Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459908
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-11
Brief Title:
Effects of Robotic Glove Hand Training in Patients After Median Nerve Transfer
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Effects of Robotic Glove Hand Training on Fine and Gross Motor Function and Activities of Daily Living in Patients After Median Nerve Transfer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
Selective nerve transfers provide an opportunity for restoring the motor function after nerve injuries Upper-limb robot-assisted therapy has been established as a safe and feasible treatment to complement rehabilitation after neurological injury The aim of this study is to explore the combined effects of Hand Training with Robotic Glove on fine and gross motor function and activities of daily living in patients after median nerve transfer The study will be randomized controlled trial Participants will be recruited through non probability convenience sampling technique After screening for eligibility participants will be randomly assigned by balanced pre-randomization into two groups either to a robot-assisted group RG participants of this group receiving robot-assisted Hand Rehabilitation with the Syrebo Robotic Gloves or to a control group CG receiving dose-matched conventional Hand Rehabilitation without the robot Participants will be engaged in exercises 4 times a week for 6 weeks each participants will receive 3 Hand Rehabilitation therapy sessions of 45 Mins per day focusing on hand function Data will be assessed at the start of the 1st session and at the end of the last session after 6 weeks with the help of Sollerman Hand Function test Jebsen Taylor Hand Function test The Original Barthel Index for Activities of Daily living Data will be analyzed using SPSS version 25
Detailed Description:
Selective nerve transfers provide an opportunity for restoring the motor function after nerve injuries Over the past decade different hand rehabilitation protocols and exercises are developed robotic assisted rehabilitation is one of them Upper-limb robot-assisted therapy has been established as a safe and feasible treatment to complement rehabilitation after neurological injury Robots can precisely control the interaction with the user eg supporting or resisting in an assist-as-needed manner and render virtual environments both visually and mechanically making them ideal tools for sensorimotor training providing engaging and challenging therapy The aim of this study is to explore the combined effects of Hand Training with Robotic Glove on fine and gross motor function and activities of daily living in patients after median nerve transfer The study will be randomized controlled trial Participants will be recruited through non probability convenience sampling technique After screening for eligibility participants will be randomly assigned by balanced pre-randomization into two groups either to a robot-assisted group RG participants of this group receiving robot-assisted Hand Rehabilitation with Syrebo Robotic Gloves or to a control group CG receiving dose-matched conventional Hand Rehabilitation without the robot The participants will be engaged in exercises 4 times a week for 6 weeks each participants will receive three Hand Rehabilitation therapy sessions per day focusing on hand function Each therapy session will be of 45 minutes These sessions will be embedded in the weekly therapy plan for each individual participant Data will be assessed at the start of the 1st session and at the end of the last session after 6 weeks with the help of Sollerman Hand Function test Jebsen Taylor Hand Function test The Original Barthel Index for Activities of Daily living Data will be analyzed using SPSS version 25 Key words Hand Rehabilitation Nerve transfer Rehabilitation Robotic Glove
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