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CTRI Number  CTRI/2024/10/074996 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of backward walking with rhythmic auditory stimulation on balance of post-stroke patients 
Scientific Title of Study   Effect of backward walking with rhythmic auditory stimulation on balance of post-stroke patients-a randomized controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NIHADA N 
Designation  Post graduate resident 
Affiliation  yenepoya physiotherapy college 
Address  Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8075187384  
Fax    
Email  nihaanazz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lourdhraj I 
Designation  professor 
Affiliation  yenepoya physiotherapy college 
Address  Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9940529169  
Fax    
Email  lourdhuraj@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  Lourdhraj I 
Designation  professor 
Affiliation  yenepoya physiotherapy college 
Address  Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9940529169  
Fax    
Email  lourdhuraj@yenepoya.edu.in  
 
Source of Monetary or Material Support  
yenepoya physiotherapy college,Naringana,manglure,karnataka,575018 
 
Primary Sponsor  
Name  NIHADA N 
Address  Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka 
Type of Sponsor  Other [self] 
 
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 Lourdhuraj I   Yenepoya Ayurveda Medical College Hospital(Physiotherapy Department),4th floor  Yenepoya Ayurveda Medical College Hospital (physiotherapy department,4th floor) Naringana, Manglure, Karnataka PIN:575018
Dakshina Kannada
KARNATAKA 		 9940529169

lourdhuraj@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balance training  backward training with rhythmic auditory stimulation in a straight line (4 weeks)5 times per week 
Comparator Agent  trunk control exercise and strengthening exercise  upper and lower limb strengthening by use of weight cuffs or dumbbells (4 weeks) 5 times per week  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Individual with confirmed history of stroke (between 6 months to 12 months)
Independent walk over 10 m was possible with or without assistive device
No visual and auditory deficit
 
 
ExclusionCriteria 
Details  • Individual who had difficulty in BW
• Any other neurological deficit

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
dynamic gait index
five time sit to stand test 		 both outcome measures will be taking during the baseline and after 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   21/10/2024 
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="1"
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
Modification(s)  
Study Summary:
Title: Effect of Backward Walking with Rhythmic Auditory Stimulation on Balance of Post-Stroke Patients: A Randomized Controlled Triall
Objective:
The study aimed to evaluate the effect of backward walking combined with rhythmic auditory stimulation (RAS) on improving balance in post-stroke patients.
Methods:  
- Design: Randomized controlled trial
- Participants: Post-stroke patients with impaired balance. Subjects were randomly assigned to two groups: an experimental group and a control group.
- Intervention: The experimental group performed backward walking combined with rhythmic auditory stimulation + conventional exercise , while the control group performed only the conventional exercise.
- Duration: Typically, the intervention lasted for 4 weeks, with regular sessions (e.g., 3-5 times per week).
- Outcome Measures: Balance was assessed using Dynamic Gait Index (DGI)&Five times sit to stand test, before and after the intervention.
Here  I am  trying  to find that Backward walking combined with rhythmic auditory stimulation can be an effective intervention to improve balance in post-stroke patients. This method may stimulate both motor and auditory pathways, enhancing neuroplasticity and aiding in recovery of balance.
 
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