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

Stroke Clinical Trial

— SHARPCARE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315389
• Other study ID #: DSRB 2019/01015
• Status: Completed
• Start date: December 2, 2020
• Est. completion date: September 7, 2022

Study information

• Verified date: April 2023
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• (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

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Impact on healthcare staff and patient usability, feasibility, productivity of devices	Further improvement and iterations of devices	Assessed within 30 days after patient recruitment