Clinical trial NCT05356442: Tenodesis Grip Strength With Functional Hand Recovery in Cervical Spinal Cord Injury
Official title: Association of Tenodesis Grip Strength With Functional Hand Recovery in Patients With Cervical Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury, pain ,tenodesis grip, strength
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCI

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.

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.

Eligibility 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.

Primary outcomes:
measure: Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
timeFrame: 8 months
measure: Jebsen-Taylor hand function test (JTHFT-IT)
timeFrame: 8 months
measure: Hand Grip Dynamometer Strength Tool
timeFrame: 8 months
measure: Spinal Cord Independence Measure
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tehreem Mukhtar
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor PJ. Prevalence of spinal cord injury in Australia. Spinal Cord. 2005 Jan;43(1):42-6. doi: 10.1038/sj.sc.3101666.
citation: 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.
citation: 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.
citation: 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.