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

Completed

• Conditions: Acquired Brain Injury; Spinal Cord Injuries; Traumatic Brain Injury With Loss of Consciousness; Joint Replacement Surgery; Stroke
• Interventions: Device: (1) Mobile Assistant Balance Robot; Device: (2) Transfer Assistive Cobot

• Registration Number: NCT04315389
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-12-02
• Primary Completion: 2022-09-07
• Study Completion: 2022-09-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of TAC	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	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

Name	Time	Method
Impact on healthcare staff and patient usability, feasibility, productivity of devices	Assessed within 30 days after patient recruitment	Further improvement and iterations of devices

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore