Effects of Robotic Glove Hand Training in Patients After Median Nerve Transfer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2024-07-10

Brief Summary

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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

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Detailed Description

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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 (e.g., 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

Conditions

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Median Nerve Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Robot-assisted group (RG)

Patients in group A will perform these exercises while Wearing robotic hand-training gloves. Group A will perform hand exercises with the help of robotic glove assistance for 3 times per day/ 4 times per week, 45 minutes per session for 6 consecutive weeks, Number of total sessions will be 72 .

Group Type EXPERIMENTAL

Robot Glove Hand Training

Intervention Type OTHER

Robot Assisted group will perform hand exercises with the help of robotic glove assistance for 3 times per day/ 4 times per week, 45 minutes per session for 6 consecutive weeks. Total Number of Sessions will be 72 Hours.

Conventional Hand Rehabilitation Exercises

Intervention Type OTHER

Conventional therapy group will perform hand exercises without the help of robotic gloves 3 times per day/ 4 times per week, 45 minute session for 6 consecutive weeks.Total number of sessions will be 72.

conventional hand rehabilitation exercises

The control group will receive the same treatment as Robot Assisted group but without any robot-assisted device.Group B will perform hand exercises without the help of robotic glove for 3 times per day/ 4 times per week, 45 minute session for 6 consecutive weeks.Number of total sessions will be 72 .

Group Type ACTIVE_COMPARATOR

Conventional Hand Rehabilitation Exercises

Intervention Type OTHER

Conventional therapy group will perform hand exercises without the help of robotic gloves 3 times per day/ 4 times per week, 45 minute session for 6 consecutive weeks.Total number of sessions will be 72.

Interventions

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Robot Glove Hand Training

Robot Assisted group will perform hand exercises with the help of robotic glove assistance for 3 times per day/ 4 times per week, 45 minutes per session for 6 consecutive weeks. Total Number of Sessions will be 72 Hours.

Intervention Type OTHER

Conventional Hand Rehabilitation Exercises

Conventional therapy group will perform hand exercises without the help of robotic gloves 3 times per day/ 4 times per week, 45 minute session for 6 consecutive weeks.Total number of sessions will be 72.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Both Genders will be recruited
* Age between 19 to 55 years
* Median nerve transfer after traumatic event (RTA, history of Fall, avulsion, compression or stretch injuries)
* The ability to follow and respond to verbal commands

Exclusion Criteria

subjects will be excluded if they have

* Altered state of consciousness,
* Aphasia ,
* Severe cognitive deficits .
* Severe pathologies of upper limb of rheumatic nature
* Could not provide informed consent for study
* Severe pain in affected arm Visual analogue scale \> 5

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No