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CTRI Number  CTRI/2025/07/090696 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy]  
Study Design  Cluster Randomized Trial 
Public Title of Study   A study to see how early balance and movement therapy affects walking, balance, and daily activities in patients after brain surgery 
Scientific Title of Study   The Effect Of Early Vestibular Rehabilitation and Balance Training on Functional Balance, Gait and Activities of Daily Living in Patients with Cerebellopontine Angle Tumor Resection 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja More 
Designation  Post Graduate Student in Occupational Therapy 
Affiliation  OT Training School and Centre LTMMC and GH 
Address  5th floor MRO building, Occupational Therapy Training School and Centre, Lokmanya Tilak Municipal Medical College and General Hospital, Laxmibai Kelkar Road, Sion East, Mumbai, Maharashtra, India 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9930334313  
Fax    
Email  pooja2000more@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuradha Pai  
Designation  Asst Professor 
Affiliation  OT Training School and Centre LTMMC and GH 
Address  5th floor MRO building, Occupational Therapy Training School and Centre, Lokmanya Tilak Municipal Medical College and General Hospital, Laxmibai Kelkar Road, Sion East, Mumbai, Maharashtra, India 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9820661856  
Fax    
Email  suchanu@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anuradha Pai  
Designation  Asst Professor 
Affiliation  OT Training School and Centre LTMMC and GH 
Address  5th floor MRO building, Occupational Therapy Training School and Centre, Lokmanya Tilak Municipal Medical College and General Hospital, Laxmibai Kelkar Road, Sion East, Mumbai, Maharashtra, India 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9820661856  
Fax    
Email  suchanu@rediffmail.com  
 
Source of Monetary or Material Support  
Occupational Therapy school and center Lokmanya Tilak Municipal Medical College Sion Mumbai 
 
Primary Sponsor  
Name  Occupational Therapy school and center Lokmanya Tilak Municipal Medical College Sion Mumbai 
Address  Lokmanya Tilak Municipal Medical College Sion Mumbai 400022 
Type of Sponsor  Government 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 Pooja More  Lokmanya Tilak Municipal Medical College and General Hospital  5th floor MRO building, Occupational Therapy Training School and Centre, Lokmanya Tilak Municipal Medical College and General Hospital, Laxmibai Kelkar Road, Sion East, Mumbai, Maharashtra, India 400022
Mumbai
MAHARASHTRA 		 9930334313

pooja2000more@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research, Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D337||Benign neoplasm of other specifiedparts of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Balance Training  Patients in the Balance Training Group will receive balance training for 6 weeks. Inpatient rehab will focus on static sitting and standing balance. Outpatient rehab will progress to dynamic balance and mobility training. 
Intervention  Vestibular and Balance Training  Patients in the Vestibular and Balance training Group will receive 6 weeks. The inpatient phase will include seated cervical and trunk movements with horizontal-vertical eye-head coordination along with static sitting and standing balance . The outpatient phase will focus on dynamic standing tasks, gait stabilization, and advanced cervical and visual-vestibular integration along with dynamic balance and mobility training. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. First surgery involving cerebellopontine angle resection
2. The age range is twenty to sixty years, applicable to both males and females
3. The MOCA score range should be between eighteen and thirty
4. The motion sensitivity test and quotient score should be between eleven percent moderate to one hundred percent severe

 
 
ExclusionCriteria 
Details  Any other neurological or psychiatric illness or autoimmune disease. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Motion sensitivity will be assessed using Motion Sensitivity Scale.
Gait and Balance parameters will be assessed using the Functional Gait Assessment (FGA) Scale.
ADL parameters will be assessed using the Vestibular Activities of Daily Living (VADL) Scale. 		 Motion Sensitivity Scale, Functional Gait Assessment (FGA) Scale. Vestibular Activities of Daily Living (VADL) Scale. All the three scale will be assessed at Day 0 of week 1 , end of the inpatient rehabilitation at end of 2 weeks and at the end of the outpatient rehabilitation at the end of 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/07/2025 
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="1"
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   This study aims to evaluate the effect of early vestibular rehabilitation and balance training on functional balance, gait, and activities of daily living in patients post Cerebellopontine Angle (CPA) tumor resection. A total of 40 patients (aged 20–60 years) will be included, divided equally into a conventional group (balance training only) and an interventional group (balance + vestibular rehabilitation). Inclusion criteria include a MoCA score of 18–30 and Motion Sensitivity Quotient (MSQ) score of 11–100%. Participants will undergo 2 weeks of supervised inpatient therapy (5 days/week) followed by 4 weeks of structured outpatient therapy (once a week). Outcome measures include the Motion Sensitivity Test, Functional Gait Assessment, and the Vestibular Activities of Daily Living (VADL) scale. The conventional group will receive only balance training, focusing on static sitting and standing tasks during inpatient rehab and progressing to dynamic balance, gait training, and obstacle navigation during outpatient sessions. The interventional group will receive both vestibular and balance training. Inpatient vestibular rehab will emphasize seated cervical and trunk movements with horizontal-vertical eye-head coordination. Outpatient vestibular rehab will include dynamic standing tasks, gait stabilization, and visual-vestibular integration exercises. 
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