Effects of Robotic Glove Hand Training in Patients After Median Nerve Transfer
NCT Number: NCT06459908
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Median Nerve Injury
Interventions: OTHER: Robot Glove Hand Training|OTHER: Conventional Hand Rehabilitation Exercises
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-10
Completion Date: 2024-07-10
Locations: Ghurki Trust Teaching Hospital , Lahore, Lahore, Punjab, 54000, Pakistan

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

Primary Outcome Measures: 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