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

T

Tan Tock Seng Hospital

Status

Completed

Conditions

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

Treatments

Device: (2) Transfer Assistive Cobot
Device: (1) Mobile Assistant Balance Robot

Study type

Observational

Funder types

Other

Identifiers

NCT04315389
DSRB 2019/01015

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

52 participants in 1 patient group

EXPERIMENTAL
Description:
OPEN LABEL USING HEALTHCARE ROBOTS IN PARALLEL (non comparison) EXPOSURE: 90 MINUTES 3 TIMES PER DAY FOR 3 DAYS, NON CONSECUTIVE
Treatment:
Device: (1) Mobile Assistant Balance Robot
Device: (2) Transfer Assistive Cobot

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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