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NCT Number: NCT04315389

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

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.

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Key information

Conditions

Stroke Acquired Brain Injury Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Joint Replacement Surgery Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Traumatic Brain Injury With Loss of Consciousness Vascular Diseases Wounds and Injuries

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(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.

Other names: MRBA

(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

Other names: TAC

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Nanyang Technological University

Registry information

Official study 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.

Acronym: SHARPCARE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2020
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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