StrokeNCT05729633
Robot Mediated Therapy-Feasibility Study and Preliminary Effects
A study testing Robot mediated upper limb therapy in people with Stroke, run by Changi General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot mediated upper limb therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (investigating adult stroke patients)
Who cannot join
- Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable
- Involvement in another concurrent upper limb study
- Wounds that do not allow donning of the device
- Severe spasticity
- Cognitive impairment (MMSE ≤20)
- Inability to follow instructions
- Severe osteoporosis
- Infectious diseases
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Stroke
- Being tested
- Robot mediated upper limb therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot mediated upper limb therapyOther
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:
- 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
| Study group | Role | What they receive |
|---|---|---|
| Robot mediated Impairment-oriented training(RMIT) | Experimental | Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen Receives: Other: Robot mediated upper limb therapy |
| Robot mediated impairment-orientyed and task-specific training (RMIT+RMTT) | Experimental | 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 Receives: Other: Robot mediated upper limb therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, 1 month and 3 months post commencement of intervention
Secondary outcomes (10)
Change of FMA-UA (Fugl Meyer Assessment-Upper Arm) from baseline
subset of FMA-UE(0-36, higher score indicates better outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline, 1 month and 3 months post baseline
Change MAS (Modified Ashworth Scale) from baseline
spasticity assessment scale (0-4, lower indicates better outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline, 1 month and 3 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tay San San, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729633
- Sponsor's protocol ID
- 202301-00007
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31328671Mehrholz 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.
PubMed 30175845Hung 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.
PubMed 30839256
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05729633
- Acronym / sponsor ID
- 202301-00007
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Robot mediated Impairment-oriented training(RMIT) | Experimental | Other: Robot mediated upper limb therapyParticipant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen |
| Robot mediated impairment-orientyed and task-specific training (RMIT+RMTT) | Experimental | Other: Robot mediated upper limb therapyParticipant 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 |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable
- Involvement in another concurrent upper limb study
- Wounds that do not allow donning of the device
- Severe spasticity
- Cognitive impairment (MMSE ≤20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot mediated upper limb therapyThe 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 | Other | Robot mediated Impairment-oriented training(RMIT), Robot mediated impairment-orientyed and task-specific training (RMIT+RMTT) |
Primary outcome
Change of FMA-UE (Fugl Meyer Assessment for Upper Extremity) from baseline
Time frame: baseline, 1 month and 3 months post commencement of intervention
30 items assessing motor function and 3 items assessing reflex function (0-66, higher score indicates better outcome)
10 secondary outcomes
Change of FMA-UA (Fugl Meyer Assessment-Upper Arm) from baseline
Time frame: baseline, 1 month and 3 months post commencement of intervention
Change of FMA-W/H(Fugl Meyer Assessment-Wrist/Hand) from baseline
Time frame: baseline, 1 month and 3 months post commencement of intervention
Change of FAT (Frenchay Arm Test) from baseline
Time frame: baseline, 1 month and 3 months post baseline
Change of FIM (Functional Independence Measure) from baseline
Time frame: baseline, 1 month, 3 months post baseline
Change of MMT (manual muscle testing) from baseline
Time frame: baseline, 1 month and 3 months post baseline
Change MAS (Modified Ashworth Scale) from baseline
Time frame: baseline, 1 month and 3 months post baseline
Change of EQ-5D from baseline
Time frame: baseline, 1 month and 3 months post baseline
Change of HADS (Hospital Anxiety and Depression Scale) from baseline
Time frame: baseline, 1 month and 3 months post baseline
Change of patient satisfaction survey from baseline
Time frame: baseline, 1 month and 3 months post baseline
Difference in the presence of Adverse effects
Time frame: baseline, 1 month and 3 months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 31328671Conroy 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.
- Background: PubMed 30175845Mehrholz 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.
- Background: PubMed 30839256Hung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Robot mediated upper limb therapy in people with Stroke, run by Changi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact San San Tay, MBBS (+6569366455, tay.san.san@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of FMA-UE (Fugl Meyer Assessment for Upper Extremity) from baseline (time frame: baseline, 1 month and 3 months post commencement of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729633, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.