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

NCT ID: NCT05863988

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2023-10-30

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Functional Electrical Stimulation

Intervention Type 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

The group B will receive upper limb loading exercises and conservative treatment 30-45 min session 5 days per week for 8 weeks.

Group Type ACTIVE_COMPARATOR

Upper Limb Loading Exercises

Intervention Type OTHER

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

Interventions

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Functional Electrical Stimulation

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hira jabeen, MS NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Bahawal Victoria Hospital Bahawalpur

Chak Eighty-seven -Twelve Left, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Hira Jabeen, MS NMPT

Role: CONTACT

03234116506

Aroosa Razaq, DPT

Role: CONTACT

03070079835

References

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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.

Reference Type BACKGROUND
PMID: 15672628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15673842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27053214 (View on PubMed)

Other Identifiers

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REC/LHR/23/0214 Aroosa

Identifier Type: -

Identifier Source: org_study_id

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