Functional Electrical Stimulations With and Without Motor Priming Exercises in Spinal Cord Injury
NCT ID: NCT05411692
Last Updated: 2023-07-20
Study Results
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Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2022-03-15
2022-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
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
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
Convetional phyusical therapy
The prescription of resistance load for strength training will be performed with fine motor exercise , based on sub maximal repetitions
Conventional physical therapy
a structured exercise protocol targeting strength (2 days/week) and endurance (3days/week) training
Interventions
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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.
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
Conventional physical therapy
a structured exercise protocol targeting strength (2 days/week) and endurance (3days/week) training
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient with chronic stage \> 18 months
* Patients with Spastic hands
* Patients with implants in body
* Patients with history of Epilepsy
* Patients with Cardiovascular problems
15 Years
50 Years
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Binash Afzal, PHD*
Role: PRINCIPAL_INVESTIGATOR
Riphah international university lahore campus
Locations
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Lahore general Hospital
Lahore, Punjab Province, Pakistan
Countries
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References
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GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):56-87. doi: 10.1016/S1474-4422(18)30415-0. Epub 2018 Nov 26.
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.
Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.
Stoykov ME, Corcos DM, Madhavan S. Movement-Based Priming: Clinical Applications and Neural Mechanisms. J Mot Behav. 2017 Jan-Feb;49(1):88-97. doi: 10.1080/00222895.2016.1250716. Epub 2017 Mar 1.
Vafadar AK, Cote JN, Archambault PS. Effectiveness of functional electrical stimulation in improving clinical outcomes in the upper arm following stroke: a systematic review and meta-analysis. Biomed Res Int. 2015;2015:729768. doi: 10.1155/2015/729768. Epub 2015 Jan 22.
Sivaramakrishnan A, Madhavan S. Combining transcranial direct current stimulation with aerobic exercise to optimize cortical priming in stroke. Appl Physiol Nutr Metab. 2021 May;46(5):426-435. doi: 10.1139/apnm-2020-0677. Epub 2020 Oct 23.
Gomes-Osman J, Tibbett JA, Poe BP, Field-Fote EC. Priming for Improved Hand Strength in Persons with Chronic Tetraplegia: A Comparison of Priming-Augmented Functional Task Practice, Priming Alone, and Conventional Exercise Training. Front Neurol. 2017 Jan 17;7:242. doi: 10.3389/fneur.2016.00242. eCollection 2016.
Burns AS, Marino RJ, Kalsi-Ryan S, Middleton JW, Tetreault LA, Dettori JR, Mihalovich KE, Fehlings MG. Type and Timing of Rehabilitation Following Acute and Subacute Spinal Cord Injury: A Systematic Review. Global Spine J. 2017 Sep;7(3 Suppl):175S-194S. doi: 10.1177/2192568217703084. Epub 2017 Sep 5.
Mangold S, Keller T, Curt A, Dietz V. Transcutaneous functional electrical stimulation for grasping in subjects with cervical spinal cord injury. Spinal Cord. 2005 Jan;43(1):1-13. doi: 10.1038/sj.sc.3101644.
El Masry WS, Tsubo M, Katoh S, El Miligui YH, Khan A. Validation of the American Spinal Injury Association (ASIA) motor score and the National Acute Spinal Cord Injury Study (NASCIS) motor score. Spine (Phila Pa 1976). 1996 Mar 1;21(5):614-9. doi: 10.1097/00007632-199603010-00015.
Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2006 Mar;44(3):143-51. doi: 10.1038/sj.sc.3101822.
Other Identifiers
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REC/RCR&AHS/22/0214
Identifier Type: -
Identifier Source: org_study_id
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