Clinical trial NCT06459908: Effects of Robotic Glove Hand Training in Patients After Median Nerve Transfer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Median Nerve Injury
Keywords: Hand Rehabilitation
Nerve transfer Rehabilitation
Robotic Glove
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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

Eligibility criteria: 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

Primary outcomes:
measure: THE SOLLERMAN HAND FUNCTION TEST (SHT)
timeFrame: 6 Weeks
measure: JABSEN-TAYLER HAND FUNCTION TEST
timeFrame: 6 Weeks
measure: PEGBOARD TEST
timeFrame: 6 Weeks
measure: The Original Barthel Index for Activities of Daily Living (ADLs)
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurki Trust Teaching Hospital , Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.