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

NCT05863988 | Unknown

• 1 other identifier: REC/LHR/23/0214 Aroosa
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Dexterity,Functional Electrical Stimulation,Hand Function

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Functional Electrical Stimulation &upper limb loading exercises

ACTIVE COMPARATOR

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

Functional Electrical Stimulation & Upper Limb Loading Exercises

ACTIVE COMPARATOR

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

Interventions

Functional Electrical Stimulation OTHER

The group A will receive functional electrical stimulation 30-45 min session 5 days per week for 8 weeks.

Functional Electrical Stimulation &upper limb loading exercises

Upper Limb Loading Exercises OTHER

The group B will receive Upper Limb Loading Exercises 30-45 min session 5 days per week for 8 weeks.

Functional Electrical Stimulation & Upper Limb Loading Exercises

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bahawal Victoria Hospital Bahawalpur

Chak Four Hundred Fifty-four, Punjab Province, Pakistan

RECRUITING

Related 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.

  PMID: 15672628 BACKGROUND

• 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.

  PMID: 15673842 BACKGROUND

• 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.

  PMID: 27053214 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Hira jabeen, MS NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Jabeen, MS NMPT

CONTACT

03234116506; hira.jabeen@riphah.edu.pk

Aroosa Razaq, DPT

CONTACT

03070079835; arosad556@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: February 25, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 30, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)