Clinical trial NCT05863988: FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients
Official title: Effects Of Functional Electrical Stimulation Versus Upper Limb Loading Exercises on Grip Strength,Dexterity and Function in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Dexterity,Functional Electrical Stimulation,Hand Function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to assess the effectiveness of functional electrical stimulation Vs limb loading exercises on hand grip strength,dexterity and function in patients with subacute cervical spinal cord injury.

Detailed description: Spinal cord injury (SCI) is based on the concept that rehabilitative training recruits neuronal systems spinal cord injury that remain intact after the injury to take over the impaired function.Working in the field of rehabilitation of the spinal cord injured, presents many challenges. Every patient presents a new and specific challenge. The tetraplegics more so than the paraplegics as the result of loss of active function of their upper extremities in addition to loss of function in the trunk and lower extremities. This study will be conducted to assess the effects of functional electrical stimulation versus limb loading exercises on hand grip strength,dexterity and function in patients with subacute spinal cord injury.

trength,dexterity and function in patients with subacute spinal cord injury. The study will be randomized clinical trial. Participants will be randomly allocated in to two groups each group will have ten participants.. This study will be conducted in two Hospitals in Punjab pakistan. The group A Will receive functional electrical stimulation .The group B will receive upper limb loading exercises .Both groups will be given 30-45 min session 5 days per week for 8 weeks. The outcomes will be measured before and after giving treatment by using modified Action Research Arm Test (ARAT),Hand held dynamometry , Nine-Hole Peg Test (9HPT). The results will be calculated by using SPSS 23 version . Statistical tests will be applied according to the normality of the data either it will be parametric or non-parametric.

Eligibility criteria: Inclusion Criteria:

* Patients with incomplete SCI at neurological level C5-T1 in subacute stage.
* Medically stable
* Able to tolerate the Functional Electrical stimulation without sustained autonomic dysreflexia
* A score greater than 16 in mini-mental test

Exclusion Criteria:

* Patients taking long term steroids
* patient having pre-existing injury on upper limb or hand
* Patients have had Previous participation in experimental trial for spinal cord injury
* Patients using Currently cardioactive medications
* Individuals who has had Tendon transfers, implanted devices bladder stimulation, chronic intrathecal infusions
* Individuals with Bleeding disorders.
* Amputation of any digit on target hand

Primary outcomes:
measure: Modified Action Research Arm Test
timeFrame: 8th week
measure: Hand Held Dynamometry
timeFrame: 8th week
measure: 9 peg hole test
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: Bahawal Victoria Hospital Bahawalpur
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hira jabeen, MS NMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
citation: Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
citation: Hilton BJ, Anenberg E, Harrison TC, Boyd JD, Murphy TH, Tetzlaff W. Re-Establishment of Cortical Motor Output Maps and Spontaneous Functional Recovery via Spared Dorsolaterally Projecting Corticospinal Neurons after Dorsal Column Spinal Cord Injury in Adult Mice. J Neurosci. 2016 Apr 6;36(14):4080-92. doi: 10.1523/JNEUROSCI.3386-15.2016.