cannot perform, 2 = can perform fully), and are totaled for a maximum of 66 possible points.
次要结局
- Change from baseline in smoothness of movements measured by three-axis accelerometer(Each session (3 times per week) during 8 week intervention)
- Change from Baseline in Stroke Impact Scale 2.0(Pretest, immediately after the intervention, and 1 month post intervention)
- Change from Baseline in the The Arm Motor Ability Test(Pretest, immediately after the intervention, and 1 month post intervention)
- Daily Diary(Each day during 8 week intervention)
- Change in Amount of physical assist to perform task(Each session (3 times per week) during 8 week intervention)
- Change from Baseline in the Motor Activity Log(Pretest, immediately after the intervention, and 1 month post intervention)
- Change in Movement time to complete task(Each session (3 times per week) during 8 week intervention)
- Survey to assess subjects experience in the study(immediately after the intervention, and 1 month post intervention)
- Number of trials/ repetitions per task(Each session (3 times per week) during 8 week intervention)
- Change in Number of verbal cues given to perform task(Each session (3 times per week) during 8 week intervention)
- Change in the number of errors during task performance(Each session (3 times per week) during 8 week intervention)
研究者
John Buford, PT, PhD
Professor and Director of Physical Therapy Division, School of Health and Rehabilitation Sciences
Ohio State University