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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04315389
Acronym
SHARPCARE
Enrollment
52
Registered
2020-03-19
Start date
2020-12-02
Completion date
2022-09-07
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Joint Replacement Surgery, Spinal Cord Injuries, Stroke, Traumatic Brain Injury With Loss of Consciousness

Keywords

Assistive robots

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.

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.

Interventions

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.

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

Sponsors

Nanyang Technological University
CollaboratorOTHER
Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of TACSubject involvement 3 days, non consecutive, study duration 12 monthsTo 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 MRBASubject involvement 3 days, non consecutive, study duration 12 monthsTo 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

MeasureTime frameDescription
Impact on healthcare staff and patient usability, feasibility, productivity of devicesAssessed within 30 days after patient recruitmentFurther improvement and iterations of devices

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026