Clinical trial NCT05411692: Functional Electrical Stimulations With and Without Motor Priming Exercises in Spinal Cord Injury
Official title: Effects of Functional Electrical Stimulations With and Without Motor Priming Exercises on Tenodesis Grip in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 26
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As functional electrical stimulations has evident role in improving motor control in tenodesis function (power and precision grip) but its results are considered to be short term so addition of task oriented approach i.e. motor priming exercises could enhance the treatment effects . Priming is a mechanism that could easily be a part of a restorative occupational therapy approach, is a therapeutic method with the intent to improve function by targeting underlying neural mechanisms (neuroplasticity and motor control). This will yield the long term effects of priming augmented functional electrical stimulations to enhance the tenodesis function of patients with spinal cord injury. Their combination may produce improvement in hand functions dexterity in spinal cord injury patients.

Detailed description: Spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in or loss of muscle function, sensation, or autonomic function in the parts of the body served by the spinal cord, below the level of the injury. People with Spinal cord injury (C6-7 tetraplegia) are often lacking grip strength, causing impairment in activities of daily living. Variety of physiotherapy approaches such as electrical stimulations and different exercise regimes has been used in rehabilitation program of spinal cord injuries. Functional electrical impulses apply to nerves and muscles to restore muscle function in people with spinal cord injury. Second, priming of the motor cortex with motor priming exercises is associated with neuroplastic changes and improved motor performance.

This will be a randomized control trail and the study aims to determine which group will show better results of functional electrical stimulations with or without motor priming exercise on tenodesis grip in sub acute spinal cord injury patients. Evidences support that, in more than 40 years of functional electrical stimulation research, principles for safe stimulation of neuromuscular tissue have been established; it has been developed for restoring function in the upper extremity, lower extremity, bladder and bowel, and respiratory system. Paralyzed or paretic muscles can be made to contract by applying

electrical currents to the intact peripheral motor nerves innervating them. When electrically elicited muscle contractions are coordinated in a manner that provides function, the technique is termed functional electrical stimulation (FES)

Another approach is Motor priming, which is receiving considerable attention as a way of augmenting the effects of rehabilitation-related training in neurologic clinical populations. Much of the early work related to motor priming to improve hand function in persons with tetraplegia) Priming is a non-conscious process associated with learning where exposure to a stimulus alters the response of another stimulus. When used successfully in conjunction with a therapeutic intervention, priming results in a behavior change coinciding with changes in neural processes. Motor priming exercises demonstrate changes in cortical excitability, or facilitate cognitive processing, thus inducing neuroplastic effects such as release of neurochemicals that may enhance the effect of subsequent training. Priming that target the motor cortex is a relatively new topic of research in the fields of motor control and rehabilitation

This will be a randomized control trial and patients will be recruited through convenient sampling into three groups. Group A will be given functional electrical stimulations with motor priming exercises. Group B will be receiving functional electrical stimulations alone and group C will receive conventional exercises training. Pre and post measurements with outcome measuring tool will be taken. Tools for accessing tenodesis grip will be hand dynamometer, pinch meter, Manual Muscle Testing, graded redefined assessment of sensation , strength and pretension; GRASSP tool, Spinal Cord Independence Measure SCIM- self care sub score . The data will be analyzed using SPSS 25 software.

Eligibility criteria: Inclusion Criteria:

* Both male and female with age group (15 50)
* Patient with C6-C7 neurological level of injury
* Patient with incomplete ASIA- D grading
* Clinically stable patients with normal vital signs and mental status
* Patient in acute and sub-acute stage ( usually \< 18 months post injury
* Patients without active palmer and lateral grasp function (except tenodesis grasp function)
* Patients having intact wrist extensors in Grade 3 or higher manual muscle test i.e. can perform tenodesis action

Exclusion Criteria:

* Patients with Neurological level of injury C8 or above
* Patient with chronic stage \> 18 months
* Patients with Spastic hands
* Patients with implants in body
* Patients with history of Epilepsy
* Patients with Cardiovascular problems

Primary outcomes:
measure: Hand Dynamometer
timeFrame: 6th week
measure: Pinch meter
timeFrame: 6th week
measure: The American Spinal Injury Association Impairment Scale
timeFrame: 6th week
measure: Graded redefined assessment for sensation, strength and prehension tool
timeFrame: 6th week
Secondary outcomes:
measure: Spinal Cord Independence Measure
timeFrame: 6th weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore general Hospital
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Binash Afzal, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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