The Effect of functional Electrical Stimulation and Therapeutic exercises on sitting dynamic balance in chronic Spinal Cord Injury patient Randomized Controlled Trial.

Spinal cord injury (SCI) is the injury of the spinal cord from the foramen magnum to the cauda equina which occurs as a result of compulsion, incision or contusion. The most common causes of SCI in the world are traffic accidents, gunshot injuries, knife injuries, falls and sports injuries 1. More than 90% of SCI cases are traumatic and caused by incidences such as traffic accidents, violence, sports, or falls. The Male-to-female ratio of 2:1 for SCI, which happens more frequently in adults compared to children**.2**

Demographically, men are mostly affected during their early and late adulthood (3rd and 8th decades of life) while women are at higher risk during their adolescence (15–19 years) and 7th decade of their lives. There is a strong relationship between functional status and whether the injury is complete or not complete, as well as level of the injury.2 Among individuals with incomplete spinal cord injury (iSCI), about 75% will experience at least one fall each year, usually while walking. Falls can lead to serious injuries and hospital admissions.

Impaired balance control likely contributes to the high fall rate; consequently, improving balance should be a goal of SCI rehabilitation 3. Functional impairment of primary muscles responsible for posture control in people with SCI leads to diminished control over sitting balance. Sensory–motor integration with normal postural synergies of the lower trunk is also found to be affected.4

In FES, the electrode typically acts as a conductor, delivering electrical charge from a power supply to the tissue. Charge transfer occurs when voltage applied between the active electrode and a second electrode (called the reference electrode) generates an electric field, which in turn, forces electrical charge to flow.5The significance of FES for improving sitting balance with transcutaneous electrodes in individuals with Stroke and SCI has been seen in previous literature. FES can deliver short electric pulses between the electrodes applied over the skin on the muscle nerve, which induces muscle contraction. FES application provides continuous co-activation of muscles in the trunk and is said to improve static balance by correcting the spinal alignment as well as dynamic balance during forward-reaching activities in individuals with SCI**.6**

Maintaining sitting balance can be challenging after a spinal cord injury but practicing targeted core exercises can alleviate some of the fatigue and improve your sitting endurance. Sitting balance is the ability to sit upright and a skill learned early in life. After a cervical or thoracic spinal cord injury, maintaining sitting balance becomes difficult due to weakened and/or lost control over the core muscles.7

Combining functional electrical stimulation (FES) with therapeutic exercises for chronic spinal cord injury can potentially improve dynamic balance. FES can enhance muscle activation, aiding in exercises that target balance and coordination. Consultation with a healthcare professional or physiotherapist is advisable to determine the most effective and safe approach based on individual needs and capabilities8

NEED FOR THE STUDY

·       Studying the effects of functional electrical stimulation (FES) and therapeutic exercise on dynamic sitting balance in Chronic Spinal Cord Injury (SCI) patients is crucial for several reasons.

·     This research could significantly contribute to the knowledge base of rehabilitation strategies for individuals in the chronic phase of SCI. FES and therapeutic exercise target different aspects of neuromuscular function.

·      Studying their combined effects may reveal synergies that could enhance the effectiveness of rehabilitation protocols. study on the effects of FES and therapeutic exercise on dynamic sitting balance in chronic

·       SCI patients is essential for advancing rehabilitation practices, optimizing interventions, and ultimately improving the functional outcomes and quality of life for individuals in the early stages of spinal cord injury.

·       Hence, need for this study is  to find out the effect of functional electrical stimulation and therapeutic exercise on dynamic sitting balance in chronic SCI patients.

RESEARCH QUESTION

Will there be any effect of functional electrical stimulation and therapeutic exercise on dynamic sitting balance in acute SCI patients?

AIM AND OBJECTIVES

 Aim:

To find the effect of functional electrical stimulation and therapeutic exercise on dynamic sitting balance in acute SCI patients.

Objectives:

1.To evaluate the effect of functional electrical stimulation on dynamic sitting balance in acute SCI patients.

2.To evaluate the effect of therapeutic exercise on dynamic sitting balance in acute SCI patients.

Hypotheses

Null Hypothesis (H0):

There will not be significant effect of functional electrical stimulation and therapeutic exercise on dynamic sitting balance in acute SCI patients.

Alternative Hypothesis (H1):

There will be significant effect of functional electrical stimulation and therapeutic exercise on dynamic sitting balance in acute SCI patients.

METHODOLOGY

7.1 Source of Data: Pravara Rural Hospital, Loni.

Study Setting: The study will be conducted at department of Neuro-Physiotherapy,  Dr. A.P.J. Abdul Kalam College of Physiotherapy, PIMS, Loni

7.2 Method of collection of data: Data will be collected by primary investigator

Type of Data:  Quantitative

**Study Design:**Randomized Controlled Trial

Sample size:  30

Participants:  Patients with spinal cord injury

Sampling Method: Simple Random Sampling

**Study Duration:**2 years

Material to be used:

Ø  Data Record Sheet

Ø  Assessment sheet

Ø  Consent Form

Ø  Pen

Ø  Electrical Muscle Stimulation

  OUTCOME MEASURES

Ø  Sitting Balance Scale

Ø  Trunk Impairment scale

SELECTION CRITERIA:

Inclusion criteria:

Participants included will be:

Ø  Age 18 to 60 years.

