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

April 25, 2023 updated by: Tan Tock Seng Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients located in hospital wards or outpatient day rehabilitation centres

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EXPERIMENTAL
OPEN LABEL USING HEALTHCARE ROBOTS IN PARALLEL (non comparison) EXPOSURE: 90 MINUTES 3 TIMES PER DAY FOR 3 DAYS, NON CONSECUTIVE
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 Names:
  • 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 Names:
  • TAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Subject involvement 3 days, non consecutive, study duration 12 months
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.
Subject involvement 3 days, non consecutive, study duration 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed within 30 days after patient recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

Nanyang Technological University

Investigators

  • Principal Investigator: Karen Chua, MBBS, MD, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

September 7, 2022

Study Completion (Actual)

September 7, 2022

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB 2019/01015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

NA no individualised data will be shared except within TTSH research team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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