| CTRI Number |
CTRI/2026/01/102081 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [agility training] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of balance and quick movement exercises on daily life in people using a below knee artificial leg |
|
Scientific Title of Study
|
Effect of Agility Training on Quality of Life Among Unilateral Transtibial Amputees Using Prosthesis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHAMED AFZAL SARFRAZ H |
| Designation |
student |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT- orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
OT- paediatric division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9600820754 |
| Fax |
|
| Email |
afzalsarfraz001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Buvaneshwari S |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT- paediatric division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MOHAMED AFZAL SARFRAZ H |
| Designation |
student |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT- orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
OT- paediatric division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
TAMIL NADU
603103
India |
| Phone |
9600820754 |
| Fax |
|
| Email |
afzalsarfraz001@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT- orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103 |
|
|
Primary Sponsor
|
| Name |
MOHAMED AFZAL SARFRAZ H |
| Address |
OT- orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr bhuvaneshwari S |
Chettinad General Hospital |
OT- orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
Chennai
TAMIL NADU |
9840016032
bhuvaneshwaris@care.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z895||Acquired absence of leg below knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agility training |
Before enrolling each participant in the study, informed consent will be obtained from their
participant , using consent forms approved by the Institutional Review Board of Chettinad
University Hospital (CHRI, CARE). A total of 30 individuals, aged 18 -50 years and diagnosed
with Unilateral transtibial amputee will be recruited from the Occupational Therapy And
Orthopaedic Department at Chettinad Hospital and Mukti M.S. Dadha Foundation,
meenambakam and Clinics in the Chengalpattu District. After obtaining consent and confirming
inclusion criteria, participants will be randomly assigned into two groups: an intervention group
(n = 15) and a control group (n = 15). Pre-intervention assessment of the independency will be
conducted using the WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF
).The experimental group will receive AGILITY TRAINING, while the Control Group will not receive
any intervention by researcher during this time. Eg: Each session will last 45 minutes,3 days per
week, for 4 weeks. After the 4-weeks intervention period, the independency will be reassessed
using the same tools WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF).
Pre- and post-intervention scores will be statistically analysed to evaluate the effectiveness of
the intervention. WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF )
SCALE
|
| Comparator Agent |
WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF |
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral transtibial below knee amputees. First time prosthesis users.
Sound limb muscle strength grade more than 3 Manual Muscle Testing. Ability to stand
unsupported for at least 15 minutes. Ability to walk a minimum of 15 steps using the prosthesis.
Age range: 18 to 50 years. Able to understand and follow commands. Those who has low balance
confidence |
|
| ExclusionCriteria |
| Details |
Presence of psychiatric conditions. Sensory or motor
impairments due to neurological disorders. Perceptual disorders (e.g., visuospatial or
cognitive–perceptual deficits). Any other medical instability that could interfere with training |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF WHOQOL-BREF
) |
Quality of life will be assessed using WHOQOL-BREF at baseline (pre-intervention), and reassessed after completion of four weeks of Agility training (post-intervention)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="0"
Months="6"
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 is a randomized , parallel group , active controlled trial evaluating the A total of 30 individuals, aged 18 -50 years and diagnosed with Unilateral transtibial amputee will be recruited from the Occupational Therapy And Orthopaedic Department at Chettinad Hospital and Mukti M.S. Dadha Foundation, meenambakam and Clinics in the Chengalpattu District. After obtaining consent and confirming inclusion criteria, participants will be randomly assigned into two groups: an intervention group (n = 15) and a control group (n = 15). Pre-intervention assessment of the independency will be conducted using the WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF ).The experimental group will receive AGILITY TRAINING, while the Control Group will not receive any intervention by researcher during this time. Eg: Each session will last 45 minutes,3 days per week, for 4 weeks. After the 4-weeks intervention period, the independency will be reassessed using the same tools WORLD HEALTH ORGANIZATION QUALITY OF LIFE – BREF (WHOQOL-BREF). Pre- and post-intervention scores will be statistically analysed to evaluate the effectiveness of the intervention. |