Clinical trial NCT05729633: Robot Mediated Therapy-Feasibility Study and Preliminary Effects
Official title: Robot-Mediated Impairment-Oriented and Task-Specific Training (RMIT and RMTT) on Upper Limb Post Stroke: Feasibility and Preliminary Effects on Physical Function and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 4
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: The goal of this clinical trial is to investigate the feasibility of the application of robot mediated impairment-training (RMIT) and robot mediated task-specific training (RMTT) in acute stroke patients with upper limb impairments.

The main question\[s\] it aims to answer are:

* Is it feasible and safe to conduct RMIT and RMTT in acute stroke patients with upper limb impairments?
* What are the preliminary effects on the physical function and quality of life in these patients?

Participants will undergo 20 hours of robot mediated upper limb therapy.

Researchers will compare RMIT with RMIT+RMTT to see if there are any differences in the effects on physical function and quality of life.

Detailed description: 1. BACKGROUND AND RATIONALE Stroke is among the top 10 causes of hospitalisation in Singapore. Approximately 630 stroke patients were transferred to our inpatient rehabilitation unit in 2021. Upper limb impairments are common after stroke 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 patients. However, providing sufficient therapy remains a challenge due to various reasons, 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 trial 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 living. Additional transition to task training (facilitated by therapists) had been added to robot-mediated impairment training (RMIT) in various studies. 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). This is the only study that has been found addressing robot-mediated task-specific training thus far (RMTT).

   This study aims to determine the feasibility of the application of both RMIT and RMTT utilizing the robotic device- Optimo Regen. 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 preliminary effects of the intervention on physical function and quality of life will be studied.

   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 clinic. According to a study on the cost of hospital care, the bulk of the hospitalisation cost went to ward charges (38.2%) with much less coming from therapy (7.3%). It thus makes sense to increase the intensity of rehabilitation so that patients may recover faster and be discharged earlier. Making therapy more available in the outpatient setting where wait times are currently long would also be advantageous.
2. HYPOTHESIS AND OBJECTIVES Hypothesis: Robot-mediated impairment-oriented and task-sepcific training improves upper limb function and is safe and feasible Objectives: To assess the feasibility of conducting robot mediated impairment-oriented training and task-specific training and to study the benefits on physical function and quality of life.

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 (investigating adult stroke patients)

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

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 MAS (Modified Ashworth Scale) from baseline
timeFrame: baseline, 1 month and 3 months post baseline
measure: Change of EQ-5D 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.