Effects of Robot-mediated Impairment-Oriented and Task-Specific Training on Upper Limb Outcomes Post Stroke (RMT-Stroke Outcomes)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Change of FMA-UE(Fugl Meyer Assessment for Upper Extremity) from baseline
研究概览
简要总结
This study aims to determine the clinical outcomes of stroke patients who are provided with adjunctive robot-mediated task specific therapy(RMTT) and robot-mediated impairment training (RMIT) as compared to those who are provided with adjunctive RMIT.
详细描述
Stroke is among the top 10 causes of hospitalisation in Singapore1. Approximately 630 stroke patients were transferred to our inpatient rehabilitation unit in 2021. Upper limb impairments are common after stroke2 and may result in loss of function, including self-care activities. Intensity of therapy is thus important for post-stroke recovery. A Cochrane overview of systematic reviews suggested that arm function can be improved by providing at least 20 hours of additional repetitive task training to patients3. However, providing sufficient therapy remains a challenge due to various reasons4, including manpower shortages. Robotic-mediated rehabilitation is an innovative exercise-based therapy using robotic devices that enables the implementation of highly repetitive, intensive, adaptive, and quantifiable physical training.
The RATULS trial5 showed that neither robot-assisted training using the MIT-Manus robotic gym nor an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice improved upper limb function after stroke, as compared to usual care, for patients with moderate-to-severe upper limb functional limitations. It was suggested that further research was needed to find ways to translate the improvements in upper limb impairments seen with robot-assisted therapy into upper limb function and their activities of daily living (ADLs).
In a systematic review and meta-analysis on the effects of robot-assisted therapy on the upper limb, it was found that although there were improvements in strength, this was not translated to improvements in activities of daily living6. Additional transition to task training (facilitated by therapists) had been added to robot-mediated impairment training (RMIT) in various studies7,8. In a study by Hung8, robot-assisted therapy combined with occupational therapist (OT)-facilitated task specific training was found to be superior to robot-assisted therapy combined with OT-facilitated impairment-oriented training. Task-specific training consists of repetitively practising the tasks that are most relevant to the patient and their personal context, whereas impairment-oriented therapy emphasises remediation of motor deficits with a focus on single joint movements at a time.
A study that investigated Reharob, a robotic device used to assist patients living with chronic stroke in performing 5 ADLs, showed that patients had significant improvements on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), Action Research Arm Test (ARAT) and Functional Independence Measure (FIM)9. This is the only study that has been found addressing robot-mediated task-specific training thus far (RMTT).
This study aims to determine the clinical outcomes of stroke patients who are provided with both RMTT and robot-mediated impairment training (RMIT) in addition to conventional therapy, as compared to those who are provided with only adjunctive RMIT. From a review of the prevalent literature, there has been no study on the comparison of RMTT + RMIT against RMIT alone. A search for RMTT only yielded the study on Reharob, but the robot only administered RMTT and not RMIT.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
To prevent subversion of the allocation sequence, study team members who enroll patients to the trial will be distinct and kept separate from the study team member that perform the randomization. We will establish the procedures to maintain separation between study team members that assess the outcomes, and those that perform group assignment. At the start of every assignment, patients will be reminded to not reveal their treatment assignment by referring to elements of the treatment that are unique to their treatment group.
Functional outcome scales are performed by blinded therapists who work in the unit.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke as evidenced by CT/MRI findings
- •First-ever stroke (ischaemic or haemorrhagic)
- •Upper limb weakness and an FMA-UE score of 16-53 (severe to moderate: 16-
- •moderate to mild: 35-53)12,13
- •Cognitively intact to follow instructions
- •Medically stable to participate
- •Consent given
- •Age 21 and above
排除标准
- •Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable
- •Involvement in another concurrent upper limb study
- •Wounds that do not allow donning of the device
- •Severe spasticity
- •Cognitive impairment (MMSE ≤20)
- •Inability to follow instructions
- •Severe osteoporosis
- •Infectious diseases that require the patient to be isolated in a single room eg airborne diseases
研究组 & 干预措施
Robot mediated Impairment-oriented training(RMIT)
Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen
干预措施: Robot mediated upper limb therapy (Device)
Robot mediated impairment-oriented and task-specific training (RMIT+RMTT)
Participant receives a total of 20 hours of robotic therapy. 10 hours will be in the form of RMIT and 10 hours in the form of RMTT
干预措施: Robot mediated upper limb therapy (Device)
结局指标
主要结局
Change of FMA-UE(Fugl Meyer Assessment for Upper Extremity) from baseline
时间窗: baseline, 1 month and 3 months post commencement of intervention
30 items assessing motor function and 3 items assessing reflex function (0-66, higher scores indicates better outcomes)
次要结局
- Change of patient satisfaction survey from baseline(baseline, 1 month and 3 months post baseline)
- Change of FAT( Frenchay Arm Test) from baseline(baseline, 1 month and 3 months post baseline)
- Change of FMA-W/H (Fugl Meyer Assessment- Wrist/Hand) from baseline(baseline, 1 month and 3 months post commencement of intervention)
- Change of MMT( manual muscle testing) from baseline(baseline, 1 month and 3 months post baseline)
- Change of FMA-UA( Fugl Meyer Assessment-Upper Arm) from baseline(baseline, 1 month and 3 months post commencement of intervention)
- Change of FIM (Functional Independence Measure) from baseline(baseline, 1 month, 3 months post baseline)
- Change of MAS (Modified Ashworth Scale) from baseline(baseline, 1 month and 3 months post baseline)
- Change of EQ5D from baseline(baseline, 1 month and 3 months post baseline)
- Change of HADS (Hospital Anxiety and Depression Scale) from baseline(baseline, 1 month and 3 months post baseline)
- Difference in the presence of adverse effects(baseline, 1 month and 3 months post baseline)