| CTRI Number |
CTRI/2022/10/046797 [Registered on: 26/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| 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
|
Effect of early weight bearing program on knee joint function in patients with tibial plateau fractures- A 3 month follow-up study. |
|
Scientific Title of Study
|
Effect of early weight bearing program with conventional physiotherapy
on functional outcomes in surgically treated proximal tibia fracture-A Pilot
Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anagha Kadam |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8788287434 |
| Fax |
|
| Email |
kadamanagha64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Wani |
| Designation |
Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9960473324 |
| Fax |
|
| Email |
wanisuren@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anagha Kadam |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8788287434 |
| Fax |
|
| Email |
kadamanagha64@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
MGM Institute of physiotherapy |
| Address |
N6 Cidco Aurangabad 431003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anagha Kadam |
MGM Medical College and Hospital |
Orthopedic Ward, 4th floor, N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA |
8788287434
kadamanagha64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S821||Fracture of upper end of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm I ( Early weight bearing plus Conventional Physiotherapy). |
This arm will be given early weight bearing (Toe touch) from Day 3 along with conventional physiotherapy. |
| Comparator Agent |
Arm II ( Restricted weight bearing plus Conventional Physiotherapy). |
This group will not be given any weight bearing but just conventional physiotherapy from Day 3. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with proximal tibial fractures that are managed with open reduction and internal fixation (ORIF).
2. Patients with Type 1,2,3 tibial plateau fractures (Schatzker classification).
3. Operated cases with stable condition and recommended for physiotherapy by the operating surgeon on Day 3
|
|
| ExclusionCriteria |
| Details |
1. Patients having associated Neuro-vascular injury.
2. Patients having associated fractures of upper limb or multiple lower limb
3. Pathological fractures secondary to malignancy or infection.
4. History of Osteoporosis / post-menopausal women
5. History of patients with neurological symptoms.
6. BMI more than 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Range of motion
3. Functional |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quadriceps isometric muscle strength.
2. Adherence.
3. X-ray. |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Planned for Publication |
|
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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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 [kadamanagha64@gmail.com].
- For how long will this data be available start date provided 23-12-2023 and end date provided 23-11-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Objective: 1.To compare the effect of early weight bearing in addition to
conventional post-operative rehabilitation versus restricted
weight bearing along with conventional physiotherapy on pain,
range of motion, quadriceps isometric muscle strength & patient
relevant outcomes in patients with post-operative tibial plateau
fractures at various intervals i.e. at discharge, after 6 weeks and
12 weeks after the surgery. 2. To investigate the effect of early weight bearing on functional
outcomes of pain, range of motion, quadriceps isometric muscle
strength and patient relevant outcomes in patients with postoperative tibial plateau fractures at various intervals i.e. at
discharge, after six weeks and 12 weeks compared to baseline. 3. To investigate the effect of restricted weight bearing on functional
outcomes of pain, range of motion, quadriceps isometric muscle
strength and patient relevant outcomes in patients with postoperative tibial plateau fractures at various intervals i.e. at
discharge, after six weeks and 12 weeks compared to baseline. 4. To observe the adverse effects, (fixation failure, loss of reduction
or joint depression, non- union) of early weight bearing on patients with postoperatively managed tibial plateau fracture.
Design: A Pilot Randomized Controlled Trial
Study Setting: Tertiary Care Hospital
Procedure: Patients with Post-operative Day 3 of tibial plateau fractures above the age
of 18 years will be taken. Eligible patients will be included for the study.
Patients will be divided in two groups Group I Weight bearing and Group
II Restricted weight-bearing group. Before collection of the data Informed
written and verbal consent will be taken from all the patients. Assessment of Knee joint including pain intensity by NPRS
and Range of Motion using universal goniometer, quadriceps isometric
muscle strength by push-pull dynamometer, Knee Injury and Osteoarthritis
Outcome Score (KOOS), post-operative X-ray will be checked on post-operative Day-3 and will be reassessed at discharge , after 6 weeks and after 12 weeks. Adherence will be checked after 6 weeks and 12 weeks by Exercise Adherence Rating Scale (EARS). Group I will be given Early weight bearing along with conventional physiotherapy whereas Group II will be given restricted weight bearing along with conventional physiotherapy.
Early weight bearing Protocol: Day 3 – Till Discharge:
Patient will be made to walk for 10m in a hallway. Partial weight
bearing will be given with touchdown weight bearing (as tolerated
by the patient) and will be increased by 25% approximately as
tolerated by the patient with the use of assistive aid. Discharge - 6 weeks:
Patient will be asked to continue the weight bearing as tolerated
and progress to partial weight bearing (50%) as tolerated with the
use of assistive aid. 6 weeks – 12 weeks:
Patient will be asked to progress from partial weight bearing as
tolerated to partial weight bearing up to 75% with the use of
assistive aid.
Conventional Physiotherapy Protocol: These will include bedside exercises consisting of improving range of motion, increasing strength with progression to balance training.
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