Effect of the Dose of a Task Specific Training Program and Armeo Spring on Upper Limb Motor Recovery in Chronic Stroke: Randomized Clinical Trial
概览
- 阶段
- 不适用
- 干预措施
- Intensive training with robotic exoskeleton for upper limbs
- 疾病 / 适应症
- Stroke
- 发起方
- Universidad de Zaragoza
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assesment (FMA)
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients.
20 stroke patients were randomly divided into two groups: the intensive group and the control group.
The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day.
The intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day.
详细描述
Abtract Introduction: Intensive rehabilitation and task-specific training (TST) are essential for recovery after stroke. Devices such as Armeo Spring allow for increased repetitions while maintaining specificity. The objective was to compare the effect of a high-repetition dose versus a low-repetition dose using a combined program of Armeo Spring and TST on upper limb recovery in patients with chronic stroke. Methods: Randomized, single-blind clinical trial with 20 participants (\>6 months post-stroke). Participants were assigned to two groups: High Repetition (HR; 40 hours total, 2 hours/session, 5 days/week) and Low Repetition (LR; 12 hours total, 1 hour/session, 3 days/week) for 4 weeks. The primary outcome measure was the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Assessments were performed at baseline (T0), post-intervention (T1), and one month (T2). Results: Both groups showed significant improvements in the FMA-UE (p \< 0.01). The HR group improved by 10.80 points (SD = 5.92) and the BR group by 5.90 points (SD = 3.54) at T1 and remained stable at T2. The intergroup comparison significantly favored the HR group at T1 and T2 (p \< 0.02), with superior benefits also in dexterity, independence, and perception of performance. The effect size was greater in the HR group (d = 0.712) than in the LR group (d = 0.435) between T0 and T1, but at T2, the effect size was small in both groups. Conclusions: Armeo Spring therapy and high-repetition TST proved to be more effective in improving upper limb functionality in patients with chronic stroke at the end of the intervention and at the one-month follow-up.
研究者
Enrique Villa Berges
PhD Principal investigator
Universidad de Zaragoza
入排标准
入选标准
- •People diagnosed with stroke (ischaemic or haemorrhagic).
- •Patients in a subacute or chronic state.
- •Patients must be over 18 years of age and under 80 years of age.
- •Patients with impaired functionality of the upper limb.
排除标准
- •Persons diagnosed with other pathologies, other than those indicated in the inclusion criteria.
- •Montreal Cognitive Assessment (MoCA), the minimum score to be achieved will be 22 points.
- •Severe difficulties in understanding language (aphasia).
- •Behavioural or behavioural disturbance.
- •Treatment with botulinum toxin 3 months prior to the intervention.
研究组 & 干预措施
Control group
The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day.
干预措施: Intensive training with robotic exoskeleton for upper limbs
Control group
The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day.
干预措施: Task specific training
Intensive group
The intensive group will be trained with robotic exoskeleton for upper limbs and task specific training, 5 sessions per week for 4 weeks, for 2 hours per day.
干预措施: Intensive training with robotic exoskeleton for upper limbs
Intensive group
The intensive group will be trained with robotic exoskeleton for upper limbs and task specific training, 5 sessions per week for 4 weeks, for 2 hours per day.
干预措施: Task specific training
结局指标
主要结局
Fugl Meyer Assesment (FMA)
时间窗: Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement
Primary Outcome Measure. It is a scale where the area of assessment includes ADLs, functional mobility and pain. ICF Domain, Body Function.Minimal Detectable Change (MDC) FMA = 5.2 points for the Upper Extremity portion of the assessment
次要结局
- Box and Blocks Test (BBT)(Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.)
- Dynamometer(Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.)
- Funcitonal Independence Measure (FIM)(Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.)
- Canadian Occupational Performance Measure (COPM)(Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.)
- Motor Activity Log (MAL)(Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.)
- Stroke Impact Scale (SIS). To assess physical function following stroke. ICF Domain Activity. Minimal Detectable Change (MDC)MDC >= 8(Assessments occur at baseline, 4 weeks of intervention, and at 1 month after intervention commencement.)