FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients

Spinal Cord Injuries Clinical Trial

— OCONHAND  

Official title:

Effects Of Functional Electrical Stimulation Versus Upper Limb Loading Exercises on Grip Strength,Dexterity and Function in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863988
• Other study ID #: REC/LHR/23/0214 Aroosa
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2023
• Source: Riphah International University
• Contact: Hira Jabeen, MS NMPT
• Phone: 03234116506
• Email: hira.jabeen[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Functional Electrical Stimulation
The group A will receive functional electrical stimulation 30-45 min session 5 days per week for 8 weeks.
• Upper Limb Loading Exercises
The group B will receive Upper Limb Loading Exercises 30-45 min session 5 days per week for 8 weeks.

Locations

Country	Name	City	State
Pakistan	Bahawal Victoria Hospital Bahawalpur	Bahawalpur	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Action Research Arm Test	The ARAT has excellent reliability and low ceiling effects. It consists of 4 subtests, including grasp, grip, pinch, and gross movement. All tasks were scored on a 4-point scale from 0 to 3, where 0 reflects poor hand function and 3 reflects good hand function (maximum score, 57).	8th week
Primary	Hand Held Dynamometry	A small portable device is held by the examiner and placed against the patient's limb .during a maximal isometric contraction. The device can be used to test hand muscle strength efficiently	8th week
Primary	9 peg hole test	Nine-Hole Peg Test is administered by asking the client to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container.. The number of seconds it takes for the patient to complete the test.	8th week