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

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Functional Electrical Stimulation
Upper Limb Loading Exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Dexterity,Functional Electrical Stimulation,Hand Function

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bahawal Victoria Hospital BahawalpurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Functional Electrical Stimulation &upper limb loading exercises

Functional Electrical Stimulation & Upper Limb Loading Exercises

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2023
Last Updated
May 9, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05863988
Brief Title
FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Dexterity,Functional Electrical Stimulation,Hand Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional Electrical Stimulation &upper limb loading exercises
Arm Type
Active Comparator
Arm Description
The group A Will receive functional electrical stimulation and conservative treatment 30-45 min session 5 days per week for 8 weeks.
Arm Title
Functional Electrical Stimulation & Upper Limb Loading Exercises
Arm Type
Active Comparator
Arm Description
The group B will receive upper limb loading exercises and conservative treatment 30-45 min session 5 days per week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
The group A will receive functional electrical stimulation 30-45 min session 5 days per week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Upper Limb Loading Exercises
Intervention Description
The group B will receive Upper Limb Loading Exercises 30-45 min session 5 days per week for 8 weeks.
Primary Outcome Measure Information:
Title
Modified Action Research Arm Test
Description
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).
Time Frame
8th week
Title
Hand Held Dynamometry
Description
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
Time Frame
8th week
Title
9 peg hole test
Description
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.
Time Frame
8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hira Jabeen, MS NMPT
Phone
03234116506
Email
hira.jabeen@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Aroosa Razaq, DPT
Phone
03070079835
Email
arosad556@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira jabeen, MS NMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahawal Victoria Hospital Bahawalpur
City
Bahāwalpur
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aroosa Razaq, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15672628
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.
Results Reference
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PubMed Identifier
15673842
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.
Results Reference
background
PubMed Identifier
27053214
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.
Results Reference
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FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients

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