Functional Outcomes Following Task-based and VR Action Observation Interventions for Adults With Chronic Hemiparesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment (UE portion)
研究概览
简要总结
People with one arm that does not function well due to a stroke, head injury, or cerebral palsy, and a fully functional other arm, will be randomly assigned to receive one of the two interventions first, followed by the other intervention. The two interventions include a task-based intervention and a virtual reality intervention that provides a reflected image of the involved arm. The task-based intervention will consist of setting up activities of interest to be done using the involved arm and structuring practice and meaningful feedback to assist learning. The virtual reality intervention will consist of the person wearing the virtual reality device and practicing virtual tasks using the intact arm while seeing the involved arm. Intervention sessions will last approximately 30 minutes and will be held 3 times/week for 3 weeks each for a total of 9 sessions for each intervention. Testing of the involved arm's function will be done before the interventions, after receiving 9 sessions of each intervention, and one month after completing the second intervention received.
详细描述
Potential participants will be screened for age, history of stroke, brain injury, or cerebral palsy, and having one functional arm and one poorly functioning arm by phone. Those who meet the basic criteria will be scheduled for an Intake Evaluation consisting of obtaining voluntary informed consent, complete a demographic survey, visual field testing, cognitive screening, perceptual testing, and an arm/hand function test. Participants who meet the inclusion criteria will be scheduled for a Preliminary Evaluation.
The Preliminary Evaluation will measure the current motor control ability, perception of level of disability, and amount of active and passive motion in the involved arm.
Participants will participate in the first form of intervention (randomly assigned) for three 30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted during the Preliminary Evaluation with the addition of the arm/hand function test conducted during the initial screening.
Participants will participate in the second form of intervention for three 30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted following the first intervention.
One month after completing the second form of intervention, participants will be re-evaluated using the same tests used following the second intervention and will also receive a semi-structured interview regarding their thoughts and experiences during the study and their perceptions of the outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 89 years old
- •One arm not fully functional due to a stroke, brain injury, or cerebral palsy
- •More than 1 year since neurologic even that impaired arm function
排除标准
- •Cognitive impairment
- •visual field loss (homonymous hemianopsia)
- •perceptual deficits (MVPT4 lower than 2 standard deviations from the norm)
- •Seizure disorder
- •Currently receiving rehabilitation services (PT or OT) for the involved arm.
研究组 & 干预措施
Sequence #1
Participants will receive nine 30 minute sessions (over 3 weeks) of intervention A followed by nine 30 minute sessions (over 3 weeks) of intervention B.
干预措施: Virtual Reality (A) then Task (B) (Behavioral)
Sequence #2
Participants will receive nine 30 minute sessions (over 3 weeks) of intervention B followed by nine 30 minute sessions (over 3 weeks) of intervention B.
干预措施: Task (B) then Virtual Reality (A) (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer Assessment (UE portion)
时间窗: 1st week, 4 weeks, 8 weeks, 12 weeks
Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement
Change in Stroke Impact Scale 3.0
时间窗: 1st week, 4 weeks, 8 weeks, 12 weeks
Self-report health status measure; The Total Score and Subscale Scores range from 0 - 100 with higher scores indicating less perceived impact of the stroke on function and participation (positive change in scores indicate improvement)
Change in Box & Block Test
时间窗: 1st week, 4 weeks, 8 weeks, 12 weeks
Measures unilateral gross manual dexterity; a positive change in score indicates improvement
次要结局
- Change in Active and Passive Range of Motion(1st week, 4 weeks, 8 weeks, 12 weeks)
- Semi-structured interview(12 weeks)