NCT07251699

Brief Summary

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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Nov 2024Nov 2026

Study Start

First participant enrolled

November 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

early reabilitation

Outcome Measures

Primary Outcomes (2)

  • Numerical Pain Rating Scale

    This scale will be used to measure pain intensity. It is a valid and reliable scale for pain intensity measurement, (

    5 min

  • Modified Rasmussen Radiologic Score

    This chart is valid measurement tool for assessing fracture healing

    5 min

Secondary Outcomes (2)

  • Universal Goniometer

    5 min

  • Arabic version of the Knee injury and Osteoarthritis Outcome Score (KOOS)

    5 min

Study Arms (2)

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

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

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy cairo university, Giza,

Giza, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Study Officials

  • enas fawzy mohamed, phd

    Enas.fawzy@pt.cu.edu.eg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
A triple-blinded clinical randomized trial: (the research assistant, the participants, and the statistician) will be blinded to the treatment groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A triple-blinded clinical randomized trial: (the research assistant, the participants, and the statistician) will be blinded to the treatment groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phyisical therapist at qena oncology center

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 26, 2025

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations