FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072856 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
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 compare the effects of Rhythmic auditory stimulation versus vestibular rehabilitation therapy on balance and walking speed in patients having Paralysis. 
Scientific Title of Study   Effectiveness Of Rhythmic Auditory Stimulation versus Vestibular Rehabilitation Therapy on Balance and Walking speed among patient having chronic stroke : A Comparative Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Minal Soni  
Designation  MPT Scholar  
Affiliation  Parul Institute Of Physiotherapy 
Address  2ND Floor, Neuro Physiotherapy OPD, Parul Sevaashram Hospital, Parul University, Post Limda, Wagodia, Gujrat

Vadodara
GUJARAT
391760
India 
Phone  7977936791  
Fax    
Email  minalsoni0507@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Joyal Tejpal 
Designation  Assistant Professor  
Affiliation  PARUL INSTITUTE OF PHYSIOTHERAPY 
Address  2ND FLOOR, NEURO PHYSIOTHERAPY OPD, PARUL SEVAASHRAM HOSPITAL, PARUL UNIVERSITY, POST LIMDA, WAGODIA, GUJRAT

Vadodara
GUJARAT
391760
India 
Phone  7977936791  
Fax    
Email  joyal.tejpal25384@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Minal Soni  
Designation  MPT Scholar  
Affiliation  PARUL INSTITUTE OF PHYSIOTHERAPY 
Address  2ND Floor, Neuro Physiotherapy OPD, Parul Sevaashram Hospital, Parul University, Post Limda, Wagodia, Gujrat

Vadodara
GUJARAT
391760
India 
Phone  7977936791  
Fax    
Email  minalsoni0507@gmail.com  
 
Source of Monetary or Material Support  
Minal Soni 404, Shakuntala Bhawan, Opposite Faculty of Performing Arts, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara – 391760, Gujarat State, India. 
 
Primary Sponsor  
Name  Minal Soni 
Address  2ND Floor, Neuro Physiotherapy OPD, Parul Sevaashram Hospital, Parul University, Post Limda, Wagodia, Gujrat  
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 
MINAL SONI   PARUL SEVAASHRAM HOSPITAL   2ND FLOOR, NEURO PHYSIOTHERAPY OPD, PARUL SEVAASHRAM HOSPITAL, PARUL UNIVERSITY, POST LIMDA, WAGODIA, GUJRAT
Vadodara
GUJARAT 
7977936791

minalsoni8919@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul University Institutional Ethics Committee For Human Research (PU-IECHR))  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EXERCISE THERAPY RHYTHMIC AUDITORY STIMULATION   RHYTHMIC AUDITORY STIMULATION : WEEK 1 : •Tapping with one foot while sitting. •Stepping with alternating leg forward/backward. •Tapping with one leg on step platform or on a step & back. •Placing one leg with weight shift on step platform. WEEK 2 : •Sit to stand along with beats. •Stepping over the hurdle with beats. •Alternate Single leg standing •Reach outs in sitting WEEK 3 : •Walking on the spot (marching) with metronome •Walking with metronome •Walking along the barriers (cones) in various patterns, with metronome beats •Step up and step down on a stair along with beats • Sit on edge of chair/ bed and stand up and sit down with eye moments (right and left) •Sit on edge of chair/ bed and stand up and sit down with head moments •Sit on edge of chair/ bed and stand up and sit down, head moments with “eyes closed” WEEK 4 : •Tandem Walking along with beats •Walking and stopping along with on and off beats. •Walking in zig-zag pattern 
Comparator Agent  VESTIBULAR REHABILITATION   WEEK 1 : •Vestibulo-ocular exercise in sitting and instructing patient to stare “a stationery object” with head movements ( horizontal and vertical ) •Vestibulo-ocular exercise in sitting and instructing patient to stare “a moving object” with head stationery WEEK 2 : •Shifting weight in forward and backward direction with neck rotations. •Shifting weight in side to side direction with neck rotations. •Standing on padded mat with fast eye moments(right and left) with feets together. •Standing on padded mat, move their head (right and left) with feets together. WEEK 3 : •Sit on edge of chair/ bed and stand up and sit down with eye moments (right and left) •Sit on edge of chair/ bed and stand up and sit down with head moments •Sit on edge of chair/ bed and stand up and sit down, head moments with “eyes closed WEEK 4 : •Single leg stand with head rotations. •Walking at different speed •Walking forward and backward •Walking in circular path. •Walking with head moments in horizontal and vertical positions •Walking and talking with therapist.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with chronic stroke
2. Involving all the 3 cortical vascular territories.
3. Age group : 40 to 60 years
4. Voluntary control grades more than 3
5. Balance and gait affected
6. No visual perception disorders
8. No auditory perception disorders
9. No hearing impairment
10. Able to understand command
11. Willing to sign the consent form
 
 
ExclusionCriteria 
Details  1. Internal ear infection
2. Any unhealed ulcers and painful wounds in lower limb which may affect balance and speed
3. Presence of any lower limb deformities like FFD (Fixed Flexion Deformity)
4. Any sensory impairment present.
5. Any recent lower limb fracture or surgery
6. Patient having delirium, confusion or other severe consciousness problem.
7. No disease other than stroke that influence Lower limb moments
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Foot Pressure Analysis using OHM - 3000  plantar pressure  
 
Secondary Outcome  
Outcome  TimePoints 
Cadence   No. of steps per minute  
Dynamic gait analysis   dynamic balance examination  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/09/2024 
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="0"
Months="6"
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  

•       About 50% of stroke survivors have impaired lower limb functions in subacute and chronic phase, which strongly has impact on ambulation and carrying out Activities of Daily living.  RAS is a form of gait training that involves sensory cuing of motor system; hence it is more required to be part of gait training protocol. Although there are many studies on balance and gait training, RAS was barely given attention and what effects it may have on gait parameters are less focused.

The manner in which gait is adjusted to Acoustic stimuli has received limited attention though its understanding may lead to more effective application of auditory cues in rehabilitation protocol

•      Vestibular Rehabilitation Therapy (VRT) improves one’s compensatory mechanism required for maintaining balance.

VRT is exercise based therapy that aims to promote gaze stability, improve postural stability and facilitate sensory integration.

Although, various studies are being done on proprioception and visual system, less attention is given to vestibular system.

The mechanism in which vestibular system may contribute to balance is given less attention, though it can be easily implemented in balance training protocols.

•       Many studies have been done on  balance training and gait among patients having Therefore, the need arises to perform a study to compare and evaluate which intervention (RAS or VRT) can be more effective and beneficial for patient with Chronic stroke for early recovery.

•       To see the effect of Early recovery with  RAS and vestibular rehabilitation among patients having stroke so we can imply clinically on the patients  and early recovery can be done either choosing any one or combination of both of this protocol .


 
Close