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Functional Electrical Stimulations With and Without Motor Priming Exercises in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT05411692
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Functional electrical stimulations and motor priming exercise Other: Functional electrical stimulations Other: Conventional physical therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Functional Electrical Stimulations With and Without Motor Priming Exercises on Tenodesis Grip in Patients With Spinal Cord Injury
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional electrical stimulations and motor priming exercise
Functional electrical stimulations and motor priming exercise • Palmar Grasp (holding a ball) of Lateral Grasp (holding a tray),Tripod grip (thumb, index, and middle finger: holding a pen), Two finger opposition (thumb and index finger: holding a peg, Lateral Pinch (thumb and index finger: holding a credit card), lateral pinch, two fingers (index and middle finger: smoker's grip
Other: Functional electrical stimulations and motor priming exercise

One pair of surface stimulation electrodes is placed on the subject's skin above the flexor digitorum superficialis and the flexor digitorum profundus muscles to generate finger flexion. The Second pair of electrodes is placed on the subject's skin, above the median

nerve, to generate thumb flexion. The third pair of electrodes is placed on the subject's skin, above the extensor digitorum muscle, to generate finger extension. Motor priming exercises will be done (functional task practice, FTP) for 20 minutes. Participants will be asked to spend at least 20 minutesDuration of training will be 4 weeks, 5 days per week, one session per day, and one hour per session.


Active Comparator: Functional electrical stimulations
Stimulation parameters are (1) balanced, biphasic, current-regulated electrical pulses; (2) pulse amplitude from 8 to 50 mA (typical values 17- 26 mA); (3) pulse width 250 ms; and (4) pulse frequency from 20 to 70 Hz (18). Trancutaneous stimulation will be delivered bilaterally with surface electrodes placed on the volar aspect of each wrist targeting the distribution of the median nerve
Other: Functional electrical stimulations

Stimulation parameters are (1) balanced, biphasic, current-regulated electrical pulses; (2) pulse amplitude from 8 to 50 mA (typical values 17- 26 mA); (3) pulse width 250 ms; and (4) pulse frequency from 20 to 70 Hz (18). Trancutaneous stimulation will be delivered bilaterally with surface electrodes placed on the volar aspect of each wrist targeting the distribution of the median nerve. One pair of surface stimulation electrodes is placed on the subject's skin above the flexor digitorum superficialis and the flexor digitorum profundus muscles to generate finger flexion. The Second pair of electrodes is placed on the subject's skin, above the median

nerve, to generate thumb flexion for 20 minutes


Placebo Comparator: Convetional phyusical therapy
The prescription of resistance load for strength training will be performed with fine motor exercise , based on sub maximal repetitions
Other: Conventional physical therapy
a structured exercise protocol targeting strength (2 days/week) and endurance (3days/week) training




Primary Outcome Measures :
  1. Hand Dynamometer [ Time Frame: 6th week ]
    Used to measure grip strength.The patient squeezes the dynamometer with all of their strength, typically three times with each hand. An average score is then calculated using the measurements from both hands

  2. Pinch meter [ Time Frame: 6th week ]
    A pinch meter is a medical instrument that is used to test digital strength in the form of three different types of pinches. It primarily serves as a diagnostic and assessment tool.The therapist takes the average of 3 trials for each type of pinch, alternating from one hand to the other. Positioning during the test should be shoulder adducted, elbow at 90 degrees and forearm in neutral

  3. The American Spinal Injury Association Impairment Scale (ASIA [ Time Frame: 6th week ]
    The American Spinal Injury Association Impairment Scale is a standardized neurological examination used by the rehabilitation team to assess the sensory and motor levels which were affected by the spinal cord injury

  4. Graded redefined assessment for sensation, strength and prehension tool (GRASSP tool) [ Time Frame: 6th week ]
    The GRASSP is a clinical impairment measure used for the upper limb after tetraplegia. The measure includes three domains (sensation, strength , prehension) which are important in describing hand function(


Secondary Outcome Measures :
  1. Spinal Cord Independence Measure (SCIM) [ Time Frame: 6th weeks ]

    The SCIM has been developed to address three specific areas of function in

    patients with spinal cord injury (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities i.e. bed mobility and transfers and indoors/outdoors




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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT05411692


Contacts
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Contact: Imran Amjad, phD 03324390125 imran.amjad@riphah.edu.pk

Locations
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Pakistan
Lahore general Hospital Recruiting
Lahore, Punjab, Pakistan, 54000
Principal Investigator: Laraib Noor, Ms NMPT         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Binash Afzal, PHD* Riphah international university lahore campus
Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05411692    
Other Study ID Numbers: REC/RCR&AHS/22/0214
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
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
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