Ø  Both Male and Female

Ø  Duration of injury 1year and more

Ø  Traumatic origin of the injury.

Ø  Patients hemodynamically stable.

Ø  Level of injury (Thoracic and lumbar T5 to  L1)

E****xclusion criteria:

Participants excluded will be:

Ø  Unstable medical condition

Ø  Dependent on mechanical ventilation

Ø  Metal implants

Ø  Intolerance of tFES

Ø  EPILEPSY

PROCEDURE

·       Protocol will be prepared and ethical clearance will be obtained from the IEC.

·       The Participants will be selected based on the inclusion and exclusion criteria for eligibility.

·       Informed consent will be obtained from the participants and demographic data is recorded.

·       30 Participants will be randomly allocated to 2 groups that is experimental group(n=15) and control group(n=15). Prior assessment of the participants will be done.

·       Experimental group will be administered with Electrical muscle stimulation combined with therapeutic exercises for spinal cord injury patients and control group will be administered with Therapeutic exercises program for spinal cord injury patients.

·       All the instructions will be given verbally, provided demonstration to the participants.

·       The participants will be given exercise regimen and administered to perform one session per day for 4 days in a week for 6 weeks.

·       The variables like Sitting balance scale, Trunk impairment scale will be measured accordingly.

·       Statistical analysis will be done and the results with the conclusion will be mentioned.

REFFERENCES:

1.     Nas K, Yazmalar L, Åžah V, Aydın A, ÖneÅŸ K. Rehabilitation of spinal cord injuries. World J Orthop. 2015 Jan 18;6(1):8-16. doi: 10.5312/wjo.v6.i1.8. PMID: 25621206; PMCID: PMC4303793.

2.     Alizadeh A, Dyck SM, Karimi-Abdolrezaee S. Traumatic Spinal Cord Injury: An Overview of Pathophysiology, Models and Acute Injury Mechanisms. Front Neurol. 2019 Mar 22;10:282. doi: 10.3389/fneur.2019.00282. PMID: 30967837; PMCID: PMC6439316.

3.     Unger J, Chan K, Scovil CY, Craven BC, Mansfield A, Masani K, Musselman KE. Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial. Phys Ther. 2019 Apr 1;99(4):420-427. doi: 10.1093/ptj/pzy153. PMID: 30576475; PMCID: PMC6438350.

4.     Goel T, Sharma N, Gehlot A, Srivastav AK. Effectiveness of immersive virtual reality training to improve sitting balance control among individuals with acute and sub-acute paraplegia: A randomized clinical trial. J Spinal Cord Med. 2023 Nov;46(6):964-974. doi: 10.1080/10790268.2021.2012053. Epub 2021 Dec 22. PMID: 34935603; PMCID: PMC10653758.

5.     Ho CH, Triolo RJ, Elias AL, Kilgore KL, DiMarco AF, Bogie K, Vette AH, Audu ML, Kobetic R, Chang SR, Chan KM, Dukelow S, Bourbeau DJ, Brose SW, Gustafson KJ, Kiss ZH, Mushahwar VK. Functional electrical stimulation and spinal cord injury. Phys Med Rehabil Clin N Am. 2014 Aug;25(3):631-54, ix. doi: 10.1016/j.pmr.2014.05.001. PMID: 25064792; PMCID: PMC4519233.

Bergmann M, Zahharova A, Reinvee M, Asser T, Gapeyeva H, Vahtrik D. The Effect of Functional Electrical Stimulation and Therapeutic Exercises on Trunk Muscle Tone and Dynamic Sitting Balance in Persons with Chronic Spinal Cord Injury: A Crossover Trial. Medicina (Kaunas). 2019 Sep 1.     21;55(10):619. doi: 10.3390/medicina55100619. PMID: 31546613; PMCID: PMC6843124.

1.     Tse CM, Chisholm AE, Lam T, Eng JJ; SCIRE Research Team. A systematic review of the effectiveness of task-specific rehabilitation interventions for improving independent sitting and standing function in spinal cord injury. J Spinal Cord Med. 2018 May;41(3):254-266. doi: 10.1080/10790268.2017.1350340. Epub 2017 Jul 24. PMID: 28738740; PMCID: PMC6055957.

2.     Bergmann M, Zahharova A, Ereline J, Asser T, Gapeyeva H, Vahtrik D. Single session exercises and concurrent functional electrical stimulation are more effective on muscles’ force generation than only exercises in spinal cord injured persons: a feasibility study. J Musculoskelet Neuronal Interact. 2020 Dec 1;20(4):472-479. PMID: 33265074; PMCID: PMC7716694.