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

Effects of Robotic Glove Hand Training on Fine and Gross Motor Function and Activities of Daily Living in Patients After Median Nerve Transfer

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

Study Overview

• Status: Recruiting
• Conditions: Median Nerve Injury
• Intervention / Treatment: Other: Robot Glove Hand Training; Other: Conventional Hand Rehabilitation Exercises

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 (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

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iqbal Tariq, PhD; Phone Number: 03458236752; Email: iqbal.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Ghurki Trust Teaching Hospital , Lahore
      • Contact: Sabiha Arshad, Mphil; Phone Number: 03248495979; Email: s.arshad@riphah.edu.pk
      • Sub-Investigator: Ayesha Kousar, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 .	Other: 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.; 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.
Active Comparator: 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 .	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
THE SOLLERMAN HAND FUNCTION TEST (SHT)	Sollerman Hand Function Test (SHT) is an assessment tool for analyzing hand function and grip strength after hand surgery for recording the recovery rate in rehabilitation phase. The scale include 8 hand grips that further divided into 20 subsets that helps in analyzing hand grip pattern that used for daily activities. Further; each activity was scored form 0 to 4 points with collective score of 80. The lower the score the poor hand function and grip strength was observed. SHT considered as most reliable and valid tool in analyzing hand function with excellent inter-rater reliability (ICC:0.987) and moderate test-retest reliability.	6 Weeks
JABSEN-TAYLER HAND FUNCTION TEST	Jabsen-Tayler Hand Function Test is an effective assessment tool in analyzing fine and gross motor activity of hand that are required for performing daily activities of life. The scale included 7 subsets of activities including writing; turning page, lifting objects; feeding and sacking. It is considered as good to excellent reliable and valid tool with the ICC of 0.77 in dominant hand and 0.84 to 0.97 in non-dominant hand in injured hand.Higher score means worse outcome and Lower score means good outcome.	6 Weeks
PEGBOARD TEST	Pegboard Test is a valid instrument that used for assessing hand dexterity movement.Higher score means worse outcome and Lower score means good outcome. among the individual. It is a test board having five subsets focusing placing pins, bimanual task performance and mathematical problems. The whole test is scored based on the completion of each subset. It has an excellent validity with ICVI= 0.9-1.0, SCVI = 0.93-0.95 and ICCs =0.76-0.85.	6 Weeks
The Original Barthel Index for Activities of Daily Living (ADLs)	The Barthel Index (BI) measures the extent to which somebody can function Independentlybladder control, toileting, chair transfer, ambulation and stair climbing. Items are weighted according to the level of nursing care required and are rated in terms of whether individuals can perform activities independently, with some assistance, or are dependent (scored as 10, 5 or 0). It has 0.89 test-retest reliability and 0.95 internal reliability. Reliability study found an alpha Cronbach value of 0.90 for the complete scale.(30)Higher the score for barthal index it means good outcome and lower the score means poor outcome.	6 Weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sabiha Arshad, Mphil, Riphah International University

Publications and helpful links

General Publications

• Geuna S, Raimondo S, Ronchi G, Di Scipio F, Tos P, Czaja K, Fornaro M. Chapter 3: Histology of the peripheral nerve and changes occurring during nerve regeneration. Int Rev Neurobiol. 2009;87:27-46. doi: 10.1016/S0074-7742(09)87003-7.
• Rydevik B, Lundborg G. Permeability of intraneural microvessels and perineurium following acute, graded experimental nerve compression. Scand J Plast Reconstr Surg. 1977;11(3):179-87. doi: 10.3109/02844317709025516.
• George SC, Burahee AS, Sanders AD, Power DM. Outcomes of anterior interosseous nerve transfer to restore intrinsic muscle function after high ulnar nerve injury. J Plast Reconstr Aesthet Surg. 2022 Feb;75(2):703-710. doi: 10.1016/j.bjps.2021.09.072. Epub 2021 Oct 22.
• Liu Y, Lao J, Gao K, Gu Y, Xin Z. Outcome of nerve transfers for traumatic complete brachial plexus avulsion: results of 28 patients by DASH and NRS questionnaires. J Hand Surg Eur Vol. 2012 Jun;37(5):413-21. doi: 10.1177/1753193411425330. Epub 2011 Nov 8.
• Yurkewich A, Kozak IJ, Ivanovic A, Rossos D, Wang RH, Hebert D, Mihailidis A. Myoelectric untethered robotic glove enhances hand function and performance on daily living tasks after stroke. J Rehabil Assist Technol Eng. 2020 Dec 15;7:2055668320964050. doi: 10.1177/2055668320964050. eCollection 2020 Jan-Dec.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hand Rehabilitation; Nerve transfer Rehabilitation; Robotic Glove
• Other Study ID Numbers: REC/RCR&AHS/23/02103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No