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

Study Overview
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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.

Official Title
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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.

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

Intervention / Treatment
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* Device: (1) Mobile Assistant Balance Robot
* Device: (2) Transfer Assistive Cobot


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EXPERIMENTAL<br>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<br>* 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.<br>* Other names: MRBA;Device: (2) Transfer Assistive Cobot<br>* 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<br>* Other names: TAC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on healthcare staff and patient usability, feasibility, productivity of devices | Further improvement and iterations of devices | Assessed within 30 days after patient recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assistive robots