StrokeSHARPCARENCT04315389
SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study
An observational study of Stroke and Joint Replacement Surgery, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Robots are commonly used in many settings to help with transportation needs, reduce human injuries, and assisting clinicians during surgeries. These applications could provide direct benefits to patients in the clinical rehabilitation field. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Stroke, Joint Replacement Surgery, Acquired Brain Injury
- What is being tested?
- (1) Mobile Assistant Balance Robot and (2) Transfer Assistive Cobot
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Dec 2020to 7 Sep 2022
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients located in hospital wards or outpatient day rehabilitation centres
Who may be able to join
- Aged 21-85 years
- Primary reason for admission is in /outpatient rehabilitation.
- Admission (within 72 hours) Functional Independence Measure (FIM)(transfer/walk) score of 1-5 or Modified Barthel Index Score (transfer/walk) of 0, 5 or 10.
- Activity tolerance for ambulant patients of >30 minutes.
- Patient able to sign own consent and understand simple instructions.
Who cannot join
- Pregnancy or lactation.
- Medical instability, uncontrolled sepsis, orthostatic hypotension, contraindications to verticalization. (unstable spinal fractures, severe pain) weight-bearing on either limb), abdominal aneurysms
- Patients with behavioural problems (agitation, untreated depression, psychiatric problems)
- Skin conditions which could be worsen by the abdominal, trunk, knee and calf cuffs of straps of the CARE robots.
- Patients who are unable to sign own consent or understand simple instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study of Care Assistant and Rehabilitation Enabling (CARE) Robots: A Multi-centre Study to Establish Safety and Feasibility Through the Rehabilitation Care Continuum.
Robots are commonly used in many settings to help with transportation needs, reduce human injuries, and assisting clinicians during surgeries. These applications could provide direct benefits to patients in the clinical rehabilitation field.
In this study, the feasibility of 2 CARE robot prototypes in facilitating dependent transfers and assisting patient mobility in their daily living activities will be studied.
Read the detailed description
An exploratory proof of concept study involving the development and usability of 2 CARE robot prototypes will be validated in a hospital environment, in a broad range of patients.
The findings from this study will then be used to further refine and develop the robot prototypes for future deployment in other hospitals, nursing homes and homes.
- Conditions
- Stroke, Joint Replacement Surgery, Acquired Brain Injury, Spinal Cord Injuries, Traumatic Brain Injury With Loss of Consciousness
- Being tested
- (1) Mobile Assistant Balance Robot, (2) Transfer Assistive Cobot
- Keywords
- Assistive robots
- Medical subject headings
- Stroke, Brain Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(1) Mobile Assistant Balance RobotDevice
Also called MRBA
MRBA: Robotic wheelchair with a planar compliant robotic arm to provide balance assistance to the user at the pelvis and hip, during sit to stand, standing and walking tasks in indoor and controlled outdoor level environments.
(2) Transfer Assistive CobotDevice
Also called TAC
TAC: Intelligent powered wheelchair equipped with a robotic arm that is capable of lifting payload up to 110kg, and perform a totally dependent transfer in a semi- autonomous fashion
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | OPEN LABEL USING HEALTHCARE ROBOTS IN PARALLEL (non comparison) EXPOSURE: 90 MINUTES 3 TIMES PER DAY FOR 3 DAYS, NON CONSECUTIVE Receives: Device: (1) Mobile Assistant Balance Robot; Device: (2) Transfer Assistive Cobot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of TAC
To evaluate the ability of TAC to navigate autonomously when called and performing a totally dependent transfer with its robotic arm usually requiring 2 -3 persons to 1-1.5 persons.
Measured: Subject involvement 3 days, non consecutive, study duration 12 months
Assessment of MRBA
To evaluate the ability of MRBA to provide co-operative assistance as needed for patients who are able to ambulate with minimal aid during ambulation and standing tasks e.g. dressing or voiding.
