EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES

NCT ID: NCT07251699

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-11-01

Brief Summary

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This study will answer the following research questions:

Are there any significant differences between combination of early active knee ROM exercises and weight bearing versus early passive ROM with delayed weight bearing on pain intensity, ROM knee flexion and extension, function, and radiological healing in treatment of patients with TPFs fixed with plates and screws?

Detailed Description

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This study will be conducted to compare the effects of combining early active knee ROM exercises and weight bearing versus early passive ROM and delayed weight bearing on pain intensity, ROM knee flexion and extension, function, and radiological healing in treatment of patients with TPFs fixed with plates and screws.

Tibial plateau fractures are associated with unfavorable outcomes due to a variety of factors, including soft tissue envelopes and cartilage damage, comorbidities such as compartment syndrome, postoperative infection, stiffness or malfunction of the knee, and even post-traumatic osteoarthritis (Narang et al., 2021). Consequently, they not only present surgical challenges but also have serious negative effects on function and quality of life (Arnold et al., 2017; Bhamra and Naqvi, 2021).

Physical therapy including active exercises is well supported in literature but in the late phases of rehabilitation. The concept of introducing early active exercises to patients undergoing rehabilitation following TPFs repaired with implants isn't well-supported in the literature. There aren't any comprehensive studies that specifically examine the application of early active exercises for TPFs repaired with plates and screws (Phansopkar et al., 2022).

There are few studies in form of case reports that applied early active exercises for patients with TPFs. It was found that appropriate surgical intervention followed with planned exercise protocol focussing on long term benefits can greatly help patients with TPFs to achieve early pain free mobility in lower limbs (Narang et al., 2021; Arya and Harjpal, 2023; Bhure et al., 2022).

this study will assess the long term effects of the treatment program for patients with TPFs fixed with plates and screws. So this study will be conducted, using valid and reliable methods and instrumentations, to determine if there are any effects of combined effect of early active 6 exercises and early weight bearing in treatment of patients with TPFs fixed with plates and screws which will add a new step in the pyramid of evidence for the best treatment methods for patients with TPFs fixed with plates and screws.

Conditions

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Tibial Plateau Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A triple-blinded clinical randomized trial: (the research assistant, the participants, and the statistician) will be blinded to the treatment groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
A triple-blinded clinical randomized trial: (the research assistant, the participants, and the statistician) will be blinded to the treatment groups.

Study Groups

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Group A will receive early active knee ROM exercises with weight 24 bearing.

Group A

Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist as follows:

Weeks: 1-4

The program will be applied according to (Mohamed et al., 2022) as follows:

Week: 1

Day: 1-2:

1. Static quadriceps, hamstrings and glutei.
2. Static abdominal and back exercises.
3. Active knee flexion and extension ROM exercises as possible according to patient tolerance and pain.

Day: 3-4:

In addition to the previous we add the following

1. Ankle toe movement.
2. Active exercises of the unaffected limb.
3. Respiratory exercises. 33
4. Cryotherapy.
5. Active assisted hip abduction (0° -10°).
6. Ankle toe movement; heel slides (0°-5°). Day: 5-7

In addition to previous exercises, the following exercises will be added:

1. Half bridging exercise.
2. Active SLR (0°-15°).
3. Active abduction (0°-15°).
4. Active adduction (15°-0°).
5. Heel slides (0°-10°). Weight bering excecises Ten percent of load on the affect leg

Group Type EXPERIMENTAL

Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist

Intervention Type OTHER

The difference between each group is in the first four weeks and the type of program group one started with active exercise from the first day 38 group 2 active exercises started from week five at the first four weeks program is done by passive ROM modalities and by the physiotherapist. Early weight bearing is early in group 1 from the first week and late in group 2 after four weeks

Group B will receive early passive ROM with delayed weight bearing.

Passive ROM will be applied from the first day according to (Arslan, A et al., 2015) and late weight bearing based on (Amin et al.,2023) as follows:

Weeks: 1-4

1. Cryotherapy for 10 minutes three times per day.
2. Passive exercises:

1. ROM exercises.
2. Passive ankle toe movements for 10 repetitions.
3. Passive knee flexion as tolerated The program will be applied without active participation from the patient. It will be applied by the physiotherapist.
3. Weight bearing is mainly in the sound side not affected so no weight bearing in the affected limb for about four weeks (Amin et al., 2023).

Weeks: 5-8 Same protocol as Group A. Weeks: 9-12 Same protocol as Group A. Weeks: 13-16 Same protocol as Group A. The difference between each group is in the first four weeks and the type of program group one started with active exercise from the first day 38 group 2 active exercises started from week five at the first four weeks program is done by passive ROM modalities and by the physiotherapis

Group Type ACTIVE_COMPARATOR

Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist

Intervention Type OTHER

The difference between each group is in the first four weeks and the type of program group one started with active exercise from the first day 38 group 2 active exercises started from week five at the first four weeks program is done by passive ROM modalities and by the physiotherapist. Early weight bearing is early in group 1 from the first week and late in group 2 after four weeks

Interventions

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Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist

The difference between each group is in the first four weeks and the type of program group one started with active exercise from the first day 38 group 2 active exercises started from week five at the first four weeks program is done by passive ROM modalities and by the physiotherapist. Early weight bearing is early in group 1 from the first week and late in group 2 after four weeks

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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mohmed yehia elabd hasan

phyisical therapist at qena oncology center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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enas fawzy mohamed, phd

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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faculty of physical therapy cairo university, Giza,

Giza, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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tibial plateau early rehab

Identifier Type: -

Identifier Source: org_study_id

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