Tan Tock Seng Hospital
Singapore
Location status: Recruiting
NCT Number: NCT06406569
Due to limited resources such as the low therapist to patient ratio or high costs associated to rehabilitation therapy, providing higher therapy dose to patients after discharge is highly challenging. This often results in non-use of the impaired limb as a result of the decreased therapy dose, causing partial loss of the functional improvements previously gained during early rehabilitation.
In this study, the investigators plan to pilot the HomeRehab Gym concept via the deployment of three rehabilitation devices at patients' homes: MyoPanda, H-Man and ReHandyBot.
Interested in participating?
Request Info21 year–80 year
All sexes
Interventional
Not applicable
Singapore
Location status: Recruiting
Previous research has proven that technology-aided upper limb rehabilitation is non-inferior in terms of feasibility and efficacy when compared to conventional therapy in stroke patients. These rehabilitation devices can be set up as a 'rehabilitation gym' (RehabGym), where patients can interact with several devices that target different body and rehabilitation domains and, thus allows for a holistic and complementary therapy.
Despite recent studies having shown that training with a RehabGym under reduced supervision in a hospital is not only feasible but also equally beneficial in terms of clinical outcomes, however, a RehabGym has never been set up at a patient's home to the best of our knowledge.
This study aims to investigate the feasibility and safety of a RehabGym at home concept using three different upper-limb technologies (H-Man, ReHandyBot, MyoPanda) that are established, clinically tested and allow for on-demand therapy. Objective measures of clinical efficacy will also be examined, and cost-analysis to determine the economic feasibility of a commercial implementation of RehabGym at home in the future will be performed.
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.
ReHandyBot is the portable version of ReHapticKnob a robot developed at ETH Zurich that provides neurocognitive therapy, focusing on hand opening and closing movements as well as prono-supination of the forearm.
MyoPanda is a passive wrist/hand device which patients use to train the hand and wrist function by controlling a virtual avatar with EMG activity measures.
Time frame: Through study's data collection period, up to 2 years.
Using cloud data from vendor, time (min/hours) of robot (H-Man, ReHandyBot, MyoPanda) usage
Time frame: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum 0, maximum 66, with higher scores indicating better function
Time frame: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function
Time frame: Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment))
For evaluation of the different robots' (H-Man, ReHandyBot, MyoPanda) perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Time frame: Weeks 0 (baseline), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.
Time frame: Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment)
Measures unilateral gross manual dexterity.
Contact information is provided by the study sponsor or research team.
Tan Tock Seng Hospital
Other
Home RehabGym: a Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke
Acronym: Home RehabGym
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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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