Measured: Subject involvement 3 days, non consecutive, study duration 12 months
Secondary outcomes (1)
Impact on healthcare staff and patient usability, feasibility, productivity of devices
Further improvement and iterations of devices
Measured: Assessed within 30 days after patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start2 Dec 2020
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Karen Chua, MBBS, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315389
- Sponsor's protocol ID
- DSRB 2019/01015
- Acronym
- SHARPCARE
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NA no individualised data will be shared except within TTSH research team
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study of Care Assistant and Rehabilitation Enabling (CARE) Robots: A Multi-centre Study to Establish Safety and Feasibility Through the Rehabilitation Care Continuum.
- ClinicalTrials.gov ID
- NCT04315389
- Acronym / sponsor ID
- SHARPCARE / DSRB 2019/01015
- Conditions
- Stroke, Joint Replacement Surgery, Acquired Brain Injury, Spinal Cord Injuries, Traumatic Brain Injury With Loss of Consciousness
- Keywords
- Assistive robots
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 19 Mar 2020 (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.
Robots are commonly used in many settings to help with transportation needs, reduce human injuries, and assisting clinicians during surgeries. These applications could provide direct benefits to patients in the clinical rehabilitation field.
In this study, the feasibility of 2 CARE robot prototypes in facilitating dependent transfers and assisting patient mobility in their daily living activities will be studied.
Detailed description
An exploratory proof of concept study involving the development and usability of 2 CARE robot prototypes will be validated in a hospital environment, in a broad range of patients.
The findings from this study will then be used to further refine and develop the robot prototypes for future deployment in other hospitals, nursing homes and homes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | – | Device: (1) Mobile Assistant Balance Robot, Device: (2) Transfer Assistive CobotOPEN LABEL USING HEALTHCARE ROBOTS IN PARALLEL (non comparison) EXPOSURE: 90 MINUTES 3 TIMES PER DAY FOR 3 DAYS, NON CONSECUTIVE |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients located in hospital wards or outpatient day rehabilitation centres
Key inclusion criteria (5 listed)
- Aged 21-85 years
- Primary reason for admission is in /outpatient rehabilitation.
- Admission (within 72 hours) Functional Independence Measure (FIM)(transfer/walk) score of 1-5 or Modified Barthel Index Score (transfer/walk) of 0, 5 or 10.
- Activity tolerance for ambulant patients of >30 minutes.
- Patient able to sign own consent and understand simple instructions.
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Medical instability, uncontrolled sepsis, orthostatic hypotension, contraindications to verticalization. (unstable spinal fractures, severe pain) weight-bearing on either limb), abdominal aneurysms
- Patients with behavioural problems (agitation, untreated depression, psychiatric problems)
- Skin conditions which could be worsen by the abdominal, trunk, knee and calf cuffs of straps of the CARE robots.
- Patients who are unable to sign own consent or understand simple instructions.
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 |
|---|---|---|
| (1) Mobile Assistant Balance RobotAlso: MRBAMRBA: Robotic wheelchair with a planar compliant robotic arm to provide balance assistance to the user at the pelvis and hip, during sit to stand, standing and walking tasks in indoor and controlled outdoor level environments. | Device | EXPERIMENTAL |
| (2) Transfer Assistive CobotAlso: TACTAC: Intelligent powered wheelchair equipped with a robotic arm that is capable of lifting payload up to 110kg, and perform a totally dependent transfer in a semi- autonomous fashion | Device | EXPERIMENTAL |
Primary outcome
Assessment of TAC
Time frame: Subject involvement 3 days, non consecutive, study duration 12 months
To evaluate the ability of TAC to navigate autonomously when called and performing a totally dependent transfer with its robotic arm usually requiring 2 -3 persons to 1-1.5 persons.
Assessment of MRBA
Time frame: Subject involvement 3 days, non consecutive, study duration 12 months
To evaluate the ability of MRBA to provide co-operative assistance as needed for patients who are able to ambulate with minimal aid during ambulation and standing tasks e.g. dressing or voiding.
1 secondary outcome
Impact on healthcare staff and patient usability, feasibility, productivity of devices
Time frame: Assessed within 30 days after patient recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No. NA no individualised data will be shared except within TTSH research team
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Karen Chua, MBBS, MD principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Joint Replacement Surgery, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of TAC (time frame: Subject involvement 3 days, non consecutive, study duration 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2023.