| 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
|
|
|
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
|
|
|
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
|
|
|
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. |