Clinical trial NCT04315389: SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Joint Replacement Surgery
Acquired Brain Injury
Spinal Cord Injuries
Traumatic Brain Injury With Loss of Consciousness
Keywords: Assistive robots
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2020-03-19
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients located in hospital wards or outpatient day rehabilitation centres

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.

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.

Eligibility 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.

Primary outcomes:
measure: Assessment of TAC
timeFrame: Subject involvement 3 days, non consecutive, study duration 12 months
measure: Assessment of MRBA
timeFrame: Subject involvement 3 days, non consecutive, study duration 12 months
Secondary outcomes:
measure: Impact on healthcare staff and patient usability, feasibility, productivity of devices
timeFrame: Assessed within 30 days after patient recruitment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Karen Chua, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: