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

March 31, 2023 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SCI

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
Time Frame: 8 months
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)
Time Frame: 8 months
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
Time Frame: 8 months
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
Time Frame: 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tehreem Mukhtar, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/Lhr/22/0209 Amna Ali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings