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

NCT ID: NCT04315389

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-02

Study Completion Date

2022-09-07

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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EXPERIMENTAL

OPEN LABEL USING HEALTHCARE ROBOTS IN PARALLEL (non comparison) EXPOSURE: 90 MINUTES 3 TIMES PER DAY FOR 3 DAYS, NON CONSECUTIVE

(1) Mobile Assistant Balance Robot

Intervention Type 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.

(2) Transfer Assistive Cobot

Intervention Type 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

Interventions

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(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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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MRBA TAC

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Chua, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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DSRB 2019/01015

Identifier Type: -

Identifier Source: org_study_id

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