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CTRI Number  CTRI/2025/07/090011 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   How Foot and Ankle Therapy Affects Balance in Older Adults 
Scientific Title of Study   EFFECT OF ANKLE AND FOOT MOBILIZATION ON STATIC BALANCE IN OLDER ADULTS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Nagpal 
Designation  PG student  
Affiliation  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala 
Address  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital
Ambala
HARYANA
133207
India 
Phone  9817030017  
Fax    
Email  aditingpl2731@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manu Goyal  
Designation  Professor MMDU  
Affiliation  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala 
Address  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital
Ambala
HARYANA
133207
India 
Phone  8307715320  
Fax    
Email  manu.goyal@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  Dr Manu Goyal  
Designation  Professor MMDU  
Affiliation  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala 
Address  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital
Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital

HARYANA
133207
India 
Phone  8307715320  
Fax    
Email  manu.goyal@mmumullana.org  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aditi Nagpal 
Address  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala pincode 133207, haryana , india 
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 
Dr Aditi Nagpal  mm super speciality hospital mullana ambala haryana india  Maharishi Markandeshwar(Deemed to be university) Mullana Ambala ss opd 1st floor room no 112 super speciality hospital
Ambala
HARYANA 
09817030017

aditingpl2731@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE Communication of decision of the Ethics committee IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  older adults with no lower limb injury 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ankle and foot grade 3 maitland mobilization  Grade III Maitland accessory mobilization, 3 sets of 30 repetitions with 60 sec intervals bilaterally will be performed. single sesion only  
Comparator Agent  neuromuscular training  trampoline propioception training tandem stance 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Age 60 to 75 years

2 Both males and females
 
 
ExclusionCriteria 
Details  Chronic Ankle instability
History of ankle and foot fracture in the last six month
Previous history of stroke in the last six month
Any other neurological disorder
Previous history of any eye surgery in the last six months
Vestibular disorder
Arthritis of the lower extremity
Any other musculoskeletal disorder of lower limb
Metabolic disorder like- Diabetes mellitus, High blood pressure
 
 
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 
4 stage balance test
 
4 stage balance test
baseline and immediate after session
 
 
Secondary Outcome  
Outcome  TimePoints 
BESS Balance Error Scoring System  baseline & immediate after intervention 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/07/2025 
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  

overall balance begins to decline in a progressive way from midlife starting at about age fifty sensory motor and integrative system participate and interact in postural control any deterioration in these systems or in the underlying mechanism of  balance will effect this complex ability falls are the major threats to older adults quality of life often causes decline in self care ability and participation in physical and social activities fear of falling develops in twenty to thirty nine who fall can lead to further limiting activity independent of injury the foot and ankle are of  especial importance since they constitute the base of support of the body and transmit the loads to the ground However common age related alterations such as loss of strength and limited range of motion  due to loss of quality of the musculature of the joint complex has a negative impact on balance by altering gait patterns and increasing the risk of fall among other consequences in the case of the ankle arthrokinematics manual therapy based on the joint mobilization techniques has proven to be useful tool to recover the normal range of movement and balance still there are lack of evidence which says about static balance to determine the efficacy of ankle and foot mobilization on static balance in older adults 

 Single blinded Two group pre and post experimental design Patients will be recruited based on inclusion and exclusion criteria There will be pre and post balance assessment of each individual four stage balance test and BESS will be used to assess the static balance of an individual Grade Three Maitland mobilization of ankle and foot for will be given bilaterally The collected data will be analyzed by using SPSS twenty version Normality analysis will be done with the help of Shapiro Wilk Kolmogorov Smirnov test Descriptive statistics will be expressed as either Mean  Standard Deviation or Median IQR

 
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