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

NCT05411692 | Completed

• 1 other identifier: REC/RCR&AHS/22/0214
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• Hand Dynamometer

  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

  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

  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

  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 Outcomes (1)

• Spinal Cord Independence Measure

  6th weeks

Study Arms (3)

Functional electrical stimulations and motor priming exercise

EXPERIMENTAL

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

Functional electrical stimulations

ACTIVE COMPARATOR

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

Convetional phyusical therapy

PLACEBO COMPARATOR

The prescription of resistance load for strength training will be performed with fine motor exercise , based on sub maximal repetitions

Other: Conventional physical therapy

Interventions

Functional electrical stimulations and motor priming exercise OTHER

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 and motor priming exercise

Functional electrical stimulations OTHER

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

Functional electrical stimulations

Conventional physical therapy OTHER

a structured exercise protocol targeting strength (2 days/week) and endurance (3days/week) training

Convetional phyusical therapy

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Lahore general Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (11)

• 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.

  PMID: 30497965 BACKGROUND

• 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.

  PMID: 29789707 BACKGROUND

• 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.

  PMID: 16004574 BACKGROUND

• 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.

  PMID: 28277966 BACKGROUND

• 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.

  PMID: 25685805 BACKGROUND

• 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.

  PMID: 33095999 BACKGROUND

• 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.

  PMID: 28144229 BACKGROUND

• 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.

  PMID: 29164023 BACKGROUND

• 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.

  PMID: 15289804 BACKGROUND

• 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.

  PMID: 8852318 BACKGROUND

• 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.

  PMID: 16130018 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Binash Afzal, PHD*

  Riphah international university lahore campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: March 15, 2022
• Primary Completion: September 20, 2022
• Study Completion: November 15, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)