- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251699
EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES
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?
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza Governorate
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Giza, Giza Governorate, Egypt
- faculty of physical therapy cairo university, Giza,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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:
Day: 3-4: In addition to the previous we add the following
In addition to previous exercises, the following exercises will be added:
|
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
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|
Active Comparator: 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
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 |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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, (
|
5 min
|
|
Modified Rasmussen Radiologic Score
Time Frame: 5 min
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This chart is valid measurement tool for assessing fracture healing
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5 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Universal Goniometer
Time Frame: 5 min
|
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).
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5 min
|
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Arabic version of the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 5 min
|
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).
|
5 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: enas fawzy mohamed, phd, Enas.fawzy@pt.cu.edu.eg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- tibial plateau early rehab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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