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Spinal Cord InjuriesNCT05356442

Tenodesis Grip Strength With Functional Hand Recovery in Cervical Spinal Cord Injury

An observational study of Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
How many people
70 participants
Where
1 sitePakistan
Study dates
25 Apr 2022to 30 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: SCI

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Association of Tenodesis Grip Strength With Functional Hand Recovery in Patients With Cervical Spinal Cord Injury

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.

Read the detailed description

Spinal cord injury (SCI) is important area for research, because of planning the services for the disabled and also decisions making for the prevention and control of SCI. Spinal cord injury (SCI) is a highly destructive and damaging condition with enormous financial, social, and personal costs. As, there is no known cure for SCI. so, primary prevention is a necessary. Due to high incidence of road traffic accidents, epidemiologic data concerning that, it is the specific causes of spinal cord injury and the other causes of spinal cord injury Traumatic including transport, fall, diving in shallow water, other may be non- traumatic including iatrogenic. So, the understanding of this is important due to preventive strategies and for planning better treatment and cure. The most devastating aspects of spinal cord injury are Quadriplegia because it is the impairment of arm and hand function, which badly affect the individual's level of independence. Improving arm and hand function has been reported to be a high priority for individuals with SCI.As, the hand function change with neurological level of lesion specially in cervical spinal cord injury. In which hand function is almost completely loss above C5 and below C7 cord lesion the upper limb functions almost preserved. The high priority is preserved hand function due to personal independence and improve the quality of life. Tenodesis function is used to facilitate the functional hand grasp and release by adjusting the position of wrist in tetraplagic peoples. When the wrist flexed, fingers and thumb open and when the wrist extended, fingers and thumb flexed into palm. It is possible for those who have wrist extension in grade 3 and no active movement of fingers Tenodesis grasp is useful for C6-C7 spinal cord injury because they have control on wrist movement and limited finger control. So they can easily grasp and release objects than those who have no or limited control over their hands. That is helpful for their ADLs. Functional hand recovery or hand strength in Quadriplegia is improved with repetitive active or passive ROM. The above and below the spinal level of lesion. Hand grip devices also used for improving the grip strength and hand function in SCI.According to searched data no study conducted to describe the association between the functional hand recovery with reference to neurological lesion level of cervical spinal cord injury and tenodesis grip strength. To find out the association between the tenodesis grip and functional hand recovery in patient with cervical spinal cord injury.

Keywords
spinal cord injury, pain ,tenodesis grip, strength
Medical subject headings
Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 months

  2. 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

    Measured: 8 months

  3. 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).

    Measured: 8 months

  4. 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.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start25 Apr 2022
  3. Primary completion25 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05356442
Sponsor's protocol ID
REC/Lhr/22/0209 Amna Ali
Status last verified
Mar 2023
First submitted
28 Apr 2022
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 15326472

  • 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.

    PubMed 19777865

  • 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.

    PubMed 29789707

  • 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.

    PubMed 23820875

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05356442, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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