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CTRI Number  CTRI/2026/01/100113 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of a leg exercise program on walking, balance, fall Risk, and confidence in elderly people who are afraid of movement 
Scientific Title of Study   Effectiveness of the knee neuromuscular exercise program on gait, postural sway, balance and fall risk among geriatric subjects with kinesiophobia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  P.C.Suresh 
Designation  Professor 
Affiliation  R.V.S College of physiotherapy 
Address  R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. India
R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. India
Coimbatore
TAMIL NADU
641402
India 
Phone  9894578588  
Fax    
Email  surpt07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  P.C.Suresh 
Designation  Professor 
Affiliation  R.V.S College of physiotherapy 
Address  R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. India.
R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. India.
Coimbatore
TAMIL NADU
641402
India 
Phone  9894578588  
Fax    
Email  surpt07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  P.C.Suresh 
Designation  Professor 
Affiliation  R.V.S College of physiotherapy 
Address  R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. India.
R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. India.
Coimbatore
TAMIL NADU
641402
India 
Phone  9894578588  
Fax    
Email  surpt07@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  P C Suresh 
Address  R.V.S College of physiotherapy, Room No 111, Department of orthopedics, 242B, Trichy Road, Sulur, Coimbatore. Tamil Nadu. Pin code 641402.India. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Franklin Shaju  KMCH Hospital  Out Patient Department Room No A003, Department of orthopedics, Trichy road, Sulur, Coimbatore, Tamilnadu 641402 India
Coimbatore
TAMIL NADU 
9843671222

franklin25in@gmail.com 
Dr Franklin Shaju  R.V.S College of Physiotherapy  Out Patient Department Room No 111, Department of orthopedics, 242-B, Trichy Road, Sulur, Coimbatore. TamilNadu 641402.India.
Coimbatore
TAMIL NADU 
9843671222

franklin25in@gmail.com 
Dr Krishna Kumar  Sri Lakshmi Medical Center and Hospital  Out Patient Department, Room no 11, Department of physiotherapy, Mettupalayam road, Thudiyalur, Coimbatore, Tamil Nadu 641034 India
Coimbatore
TAMIL NADU 
8925900892

smchbpt2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F402||Specific (isolated) phobias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neuromuscular exercise program  Neuromuscular exercise program Quadriceps and hamstring muscle Strengthening exercises Quadriceps and Hamstring stretches Calf stretches 3 sessions per week for 8 week 
Comparator Agent  Strengthening exercises  Quadriceps and hamstring muscle Strengthening exercises Quadriceps and Hamstring stretches Calf stretches 3 sessions for week 8 week  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  74.00 Year(s)
Gender  Both 
Details  Age 60to74 years
Mild to moderate kinesiophobia Tampa Scale of Kinesiophobia score more than 37
Able to walk independently
Both Gender
Able to understand simple verbal communication 
 
ExclusionCriteria 
Details  Poor cognitive impairment
Neurological or orthopedic conditions limiting mobility
History of recent lower limb surgery or fracture within the past 6 months
Unstable cardiovascular conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gait, Postural sway, Balance , Fall risk  At baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Kinesophobia  At baseline, 8 weeks 
 
Target Sample Size   Total Sample Size="148"
Sample Size from India="148" 
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)   04/02/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Population ageing is a rapidly growing global phenomenon, with the number of people aged 60 years and above expected to reach 2.1 billion by 2050, most of them living in low- and middle-income countries. India is experiencing a significant rise in its elderly population, largely in rural areas and among lower socioeconomic groups, leading to increased health and social challenges. Age-related declines in balance, gait, muscle strength, and physical activity, combined with high levels of inactivity and frailty, substantially increase fall risk among older adults. Falls are a major cause of injury, loss of independence, and mortality in the geriatric population. Psychological factors such as kinesiophobia (fear of movement) further worsen physical decline by promoting inactivity. Neuromuscular impairments, particularly at the knee joint, play a key role in gait instability and balance deficits. Although neuromuscular exercise programs have shown benefits in improving physical function, their effectiveness in geriatric individuals with kinesiophobia remains underexplored. This study aims to evaluate the effectiveness of an 8-week knee neuromuscular exercise program on gait, postural sway, balance, fall risk, and levels of kinesiophobia in elderly individuals. The research seeks to provide a comprehensive approach to fall prevention by addressing both physical and psychological factors affecting the geriatric population.

 
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