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Robot Mediated Therapy-Upper Limb Outcomes in Stroke

Primary Purpose

Stroke, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robot mediated upper limb therapy
Sponsored by
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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: 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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Robot mediated Impairment-oriented training(RMIT)

    Robot mediated impairment-oriented and task-specific training (RMIT+RMTT)

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

    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 scores indicates better outcomes)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Changi General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05805644
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changi General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled study
    Masking
    Care ProviderOutcomes 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.
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Robot mediated Impairment-oriented training(RMIT)
    Arm Type
    Experimental
    Arm Description
    Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen
    Arm Title
    Robot mediated impairment-oriented and task-specific training (RMIT+RMTT)
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Device
    Intervention Name(s)
    Robot mediated upper limb therapy
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change of FMA-UE(Fugl Meyer Assessment for Upper Extremity) from baseline
    Description
    30 items assessing motor function and 3 items assessing reflex function (0-66, higher scores indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post commencement of intervention
    Secondary Outcome Measure Information:
    Title
    Change of FMA-UA( Fugl Meyer Assessment-Upper Arm) from baseline
    Description
    subset of FMA-UE( 0-36, higher score indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post commencement of intervention
    Title
    Change of FMA-W/H (Fugl Meyer Assessment- Wrist/Hand) from baseline
    Description
    subset of FMA-UE (0-30, higher scores indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post commencement of intervention
    Title
    Change of FAT( Frenchay Arm Test) from baseline
    Description
    Upper limb functional assessment (0-5, higher score indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post baseline
    Title
    Change of FIM (Functional Independence Measure) from baseline
    Description
    Functional outcome measure, mainly used in inpatient setting (18-126, higher score indicates better outcomes)
    Time Frame
    baseline, 1 month, 3 months post baseline
    Title
    Change of MMT( manual muscle testing) from baseline
    Description
    Using the Medical Research Council scale (0-5, higher indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post baseline
    Title
    Change of MAS (Modified Ashworth Scale) from baseline
    Description
    spasticity assessment scale (0-4, lower indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post baseline
    Title
    Change of EQ5D from baseline
    Description
    Quality of Life Questionaire (0-100, higher score indicates better outcomes)
    Time Frame
    baseline, 1 month and 3 months post baseline
    Title
    Change of HADS (Hospital Anxiety and Depression Scale) from baseline
    Description
    Masurement 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
    Title
    Change of patient satisfaction survey from baseline
    Description
    Patient satisfaction survey (8-40), higher score denotes good outcome)
    Time Frame
    baseline, 1 month and 3 months post baseline
    Title
    Difference in the presence of adverse effects
    Description
    fatigue, pain, injuries (present or absent. Absent denotes better outcome)
    Time Frame
    baseline, 1 month and 3 months post baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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 -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    San San Tay, MBBS
    Phone
    69366455
    Email
    tay.san.san@singhealth.com.sg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Edmund Neo, MBBS
    Phone
    69366462
    Email
    neo.jin.rui.edmund@singhealth.com.sg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31328671
    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.
    Results Reference
    result
    PubMed Identifier
    30175845
    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.
    Results Reference
    result
    PubMed Identifier
    30839256
    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.
    Results Reference
    result

    Learn more about this trial

    Robot Mediated Therapy-Upper Limb Outcomes in Stroke

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