| 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 |
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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. |
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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 |
|
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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. |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
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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 closedâ€
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.
|
|
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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
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Foot Pressure Analysis using OHM - 3000 |
plantar pressure |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Cadence |
No. of steps per minute |
| Dynamic gait analysis |
dynamic balance examination |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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 .
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