| CTRI Number |
CTRI/2026/02/104220 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Early versus Delayed range of motion and Weight Bearing after Ankle Fracture Surgery: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Early versus Delayed Mobilization and Weight Bearing after Ankle Fracture Surgery : A Comparative Outcome Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CV Manishchand |
| Designation |
Post Graduate, Department of Orthopaedics |
| Affiliation |
Ganga Medical Centre and Hospitals |
| Address |
Department of Orthopaedic Trauma, A block, Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore - 641 043 , India
Department of Orthopaedic Trauma, A block, Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore - 641 043 , India
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7598116799 |
| Fax |
|
| Email |
unni.nag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Velmurugesan P |
| Designation |
Associate consultant, Department of Orthopaedics |
| Affiliation |
Ganga Medical Centre and Hospitals,Department of Orthopaedics |
| Address |
Department of Orthopaedic Trauma, A block, Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore - 641 043 , India
Department of Orthopaedic Trauma, A block, Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore - 641 043 , India
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9791197520 |
| Fax |
|
| Email |
drvelmurugesan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CV Manishchand |
| Designation |
Post Graduate, Department of Orthopaedics |
| Affiliation |
Ganga Medical Centre and Hospitals,Department of Orthopaedics |
| Address |
Department of Orthopaedic Trauma, A block, Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore - 641 043 , India
Department of Orthopaedic Trauma, A block, Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore - 641 043 , India
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7598116799 |
| Fax |
|
| Email |
unni.nag@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ganga Medical Centre & Hospitals Pvt Ltd |
| Address |
Ganga Medical Centre & Hospitals Pvt Ltd, 313,314 1, Mettupalayam Road, Saibaba Kovil, Coimbatore 641 043 , India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 C V Manish Chand |
Ganga Medical Centre & Hospitals |
Ganga Medical Centre & Hospitals Pvt Ltd,313,314-1, Mettupalayam Road,Saibaba Kovil,Coimbatore - 641 043 , India
Coimbatore
TAMIL NADU |
7598116799
unni.nag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board of Ganga Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S828||Other fractures of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed weight bearing and mobilization after ankle fracture fixation |
In delayed weight bearing group, ankle mobilization and weight bearing started from week 6 post operative |
| Intervention |
Early weight bearing and mobilization after ankle fracture fixation |
In early weight bearing group, ankle mobilization started from day 2 post operative and weight bearing from 2 weeks post operative |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18 to 60 years of age
Closed isolated, bimalleolar, tri-malleolar ankle fracture treated with ORIF |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and greater than 60 years
Poor skin condition
Open fractures
Associated syndesmotic injury and tibial plafond fractures
Uncontrolled diabetic with HbA1C greater than 8
Neuropathic joints
Immunocompromised state
Polytrauma with associated fractures at other site affecting mobilization
Delayed presentation more than 4 weeks
Fixation with compromised stability |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immediate Weight Bearing improves outcomes in terms of early function and cost-effectiveness, with no increase in complications with decrease in patient inconvenience. |
Outcomes will be assessed at 2nd day,2nd week,6th week,3rd month and 6th month post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/03/2026 |
| 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="1"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [unni.nag@gmail.com].
- For how long will this data be available start date provided 01-05-2028 and end date provided 01-05-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims at proving early weight bearing post ankle fracture fixation leads to improved return of ankle range of motion, fracture union rates and early return to work. |