Tibial Plateau FracturesNCT07251699
EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES
A study testing Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist in people with Tibial Plateau Fractures, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tibial Plateau Fractures
- What is being tested?
- Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion Criteria Participants will be included in the study if they had TPF type II Schatzker fixed with plate and screws. Their aged range from 18-50 years old while their BMI range from 18.5 to 29.9 kg/m2 (Mohamed et 25 al., 2019; Hoseini et al., 2022; Phansopkar et al., 2022). They are referred from an orthopedic surgeon immediately after the operation.
- Exclusion Criteria Participants will be excluded from this study if they didn't fulfil the inclusion criteria or if they had one of the following. Other types of TPFs or methods of fixation, previous hip or lower extremity injury or surgery e.g. arthroplasty, systemic diseases e.g. diabetes, rheumatoid arthritis, pathological conditions of the lower extremities e.g. tumours, infections, leg deformity, cardiovascular disease such as hypertension, and neurological diseases.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of physical therapy cairo university, Giza,
Giza, Giza Governorate
About this study
Official title: COMBINED EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES WITH INTERNAL FIXATION
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?
Read the detailed description
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
- Tibial Plateau Fractures
- Being tested
- Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist
- Keywords
- early reabilitation
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapistOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
This scale will be used to measure pain intensity. It is a valid and reliable scale for pain intensity measurement, (
Measured: 5 min
Modified Rasmussen Radiologic Score
This chart is valid measurement tool for assessing fracture healing
Measured: 5 min
Secondary outcomes (2)
Universal Goniometer
This tool will be used to measure ROM of knee flexion and extension. The goniometer is a 360° protractor with one axis that joins two arms; a stationary arm and a movable one around the fulcrum of the protractor, (Figure 6). It is a valid and reliable tool in measurement of knee ROM (Acar et al., 2024).
Measured: 5 min
Arabic version of the Knee injury and Osteoarthritis Outcome Score (KOOS)
This scale will be used to assess function. The KOOS scale's creators demonstrated the scale has excellent internal consistency, test-retest reliability, construct validity. In addition, it has responsiveness to variations in bodily function (Torad, A et al., 2015). The KOOS-AR is a valid indicator of activity limitation brought on by musculoskeletal problems of the lower 27 extremities. It also has excellent internal consistency and test-retest reliability with relatively small measurement error, (Appendix II), (Almangoush,.,et al., 2013).
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FracturesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A triple-blinded clinical randomized trial: (the research assistant, the participants, and the statistician) will be blinded to the treatment groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohmed yehia elabd hasan, Cairo University
- Investigators
- enas fawzy mohamed, phd, Principal investigator, Enas.fawzy@pt.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251699
- Sponsor's protocol ID
- tibial plateau early rehab
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBINED EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES WITH INTERNAL FIXATION
- ClinicalTrials.gov ID
- NCT07251699
- Acronym / sponsor ID
- tibial plateau early rehab
- Conditions
- Tibial Plateau Fractures
- Keywords
- early reabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A triple-blinded clinical randomized trial: (the research assistant, the participants, and the statistician) will be blinded to the treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Group A will receive early active knee ROM exercises with weight 24 bearing. | Experimental | Other: Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapistGroup 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 B will receive early passive ROM with delayed weight bearing. | Active comparator | Other: Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapistPassive 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 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Inclusion Criteria Participants will be included in the study if they had TPF type II Schatzker fixed with plate and screws. Their aged range from 18-50 years old while their BMI range from 18.5 to 29.9 kg/m2 (Mohamed et 25 al., 2019; Hoseini et al., 2022; Phansopkar et al., 2022). They are referred from an orthopedic surgeon immediately after the operation.
- Exclusion Criteria Participants will be excluded from this study if they didn't fulfil the inclusion criteria or if they had one of the following. Other types of TPFs or methods of fixation, previous hip or lower extremity injury or surgery e.g. arthroplasty, systemic diseases e.g. diabetes, rheumatoid arthritis, pathological conditions of the lower extremities e.g. tumours, infections, leg deformity, cardiovascular disease such as hypertension, and neurological diseases.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapistThe 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 | Other | Group A will receive early active knee ROM exercises with weight 24 bearing., Group B will receive early passive ROM with delayed weight bearing. |
Primary outcome
Numerical Pain Rating Scale
Time frame: 5 min
This scale will be used to measure pain intensity. It is a valid and reliable scale for pain intensity measurement, (
Modified Rasmussen Radiologic Score
Time frame: 5 min
This chart is valid measurement tool for assessing fracture healing
2 secondary outcomes
Universal Goniometer
Time frame: 5 min
Arabic version of the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 5 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
enas fawzy mohamed, phd principal investigator
Enas.fawzy@pt.cu.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist in people with Tibial Plateau Fractures, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: 5 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.