Tan Tock Seng Hospital
Singapore
Location status: Recruiting
NCT Number: NCT06270459
There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.
In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors.
Interested in participating?
Request Info21 year–90 year
All sexes
Interventional
Not applicable
Singapore
Location status: Recruiting
Current models of care in public healthcare institutions (PHI) cannot provide daily or frequent access to RAT without increasing burden and expenditure in direct healthcare resources. Shifting from the existing hospital-based model of care towards a home-centered model based deploying portable RAT, would ensure that patients can continue to receive intensive therapy after discharge and during the chronic phase of stroke.
More recently, RAT deploying table-top, portable, less complex, upper limb end effectors enable clinic-to-home transitions may offer decentralized therapy, minimally supervised by therapists as a potential means to bridge various gaps in access to RAT such as scheduling, physical or social barriers, distances and hospital lockdowns related to viral pandemics.
This study aims to explore the utilization, feasibility and acceptability using a multi-cluster deployment and adoption of a decentralised robot-aided telerehabilitation (RATR) clinical programme supported by AI-enabled platform, with remote monitoring by clinic therapists
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The HMAN is certified as a CE class 2A upper limb rehabilitation robot suitable for hospital, clinic and home-based use in 2020 by Health Sciences Authority, Singapore. It has since been employed in post-stroke neurorehabilitation therapy and assessment of sensorimotor functions in stroke patients.
Time frame: Through study's data collection period, up to 2 years
Using cloud data from vendor, time (min/hours) of HMAN robot usage
Time frame: Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)
Change in Fugl Meyer Motor Assessment score in the affected arm
Time frame: Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)
Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function
Time frame: Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)
Measured by Digital Dynamometer (mean of 3 readings will be recorded)
Time frame: Week 6 (end of HMAN @ Home)
For evaluation of the HMAN robot's perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Time frame: Week 6 (end of HMAN @ Home)
To assess participants' subjective experience on usage of the HMAN robot using 4 separate subscales (Interest/Enjoyment, Perceived competence, Perceived choice, Pressure/Tension)
Contact information is provided by the study sponsor or research team.
Tan Tock Seng Hospital
Other
Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke (TRUST): a Study of Multi-cluster Adoption
Acronym: TRUST
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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