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CTRI Number  CTRI/2022/09/045616 [Registered on: 19/09/2022] Trial Registered Prospectively
Last Modified On: 27/05/2023
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   Effects of Transcutaneous Electrical Nerve Stimulation machine and Functional Electrical Stimulation machine on Spasticity, Mobility and Gait Parameters in Stroke Survivors. 
Scientific Title of Study   Effects of Transcutaneous Electrical Nerve Stimulation and Functional Electrical Stimulation on Spasticity, Mobility and Gait Parameters in Stroke Survivors. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Karambelkar 
Designation  PG student  
Affiliation  Dr. D. Y.Patil college of Physiotherapy Pimpri,Pune. 
Address  Dr.D.Y.Patil college of physiotherapy sant tukaram nagar pimpri pune.411018.
Dr. D.Y. Patil college of physiotherapy Dept. of Neurosciences 3rd floor
Pune
MAHARASHTRA
411018
India 
Phone  9172400102  
Fax    
Email  kaditir@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Gazbare 
Designation  MPT 
Affiliation  Dr. D.Y.Patil College Of Physiotherapy Pimpri,Pune. 
Address  Dr. D.Y.Patil College Of Physiotherapy Sant Tukaram Nagar Pimpri Pune. 411018.
Dr. D.Y. Patil college of physiotherapy Dept. of Neurosciences 3rd floor
Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  preeti.gazbare@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Aditi Karambelkar 
Designation  MPT1 (PG)Student 
Affiliation  Dr. D. Y.Patil college of Physiotherapy Pimpri,Pune. 
Address  Dr.D.Y.Patil college of physiotherapy sant tukaram nagar pimpri pune.411018.
Dept. Of Neurosciences 3rd floor
Pune
MAHARASHTRA
411018
India 
Phone  9172400102  
Fax    
Email  kaditir@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y. Patil college of physiotherapy,pimpri,pune. 
 
Primary Sponsor  
Name  Aditi Karambelkar 
Address  Dr. D.Y.Patil College Of Physiotherapy Sant tukaram nagar Pimpri Pune. 411018 
Type of Sponsor  Other [Student] 
 
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 
Aditi karambelkar  Dr. D. Y. Patil college of physiotherapy,pimpri,pune.  Dr. D. Y. Patil college of physiotherapy Sant tukaram nagar pimpri,pune 411018. Dept. of Neurosciences 3rd floor Room No.1 in right side.
Pune
MAHARASHTRA 		 9172400102

kaditir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FES  For Group B : the protocol will be FES and conventional therapy for 3 consecutive weeks which includes 4 sessions per week.   
Intervention  TENS  25 willing participants will be selected with stroke in each group For Group A : the protocol will be TENS and conventional therapy for 3 consecutive weeks which includes 4 sessions per week.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -Diagnosed case of stroke by physician
-Age between 30- 65 years
-Both males and females
-Subjects who are having spasticity on modified Ashworth scale (Ranges between1,1+ and 2).
-Ambulatory subjects who are able to walk 10 to 12 steps

 
 
ExclusionCriteria 
Details  -Individuals with neurological deficits like Alzheimer’s disease, Parkinson’s disease, vestibular dysfunction, etc.
-Individuals with Musculo skeletal disorders like recent fractures. severe arthritis in lower limbs.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Modified modified Ashworth Scale
2.Time Up and Go Test



 		 Protocol will be for the 4 sessions for 3 consecutive weeks respectively.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Modified Tardieu Scale
2.H reflex
3.Ankle range of motion
 		 Protocol will be for the 4 sessions for 3 consecutive weeks respectively. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/09/2022 
Date of Study Completion (India) 24/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/05/2023 
Estimated Duration of Trial   Years="0"
Months="7"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Title: Effects of transcutaneous electric stimulation and functional electric stimulation on spasticity, mobility and gait parameters in stroke survivors.


Aim:

 To find the effect of Transcutaneous electrical stimulation and Functional electrical stimulation on spasticity mobility and gait parameters in stroke patients.


Objectives: 

To compare the effect of Transcutaneous electrical stimulation and Functional electrical stimulation on spasticity, mobility and gait parameters in stroke patients.


