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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05356442
Recruitment Status : Completed
First Posted : May 2, 2022
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease
Spinal Cord Injuries

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.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Association of Tenodesis Grip Strength With Functional Hand Recovery in Patients With Cervical Spinal Cord Injury
Actual Study Start Date : April 25, 2022
Actual Primary Completion Date : December 25, 2022
Actual Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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).

  4. 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.



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
SCI
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05356442


Locations
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Pakistan
Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Tehreem Mukhtar Riphah International University
Publications:
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05356442    
Other Study ID Numbers: REC/Lhr/22/0209 Amna Ali
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
spinal cord injury, pain ,tenodesis grip, strength
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System