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SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study (SHARPCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04315389
Recruitment Status : Completed
First Posted : March 19, 2020
Last Update Posted : April 26, 2023
Nanyang Technological University
Information provided by (Responsible Party):
Tan Tock Seng Hospital

Brief 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.

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.

Condition or disease Intervention/treatment
Stroke Joint Replacement Surgery Acquired Brain Injury Spinal Cord Injuries Traumatic Brain Injury With Loss of Consciousness Device: (1) Mobile Assistant Balance Robot Device: (2) Transfer Assistive Cobot

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
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.
Actual Study Start Date : December 2, 2020
Actual Primary Completion Date : September 7, 2022
Actual Study Completion Date : September 7, 2022

Group/Cohort Intervention/treatment
Device: (1) Mobile Assistant Balance Robot
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.
Other Name: MRBA

Device: (2) Transfer Assistive Cobot
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
Other Name: TAC

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Impact on healthcare staff and patient usability, feasibility, productivity of devices [ Time Frame: Assessed within 30 days after patient recruitment ]
    Further improvement and iterations of devices

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients located in hospital wards or outpatient day rehabilitation centres

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315389

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Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
Nanyang Technological University
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Principal Investigator: Karen Chua, MBBS, MD Tan Tock Seng Hospital
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Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT04315389    
Other Study ID Numbers: DSRB 2019/01015
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NA no individualised data will be shared except within TTSH research team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tan Tock Seng Hospital:
Assistive robots
Additional relevant MeSH terms:
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Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations