ClinicalTrials.Veeva

Menu

Robot Mediated Therapy-Upper Limb Outcomes in Stroke

C

Changi General Hospital

Status

Not yet enrolling

Conditions

Stroke, Acute

Treatments

Device: Robot mediated upper limb therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05805644
ChangiGH1

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 2 patient groups

Robot mediated Impairment-oriented training(RMIT)
Experimental group
Description:
Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen
Treatment:
Device: Robot mediated upper limb therapy
Robot mediated impairment-oriented and task-specific training (RMIT+RMTT)
Experimental group
Description:
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
Treatment:
Device: Robot mediated upper limb therapy

Trial contacts and locations

0

Loading...

Central trial contact

Edmund Neo, MBBS; San San Tay, MBBS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems