An interventional study of Robot mediated upper limb therapy in Stroke, sponsored by Changi General Hospital. Status unknown. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Changi General Hospital · Not applicable, Interventional, and Treatment
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:
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 4 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Changi General Hospital is the lead sponsor of 98 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen
Other: Robot mediated upper limb therapy
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
Other: Robot mediated upper limb therapy
The OR is classified as a Class A device with the Health Sciences Authority. The OR is capable of both delivering RMIT as well as RMTT. It can provide zero, partial, or full assistance to the patient to complete the movement or task. Its teach-and-follow mode allows a movement to be performed by the therapist, with the device then "replaying" the movement at either zero, partial, or full assistance, for the patient. Impairment oriented training will focus on the following movements: 1. Diagonal movement 2. Shoulder abduction 3. Shoulder adduction 4. Shoulder flexion 5. Shoulder extension 6. Elbow flexion 7. Elbow extension Task-specific training will focus on the following activities: 1. Picking up a cup/glass by the side and drink 2. Brushing hair 3. Cleaning unaffected upper limb (hand to arm) 4. Wiping table 5. Wiping wall 6. Sliding card on table to a designated location 7. Clipping a clothe peg
Change of FMA-UE (Fugl Meyer Assessment for Upper Extremity) from baseline
30 items assessing motor function and 3 items assessing reflex function (0-66, higher score indicates better outcome)
Time frame: baseline, 1 month and 3 months post commencement of intervention
Change of FMA-UA (Fugl Meyer Assessment-Upper Arm) from baseline
subset of FMA-UE(0-36, higher score indicates better outcome)
Time frame: baseline, 1 month and 3 months post commencement of intervention
Change of FMA-W/H(Fugl Meyer Assessment-Wrist/Hand) from baseline
subset of FMA-UE (0-30, higher score indicates better outcome)
Time frame: baseline, 1 month and 3 months post commencement of intervention
Change of FAT (Frenchay Arm Test) from baseline
Upper limb functional assessment (0-5, higher score indicates better outcome)
Time frame: baseline, 1 month and 3 months post baseline
Change of FIM (Functional Independence Measure) from baseline
Functional outcome measure, mainly used in inpatient setting (18-126, higher score indicate better outcome)
Time frame: baseline, 1 month, 3 months post baseline
Change of MMT (manual muscle testing) from baseline
using the Medical Research Council (0-5, higher indicate better outcome)
Time frame: baseline, 1 month and 3 months post baseline
Change MAS (Modified Ashworth Scale) from baseline
spasticity assessment scale (0-4, lower indicates better outcome)
Time frame: baseline, 1 month and 3 months post baseline
Change of EQ-5D from baseline
Quality of Life Questionaire ( 0-100, higher score indicates better outcome)
Time frame: baseline, 1 month and 3 months post baseline
Change of HADS (Hospital Anxiety and Depression Scale) from baseline
Measurement of mood (0-42, more than 8 points in each subcategory indicates considerable symptoms of anxiety or depression)
Time frame: baseline, 1 month and 3 months post baseline
Change of patient satisfaction survey from baseline
Patient satisfaction survey (8-40, higher score indicate good outcome)
Time frame: baseline, 1 month and 3 months post baseline
Difference in the presence of Adverse effects
fatigue, pain, injuries (present or absent. Absent denotes better outcome)
Time frame: baseline, 1 month and 3 months post baseline
No study locations are listed for this record.
Plan to share: No
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Changi General Hospital