Robot Mediated Therapy-Upper Limb Outcomes in Stroke

Sponsor

Changi General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05805644

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Device: Robot mediated upper limb therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled studyRandomized controlled study

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Effects of Robot-mediated Impairment-Oriented and Task-Specific Training on Upper Limb Outcomes Post Stroke (RMT-Stroke Outcomes)

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot mediated Impairment-oriented training(RMIT) Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen	Device: Robot mediated upper limb therapy The OR is classified as a Class A device with the Health Sciences Authority. The OR is capable of 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: Diagonal movement Shoulder abduction Shoulder adduction Shoulder flexion Shoulder extension Elbow flexion Elbow extension Task-specific training will focus on the following activities: Picking up a cup/glass by the side and drink Brushing hair Cleaning unaffected upper limb (hand to arm) Wiping table Wiping wall Sliding card on table to a designated location Clipping a clothe peg
Experimental: 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	Device: Robot mediated upper limb therapy The OR is classified as a Class A device with the Health Sciences Authority. The OR is capable of 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: Diagonal movement Shoulder abduction Shoulder adduction Shoulder flexion Shoulder extension Elbow flexion Elbow extension Task-specific training will focus on the following activities: Picking up a cup/glass by the side and drink Brushing hair Cleaning unaffected upper limb (hand to arm) Wiping table Wiping wall Sliding card on table to a designated location Clipping a clothe peg

Arm

Intervention/Treatment

Experimental: Robot mediated Impairment-oriented training(RMIT)

Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen

Device: Robot mediated upper limb therapy

The OR is classified as a Class A device with the Health Sciences Authority. The OR is capable of 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: Diagonal movement Shoulder abduction Shoulder adduction Shoulder flexion Shoulder extension Elbow flexion Elbow extension Task-specific training will focus on the following activities: Picking up a cup/glass by the side and drink Brushing hair Cleaning unaffected upper limb (hand to arm) Wiping table Wiping wall Sliding card on table to a designated location Clipping a clothe peg

Experimental: 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

Device: Robot mediated upper limb therapy

Outcome Measures

Primary Outcome Measures

Change of FMA-UE(Fugl Meyer Assessment for Upper Extremity) from baseline [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)

Secondary Outcome Measures

Change of FMA-UA( Fugl Meyer Assessment-Upper Arm) from baseline [baseline, 1 month and 3 months post commencement of intervention]
subset of FMA-UE( 0-36, higher score indicates better outcomes)
Change of FMA-W/H (Fugl Meyer Assessment- Wrist/Hand) from baseline [baseline, 1 month and 3 months post commencement of intervention]
subset of FMA-UE (0-30, higher scores indicates better outcomes)
Change of FAT( Frenchay Arm Test) from baseline [baseline, 1 month and 3 months post baseline]
Upper limb functional assessment (0-5, higher score indicates better outcomes)
Change of FIM (Functional Independence Measure) from baseline [baseline, 1 month, 3 months post baseline]
Functional outcome measure, mainly used in inpatient setting (18-126, higher score indicates better outcomes)
Change of MMT( manual muscle testing) from baseline [baseline, 1 month and 3 months post baseline]
Using the Medical Research Council scale (0-5, higher indicates better outcomes)
Change of MAS (Modified Ashworth Scale) from baseline [baseline, 1 month and 3 months post baseline]
spasticity assessment scale (0-4, lower indicates better outcomes)
Change of EQ5D from baseline [baseline, 1 month and 3 months post baseline]
Quality of Life Questionaire (0-100, higher score indicates better outcomes)
Change of HADS (Hospital Anxiety and Depression Scale) from baseline [baseline, 1 month and 3 months post baseline]
Masurement of mood (0-42, more than 8 points in each subcategory indicates considerable symptoms of anxiety or depression)
Change of patient satisfaction survey from baseline [baseline, 1 month and 3 months post baseline]
Patient satisfaction survey (8-40), higher score denotes good outcome)
Difference in the presence of adverse effects [baseline, 1 month and 3 months post baseline]
fatigue, pain, injuries (present or absent. Absent denotes better outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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: 16-34. moderate to mild: 35-53)12,13
Cognitively intact to follow instructions
Medically stable to participate
Consent given
Age 21 and above

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Changi General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changi General Hospital

ClinicalTrials.gov Identifier:

NCT05805644

Other Study ID Numbers:

ChangiGH1

First Posted:

Apr 10, 2023

Last Update Posted:

Apr 10, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Apr 10, 2023