NCT05356442

Brief Summary

Spinal cord injury (SCI) is devastating event, the individual become significant burden on their family and society SCI is impairments of sensory, motor and autonomic functions. There is no proper cure and care after SCI, no proper assessment and treatment is present in under developed countries Cross sectional study design will be used and 75 patients included in this study. The population included age 21-55 years, both gender included, teraplegic with lesion level C5-C7, Mini Mental State of Examination ≥24, patient should be medically stable. The patient excluded with history of peripheral nerve lesion as brachial pluxes impairment. For assessment of hand function tools should be used tenodesis grip strength is assessed Graded Redefined Assessment of Strength sensibility and prehension (GRASSP test), and functional hand recovery assessed by jebsen\_Taylor Hand function test (JTHFT\_IT), hand dynamo meter for grip strength, Action Arm reach test for hand function and spinal cord independence measure will be used. Pearson correlation will be uses to find the association between hand grip strength and functional activities of hand. The collected data will be analyzed by using SPSS 23.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

April 28, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

spinal cord injury, pain ,tenodesis grip, strength

Outcome Measures

Primary Outcomes (4)

  • Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)

    GRASSP is a clinical research tool for sensory and motor impairment data of upper limb in cervical spinal cord injury. GRASSP have three components, first is sensibility domain test site is selected by dermatome, second is strength and tone domain in which muscle tested by myotomes and third is prehension domain in which segmental influence movement pattern

    8 months

  • Jebsen-Taylor hand function test (JTHFT-IT)

    JTHFT-IT is used in people with tetraplegia. This scale is used for assessment of arm and hand , including basic functions as moving objects in which turning and pick up small objects , lifting small objects and light weighted objects also grasp and release including complex functions as dress up and toileting. The maximum time for execution of seven items will be 14min since the maximum execution time for each item is 120s

    8 months

  • Hand Grip Dynamometer Strength Tool

    It is used in correct position of arm and hand can vary in different grip strength, both for right and left hand will be accessed and scoring start from dominant hand. Interpretation for male in Ib and in( kg), poor in 88-95(Ib) and 40-43kg, average strength 105-114 in (Ib) and 48-51 in( kg) while good strength in 123-141(Ib) and 56-64(kg). and in females values are different poor strength 44-48(ib) and 34-38(kg) , average strength value will be 57-65(ib) and in 26-29 in (kg), while good strength rating is 75-84(ib) and 34-38(kg).

    8 months

  • Spinal Cord Independence Measure

    There are basically three subscales. First is self care and also for hand function assessment in which 0-4 items and score is 0-20, second is respiration and sphincter management 5-8 items and score is 0-40 while third is mobility with 9-18 items and score is 0-40. Total score is 100 while total items are 19 and assessment completed in 30-45minutes.

    8 months

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

SCI

You may qualify if:

  • Age group is from 21 to 55 years.
  • Both male and female
  • Tetraplegic with neurological lesion level C5-C7
  • Mini Mental State Examination ≥24
  • Grade C and D will include in this study according to ASIA impairment scale
  • Upper limb muscles in grade 0, 1, +1 according to modified Ashworth scale

You may not qualify if:

  • Contracture of upper extremity with C5-C7 cervical SCI.
  • Combined peripheral or central nervous system disease
  • History of peripheral nerve lesion as brachial plexus impairment
  • Previously known poly Neuropathy or sever cranio cerebral injury
  • History of Fracture or any surgical procedure in hand area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • O'Connor PJ. Prevalence of spinal cord injury in Australia. Spinal Cord. 2005 Jan;43(1):42-6. doi: 10.1038/sj.sc.3101666.

    PMID: 15326472BACKGROUND
  • Rahimi-Movaghar V, Saadat S, Rasouli MR, Ganji S, Ghahramani M, Zarei MR, Vaccaro AR. Prevalence of spinal cord injury in Tehran, Iran. J Spinal Cord Med. 2009;32(4):428-31. doi: 10.1080/10790268.2009.11754572.

    PMID: 19777865BACKGROUND
  • Jung HY, Lee J, Shin HI. The natural course of passive tenodesis grip in individuals with spinal cord injury with preserved wrist extension power but paralyzed fingers and thumbs. Spinal Cord. 2018 Sep;56(9):900-906. doi: 10.1038/s41393-018-0137-4. Epub 2018 May 22.

    PMID: 29789707BACKGROUND
  • Thorsen R, Binda L, Chiaramonte S, Dalla Costa D, Redaelli T, Occhi E, Beghi E, Ferrarin M. Correlation among lesion level, muscle strength and hand function in cervical spinal cord injury. Eur J Phys Rehabil Med. 2014 Feb;50(1):31-8. Epub 2013 Jul 2.

    PMID: 23820875BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Tehreem Mukhtar

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 2, 2022

Study Start

April 25, 2022

Primary Completion

December 25, 2022

Study Completion

December 30, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations