Clinical trial NCT05805644: Robot Mediated Therapy-Upper Limb Outcomes in Stroke
Official title: Effects of Robot-mediated Impairment-Oriented and Task-Specific Training on Upper Limb Outcomes Post Stroke (RMT-Stroke Outcomes)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The target patients would be those with acute stroke undergoing rehabilitation in an acute inpatient rehabilitation unit. Robotic therapy can continue when they are discharged, in the outpatient setting.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of stroke as evidenced by CT/MRI findings
2. First-ever stroke (ischaemic or haemorrhagic)
3. Upper limb weakness and an FMA-UE score of 16-53 (severe to moderate: 16-34. moderate to mild: 35-53)12,13
4. Cognitively intact to follow instructions
5. Medically stable to participate
6. Consent given
7. Age 21 and above

Exclusion Criteria:

1. Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable 2. Involvement in another concurrent upper limb study 3. Wounds that do not allow donning of the device 4. Severe spasticity 5. Cognitive impairment (MMSE ≤20) 6. Inability to follow instructions 7. Severe osteoporosis 8. Infectious diseases that require the patient to be isolated in a single room eg airborne diseases

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Primary outcomes:
measure: Change of FMA-UE(Fugl Meyer Assessment for Upper Extremity) from baseline
timeFrame: baseline, 1 month and 3 months post commencement of intervention
Secondary outcomes:
measure: Change of FMA-UA( Fugl Meyer Assessment-Upper Arm) from baseline
timeFrame: baseline, 1 month and 3 months post commencement of intervention
measure: Change of FMA-W/H (Fugl Meyer Assessment- Wrist/Hand) from baseline
timeFrame: baseline, 1 month and 3 months post commencement of intervention
measure: Change of FAT( Frenchay Arm Test) from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Change of FIM (Functional Independence Measure) from baseline
timeFrame: baseline, 1 month, 3 months post baseline
measure: Change of MMT( manual muscle testing) from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Change of MAS (Modified Ashworth Scale) from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Change of EQ5D from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Change of HADS (Hospital Anxiety and Depression Scale) from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Change of patient satisfaction survey from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Difference in the presence of adverse effects
timeFrame: baseline, 1 month and 3 months post baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Conroy SS, Wittenberg GF, Krebs HI, Zhan M, Bever CT, Whitall J. Robot-Assisted Arm Training in Chronic Stroke: Addition of Transition-to-Task Practice. Neurorehabil Neural Repair. 2019 Sep;33(9):751-761. doi: 10.1177/1545968319862558. Epub 2019 Jul 22.
citation: Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.
citation: Hung CS, Hsieh YW, Wu CY, Lin KC, Lin JC, Yeh LM, Yin HP. Comparative Assessment of Two Robot-Assisted Therapies for the Upper Extremity in People With Chronic Stroke. Am J Occup Ther. 2019 Jan/Feb;73(1):7301205010p1-7301205010p9. doi: 10.5014/ajot.2019.022368.