Need Of Study :

Spasticity is often managed using physical therapy interventions, pharmacologic agents, and surgical procedures. The phenomenon of spasticity is known to be because of hyperexcitability of the stretch reflex mediated by Ia afferents due to loss of inhibition from dorsal reticulospinal tract.

TENS has been hypothesized to modulate spasticity by various mechanisms such as modulation of reciprocal inhibition, reducing stretch reflex excitability, and increasing presynaptic inhibition. Evidence from studies on individuals without stroke shows that TENS can reduce corticomotor excitability of the stimulated regions, thus modulating brain plasticity. Based on the different mechanisms stated above, TENS may be applied over the spastic muscle, or its antagonist, or along the course of the nerve, or distal to the spastic muscle such as on acupuncture points. TENS is cost-effective, can be self-administered, and has fewer side effects than other treatments for spasticity. It can be used for managing spasticity at home, making it a promising alternative or adjunct to current standard therapies.

FES activates several muscles electrically in a coordinated and sequenced manner via nerve fibres to produce a particular function. FES has been
applied in varied contexts such as gait training, muscle re-education, and spasticity suppression. Given that both may reduce spasticity, the objective of this study was to compare TENS and FES and measure the duration of after effects on spasticity, mobility and quality of life in stroke patients. Moreover, we incorporated outcomes such as the modified Ashworth scale as assessment tool for spasticity, SS-QOL scale for assessing quality of life, time up and go test for the mobility. Also there are only few studies are present related to this topic in stroke patients.

NULL HYPOTHESIS:
• Effects of Transcutaneous electrical stimulation and functional electrical stimulation is equally effective on spasticity, mobility and gait parameters in stroke patients.
ALTERNATIVE HYPOTHESIS:
•H1: Effect of Transcutaneous electrical stimulation is more effective than functional electrical stimulation on spasticity, mobility and gait parameters in stroke patients.
•H2: Effect of Functional electrical stimulation is more effective than transcutaneous electrical stimulation on spasticity, mobility and gait parameters in stroke patients.


Materials and Methodology : 
-Study design: Experimental                                                            
-Study setting: Dr. D. Y. Patil medical college and hospital.
-Target Population : Stroke Patients                                                                          
Dr. D. Y. college of physiotherapy,pune.
-Sample Population: age 30 and above                                         
-Sampling method: Purposive
-Sample Size : 50 

Introduction :

•  Stroke is the third cause of mortality in the world. Stroke results in movement problems like spasticity, atypical pattern of movement, compensatory strategies which lead to functional limitations and disability. Hemiplegia or hemiparesis i.e., paralysis/weakness of one side of the body is the most common presentation of stroke. The phenomenon of spasticity is known to be because of hyperexcitability of the stretch reflex mediated by Ia afferents due to loss of inhibition from dorsal reticulospinal tract

• TENS has been hypothesized to modulate spasticity by various mechanisms such as modulation of reciprocal inhibition, reducing stretch reflex excitability, and increasing presynaptic inhibition. Evidence from studies on individuals without stroke shows that TENS can reduce corticomotor excitability of the stimulated regions, thus modulating brain plasticity. 

• TENS is cost-effective, can be self-administered, and has fewer side effects than other treatments for spasticity. FES therapy is associated with neuroplasticity post stroke and thus can contribute to neural recovery.

• The Stroke Rehabilitation Evidence-Based Review states there is evidence (i.e., findings supported by a meta-analysis or at least 2 randomized controlled trials) that FES improves upper extremity function, prevents the development of shoulder subluxation, and decreases spasticity and, when combined with gait retraining, can improve gait performance.

Procedure:

    The participants were included as per the inclusion criteria and divided into two groups as Group A and Group B. This study will be conducted for the 3 consecutive weeks and 4 sessions per week in which two groups will be created in which one group will get TENS for 30 mins and conventional therapy and other group will get FES for 30mins and conventional therapy. Each group will get the protocol for 60 mins with modality and conventional therapy. The outcome measures for this study will be the Modified modified Ashworth scale, Modified Tardieu scale, Time up and Go test, H-reflex, Ankle ROM and Dynamic gait index measuring scale.




 
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