Viewing Study NCT06406569



Ignite Creation Date: 2024-05-11 @ 8:31 AM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06406569
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-10
First Post: 2024-05-06

Brief Title: A Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke
Sponsor: Tan Tock Seng Hospital
Organization: Tan Tock Seng Hospital

Study Overview

Official Title: Home RehabGym a Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Home RehabGym
Brief Summary: 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
Detailed Description: 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 patients 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None