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

July 18, 2023 updated by: Riphah International University

Effects of Functional Electrical Stimulations With and Without Motor Priming Exercises on Tenodesis Grip in Patients With Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Lahore General 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

Ages Eligible for Study

11 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6th week
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
6th week
The American Spinal Injury Association Impairment Scale
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
6th week
Graded redefined assessment for sensation, strength and prehension 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(
6th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal Cord Independence Measure
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
6th weeks

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Binash Afzal, PHD*, Riphah International University Lahore Campus

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)

March 15, 2022

Primary Completion (Actual)

September 20, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/22/0214

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.

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