Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Medical Research Council Scale
研究概览
简要总结
This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.
详细描述
Background. The sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).
Methods. This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.
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
Initial and outcome assessments will be administered by a well-trained and certified occupational therapist who is blinded to the group assignment, study hypotheses, and intervention of the patients.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment [FMA] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score <3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score >24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies.
排除标准
- •The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.
研究组 & 干预措施
PRI group
The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The PRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist).
干预措施: Bi-Manu-Track (Device)
DRI group
The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The DRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).
干预措施: Bi-Manu-Track (Device)
结局指标
主要结局
Medical Research Council Scale
时间窗: Medical Research Council Scale will be administered to participants three months after intervention.
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Fugl-Meyer Assessment
时间窗: Fugl-Meyer Assessment will be administered to participants at three months after intervention.
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE. movement.
Fugl-Meyer Assessment
时间窗: Fugl-Meyer Assessment will be administered to participants at baseline.
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the upper extremity (UE) joints, and grasping, coordination, and speed of UE. movement.
Fugl-Meyer Assessment
时间窗: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE movement.
Medical Research Council Scale
时间窗: Medical Research Council Scale will be administered to participants at baseline.
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Medical Research Council Scale
时间窗: Medical Research Council Scale will be administered to participants immediately after intervention.
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
次要结局
- The Stroke Self-Efficacy Questionnaire(The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.)
- The Wolf Motor Function Test(The Wolf Motor Function Test will be administered to participants three months after intervention.)
- The Montreal Cognitive Assessment(The Montreal Cognitive Assessment will be administered to participants immediately after intervention.)
- The ABILHAND Questionnaire(The ABILHAND Questionnaire will be administered to participants three months after intervention..)
- The Stoke Impact Scale 3.0(The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.)
- The Chedoke Arm and Hand Activity Inventory(The Chedoke Arm and Hand Activity Inventory will be administered to participants three months after intervention.)
- The ABILHAND Questionnaire(The ABILHAND Questionnaire will be administered to participants at baseline.)
- The ABILHAND Questionnaire(The ABILHAND Questionnaire will be administered to participants immediately after intervention..)
- The Stoke Impact Scale 3.0(The Stoke Impact Scale 3.0 will be administered to participants at baseline.)
- The Stoke Impact Scale 3.0(The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.)
- The Stroke Self-Efficacy Questionnaire(The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.)
- The Stroke Self-Efficacy Questionnaire(The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.)
- The Wolf Motor Function Test(The Wolf Motor Function Test will be administered to participants at baseline.)
- The Wolf Motor Function Test(The Wolf Motor Function Test will be administered to participants immediately after intervention.)
- The Montreal Cognitive Assessment(The Montreal Cognitive Assessment will be administered to participants at baseline.)
- The Chedoke Arm and Hand Activity Inventory(The Chedoke Arm and Hand Activity Inventory will be administered to participants at baseline.)
- The Chedoke Arm and Hand Activity Inventory(The Chedoke Arm and Hand Activity Inventory will be administered to participants immediately after intervention.)