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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Functional Electrical Stimulation; Other: Upper Limb Loading Exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hira Jabeen, MS NMPT; Phone Number: 03234116506; Email: hira.jabeen@riphah.edu.pk
• Study Contact Backup: Name: Aroosa Razaq, DPT; Phone Number: 03070079835; Email: arosad556@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Bahāwalpur, Punjab, Pakistan
      • Recruiting
      • Bahawal Victoria Hospital Bahawalpur
      • Principal Investigator: Aroosa Razaq, DPT

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Functional Electrical Stimulation &upper limb loading exercises; The group A Will receive functional electrical stimulation and conservative treatment 30-45 min session 5 days per week for 8 weeks.	Other: Functional Electrical Stimulation; The group A will receive functional electrical stimulation 30-45 min session 5 days per week for 8 weeks.
Active Comparator: Functional Electrical Stimulation & Upper Limb Loading Exercises; The group B will receive upper limb loading exercises and conservative treatment 30-45 min session 5 days per week for 8 weeks.	Other: Upper Limb Loading Exercises; The group B will receive Upper Limb Loading Exercises 30-45 min session 5 days per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Hira jabeen, MS NMPT, Riphah International University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2023
• Primary Completion (Anticipated): October 18, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Dexterity,Functional Electrical Stimulation,Hand Function
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: REC/LHR/23/0214 Aroosa

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