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

Riphah International University

Status: Enrolling

Conditions: Median Nerve Injury

Treatments: Other: Robot Glove Hand Training; Other: Conventional Hand Rehabilitation Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06459908

REC/RCR&AHS/23/02103

Details and patient eligibility

About

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

Full 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 (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

Enrollment: 46 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Robot-assisted group (RG)

Experimental group

Description:

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 .

Treatment:

Other: Conventional Hand Rehabilitation Exercises

Other: Robot Glove Hand Training

conventional hand rehabilitation exercises

Active Comparator group

Description:

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 .

Treatment:

Other: Conventional Hand Rehabilitation Exercises