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

• ClinicalTrials.gov Identifier: NCT04315389
• Recruitment Status: Completed
• First Posted: March 19, 2020
• Last Update Posted: April 26, 2023
• Sponsor: Tan Tock Seng Hospital
• Collaborator: Nanyang Technological University
• Information provided by (Responsible Party): Tan Tock Seng Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Stroke; Joint Replacement Surgery; Acquired Brain Injury; Spinal Cord Injuries; Traumatic Brain Injury With Loss of Consciousness	Device: (1) Mobile Assistant Balance Robot; Device: (2) Transfer Assistive Cobot

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 Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 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.
• Actual Study Start Date: December 2, 2020
• Actual Primary Completion Date: September 7, 2022
• Actual Study Completion Date: September 7, 2022

Groups and Cohorts

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 Name: 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 Name: TAC

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients located in hospital wards or outpatient day rehabilitation centres

Criteria

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.

Contacts and Locations

Locations

Singapore

Tan Tock Seng Hospital

Singapore, Singapore, 308433

Sponsors and Collaborators

Tan Tock Seng Hospital

Nanyang Technological University

Investigators

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

More Information

• Responsible Party: Tan Tock Seng Hospital
• ClinicalTrials.gov Identifier: NCT04315389
• Other Study ID Numbers: DSRB 2019/01015
• First Posted: March 19, 2020
• Last Update Posted: April 26, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: NA no individualised data will be shared except within TTSH research team

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tan Tock Seng Hospital:

Assistive robots

Additional relevant MeSH terms:

Brain Injuries; Spinal Cord Injuries; Brain Injuries, Traumatic; Unconsciousness; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations