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CTRI Number  CTRI/2024/03/064523 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To improve Sitting Dynamic Balance in Chronic Spinal Cord Injury using Functional Electrical Stimulation and Therapeutic Exercises 
Scientific Title of Study   The Effect of functional Electrical Stimulation and Therapeutic exercises on sitting dynamic balance in chronic Spinal Cord Injury patient Randomized Controlled Trial.  
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejal Varpe  
Designation  PG student  
Affiliation  Neuro Physiotherapy Department 
Address  Neuro Physiotherapy Department, Dr. APJ Abdul Kalam College Of Physiotherapy, Pravara institute of Medical Sciences, Loni, Ahmednagar, 413736
Neuro Physiotherapy Department, Dr. APJ Abdul Kalam College Of Physiotherapy, Pravara institute of Medical Sciences, Loni, Ahmednagar, 413736
Ahmadnagar
MAHARASHTRA
413763
India 
Phone  9307244287  
Fax    
Email  tejalvarpe12345@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejal Varpe  
Designation  PG student  
Affiliation  Pravara Institute of Medical Sciences Loni 
Address  Neuro Physiotherapy Department, Dr. APJ Abdul Kalam College Of Physiotherapy, Pravara institute of Medical Sciences, Loni, Ahmednagar, 413736
Neuro Physiotherapy Department, Dr. APJ Abdul Kalam College Of Physiotherapy, Pravara institute of Medical Sciences, Loni, Ahmednagar, 413736
Ahmadnagar
MAHARASHTRA
413763
India 
Phone  9307244287  
Fax    
Email  tejalvarpe12345@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shyam Kurapati 
Designation  Professor  
Affiliation  DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institite of Medical Sciences Loni 
Address  DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institite of Medical Sciences Loni
DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institite of Medical Sciences Loni
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8978438484  
Fax    
Email  Kurapatiphysiotherapy2023@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul kalam collage of physiotherapy Pravara institute of medical sciences 
 
Primary Sponsor  
Name  DR. APJ Abdul Kalam Collage of Physiotherapy,pims 
Address  DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institite of Medical Sciences Loni 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejal Varpe  Pravara Institute of medical sciences  Department of Neurophysiotherapy Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 09307244287

tejalvarpe12345@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethical committee of Dr. APJ Abdul Kalam COPT  Approved 
Institutional ethical committee of Dr. APJ Abdul Kalam COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  The Effect of functional Electrical Stimulation and Therapeutic exercises on sitting dynamic balance in chronic Spinal Cord Injury patient Randomized Controlled Trial   Expiremental Group GROUP ‘A’ (Functional electrical stimulation + Therapeutic Exercises) Functional electrical stimulation Duration 5 mins Frequency 3Hz position bed side sitting or prone Therapeutic Exercises 1. Half spinal Rotation 2. Pelvic bridging with shift 3. Pick the objects 4. Punches 5. Sitting on unstable platform (10 reps 2 sets) Each exercise  
Comparator Agent  The Effect of functional Electrical Stimulation and Therapeutic exercises on sitting dynamic balance in chronic Spinal Cord Injury patient Randomized Controlled Trial  GROUP ‘B’ Control Group (Therapeutic exercises 1. Half spinal Rotation 2. Pelvic bridging with shift 3. Pick the objects 4. Punches 5. Sitting on unstable platform (10 reps 2 set) Each exercise 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants included will be:
1. Age 18 to 60 years.
2. Both Male and Female
3. Duration of injury 1year and more
4. Traumatic origin of the injury.
5. Patients hemodynamically stable.
 Level of injury (Thoracic and lumbar T5 to L1)

 
 
ExclusionCriteria 
Details  Participants excluded will be:
1. Unstable medical condition
2. Dependent on mechanical ventilation
3. Metal implants
4. Intolerance of tFES
5. EPILEPSY

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Sitting Balance Scale
2. Trunk Impairment scale
 		 Week 0 and Week 6
 
 
Secondary Outcome  
Outcome  TimePoints 
Nill  Nill 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.5 The 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)


Exclusion 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.






 
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