Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
研究概览
简要总结
Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT). This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with subacute stroke. It was hypothesized that participants receiving the combined treatment (SR and CIMT) would have a better functional regain.
详细描述
Background - Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT).
Objective - This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with sub-acute stroke.
Methods - Seventy-six patients were randomly assigned to the self-regulated constraint-induced movement therapy (SR-CIMT; n=25), constraint-induced movement therapy (CIMT; n=27) or conventional functional rehabilitation (control; n=24) groups, and completed the trial.
The SR-CIMT intervention was two-week therapist-guided training using the SR strategy to reflect on the relearning of functional tasks with CIMT. Outcome measurements were for upper limb function (Action Research Arm Test, ARAT, Fugl-Meyer Assessment, FMA), daily task performance (Lawton Instrumental Activities of Daily Living Scale, Lawton IADL) and self-perceived functional ability (Motor Activity Log, MAL) at pre and post intervention intervals, and at one month follow up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia,
- •had stroke onset of less than 3 months,
- •were aged above 60, and
- •had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint
排除标准
- •had excessive spasticity in the affected limb, as defined by a score of 2 or more on the Modified Ashworth Scale,
- •had excessive pain in the affected limb, as defined by a score 4 or more using a Visual Analog Scale,
- •had a score below 19 on the Mini-Mental Status Examination (MMSE), and
- •had diagnosed of depression according to Diagnostic and Statistical Manual-IV (DSM-IV) criteria
研究组 & 干预措施
Conventional occupational therapy
It involved therapist to demonstrate the adapted task performance followed by patient's practice under supervision.
干预措施: Conventional occupational therapy (Other)
Self-regulated constraint-induced movement therapy
Self-regulated constraint-induced movement therapy (SR-CIMT) - participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days) (CIMT) (the same CIMT protocol as in the CIMT group described under 'comparator/control treatment'); participants were taught using the self-regulation (SR) strategy to relearn the tasks; SR strategy involved participants self reflecting on their abilities and deficits in performing the tasks, identifying problems and solutions in achieving the most independence in the tasks, and then actually carrying out the tasks.
干预措施: Self-regulated constraint-induced movement therapy (Other)
Constraint-induced movement therapy
In the constraint-induced movement therapy group (CIMT), participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days); therapist provided demonstration on the adapted task performance with one arm (the side of participants' hemiplegic arm), and participants to practice the tasks with the unrestrained hemiplegic arm under supervision.
干预措施: Constraint-induced movement therapy (Other)
结局指标
主要结局
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
时间窗: Baseline and one month after the intervention completed (1 month and 2 weeks)
Performance assessment on 8 daily tasks
Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention
时间窗: Baseline and after the intervention (2 weeks)
Performance assessment on 8 daily tasks
Change from baseline in Action Research Arm Test after the intervention
时间窗: Baseline and after the intervention (2 weeks)
Performance assessment on arm function
Change from baseline in Action Research Arm Test at one month after the intervention completed
时间窗: Baseline and one month after the intervention completed (1 month and 2 weeks)
Performance assessment on arm function
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention
时间窗: Baseline and after the intervention (2 weeks)
Performance assessment on arm function
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed
时间窗: Baseline and one month after the intervention completed (1 month and 2 weeks)
Performance assessment on arm function
次要结局
- Change from baseline in Motor Activity Log-28 at one month after the intervention completed(Baseline and one month after the intervention completed (1 month and 2 weeks))
- Change from baseline in Motor Activity Log-28 after the intervention(Baseline and after the intervention (2 weeks))
研究者
Karen Liu
Associate Professor
University of Western Sydney