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

NCT04315389 | Completed

• 1 other identifier: DSRB 2019/01015
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Assistive robots

Outcome Measures

Primary Outcomes (2)

• Assessment of TAC

  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

  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 Outcomes (1)

• Impact on healthcare staff and patient usability, feasibility, productivity of devices

  Assessed within 30 days after patient recruitment

Study Arms (1)

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; Device: (2) Transfer Assistive Cobot

Interventions

(1) Mobile Assistant Balance Robot DEVICE

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.

Also known as: MRBA

EXPERIMENTAL

(2) Transfer Assistive Cobot DEVICE

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

Also known as: TAC

EXPERIMENTAL

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients located in hospital wards or outpatient day rehabilitation centres

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Stroke; Brain Injuries; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases

Study Officials

• Karen Chua, MBBS, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: December 2, 2020
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)