A Novel Approach to Implementing Constraint-Induced Movement Therapy in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention
研究概览
简要总结
The goal of this clinical trial is to learn how a partially self-supervised constraint-induced movement therapy (sCIMT) program in adults with arm and hand weakness will work after stroke. This study will look at whether the program can help people improve the use of their arm and hand after a stroke while requiring less time with a therapist. The main questions it aims to answer are:
- Does the sCIMT program help people use their affected arm and hand better - after a stroke?
- Do participants feel that the sCIMT program is useful, easy to follow, and a good fit for their recovery needs?
- Does taking part in the sCIMT program improve participants' quality of life and daily well-being?
Participants will:
- Take part in a therapy program 5x/week for 2 weeks. The program is designed to help improve the use of the arm and hand affected by stroke.
- Wear a mitt on the stronger hand during certain practice activities to encourage use of the weaker hand.
- Complete surveys and tests before and after the program to measure arm and hand use, experiences with the program, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Sustained a first-time ischemic or hemorrhagic stroke ≥2 weeks prior to study enrollment
- •Age ≥18 and ≤85
- •Moderate UE hemiparesis as defined by a score ≥13 and ≤47 on the modified UE section of the Fugl-Meyer Assessment (60-point scale with no reflex testing)
- •Ability to actively extend impaired wrist ≥10 degrees
- •UE strength and active range of motion within functional limits on the non-hemiparetic side
- •Ability to follow two-step commands (visual or verbal) as determined by the clinical investigator
- •Nonuse of the more impaired UE as evidenced by an average score ≤2.5 on the Motor Activity Log Amount of Use Scale.
排除标准
- •Excessive pain in the affected shoulder, arm, or hand as measured by a score ≥6 on a 10-point visual analogue scale
- •Unable to passively reach neutral position for wrist extension and forearm supination
- •Excessive spasticity in the affected wrist or finger flexors/extensors and elbow flexors, as defined as a score of >2 on the Modified Ashworth Scale (MAS)
- •Inability to actively participate in regular therapy sessions (e.g., due to medical complexity, insufficient endurance, transportation, etc.) as determined by participant or by clinical judgement of the evaluating therapist
- •Receiving occupational therapy services for the hemiparetic UE during the two-week intervention window (including after pre-assessment and before post-assessment)
- •Received focal anti-spasticity drug injection (e.g., Botox) to any muscles of the impaired UE within the past 1 month (or plan to at some point during study enrollment)
- •Comorbid diagnosis in addition to stroke (e.g., dementia, peripheral neuropathy) that in the opinion of the investigator could impact study results
- •Presence of moderate to severe unilateral spatial neglect as indicated by clinical observation or failure on a standardized screening tool (e.g., Line Bisection Test or Bells Test).
结局指标
主要结局
Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention
时间窗: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
The Action Research Arm Test (ARAT) will be used to assess upper extremity motor function. The ARAT is a standardized performance-based measure consisting of 19 items that evaluate grasp, grip, pinch, and gross arm movement. Total scores range from 0 to 57, with higher scores indicating better upper extremity function. The primary outcome will be the change in ARAT score from baseline (pre-intervention) to post-intervention following completion of the self-supervised constraint-induced movement therapy (sCIMT) program.
Implementation of sCIMT (AIM, FIM, IAM Score)
时间窗: Post-intervention (within 1 week of completing the 2-week sCIMT program)
The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) comprise a standardized implementation outcomes instrument that evaluates participants' perceptions of an intervention's acceptability, appropriateness, and feasibility. The instrument consists of 12 items (4 items per domain), each rated on a 5-point Likert scale, with higher scores indicating greater perceived acceptability, appropriateness, and feasibility.
次要结局
- Recruitment Rate(Through completion of study enrollment, an average of 18 months)
- Participant Retention Rate(Through study completion, an average of 18 months)
- Intervention Adherence Rate(During Intervention Period (2 weeks))
- Grip/Pinch Strength(Baseline and post-intervention (within 1 week of completing 2-week sCIMT program))
- Change in Health-Related Quality of Life from Baseline to Post-Intervention (EQ-5D-5L)(Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program))
- Number of Protocol Deviations(Through study completion, an average of 18 months)
- Number of Adverse Events(From enrollment to the end of treatment (approximately 2-4 weeks total participation window))
- Clinician Time per Session(During Each Intervention Session (2-week sCIMT program))
- Change in Fugl-Meyer Assessment (FMA) from Baseline to Post-Intervention(Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program))
- Change in 9-Hole Peg Test from Baseline to Post-Intervention(Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program))
- Change in the Motor Activity Log (MAL) from Baseline to Post-Intervention(Baseline and post-intervention (within 1 week following completion of the intervention))
- Change in Box and Block Test (BBT) from Baseline to Post-Intervention(Baseline and post-intervention (within 1 week of completing 2-week sCIMT program))
- Sensory Testing(Baseline and post-intervention (within 1 week of completing 2-week sCIMT program))
- Change in Health-Related Quality of Life from Baseline to Post-Intervention (SF-36)(Baseline and post-intervention (within 1 week of completing 2-week sCIMT program))
- Semi-Structured Interviews(Post-Intervention (within 1 week of completing the 2-week sCIMT program))
研究者
Lauren Wengerd
Assistant Professor
Ohio State University