Bone Deformity Clinical Trial
Official title:
Open Versus Closed Kinetic Chain Exercises in Tibial Distraction Osteogenesis by Ilizarov's METHOD
NCT number | NCT01738113 |
Other study ID # | Youssef1 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | December 2014 |
Verified date | June 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Ilizarov external fixator is an external skeletal fixator that is used to stabilize or
lengthen the limb bones. Bone lengthen bone occurs through mechanical distraction on the long
axis of the bone, thus the method of lengthening is called distraction osteogenesis. This
method has been shown successful. Unfortunately, it has also been associated with a
substantial number of complications.
Muscle shortening and persistent weakness are among the most common complications seen in
this procedure. Muscle shortening usually occurs in strong muscle groups such as the planter
flexor muscles, as a result of strength imbalance between the opposing muscle groups.
Shortening may persist for more than a year after the removal of the fixator and may require
surgical intervention. Fortunately, muscular shortening can be prevented by splinting and
physiotherapy in the form of stretching and strengthening exercise and functional training.
The use of different exercises in rehabilitation can help accomplishing different therapeutic
goals. Thus, the choice to use one or the other should depend on the desired treatment goals.
Weight bearing (CKC) and non weight bearing (OKC) exercise has been incorporated into
rehabilitation; however, the effects of these two types of exercises particularly on muscle
flexibility and mechanics have never been studied systematically.
Therefore, the purpose of this is to compare the effects of OKC and the CKC exercise on
muscle strength, architecture and flexibility.
General Hypothesis:
The use of open kinetic or closed kinetic chain exercises will have no different effects on
muscle function or internal organization during tibial distraction osteogenesis by Ilizarov's
method Specific hypotheses
1. There will be no difference between the effects of OKC and CKC on muscle flexibility.
2. There will be no difference between the effect of OKC and CKC exercises on muscle
strength.
3. There will be no difference between the effect of OKC and CKC on the internal
organization of muscle specifically the pennation angle, muscle thickness and fiber
length.
4. There will be no difference between the overall of OKC and CKC exercise on the
functional performance of patients.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Referred from an orthopedic surgeon with diagnosis of tibial lengthening or deformity correction by Ilizarov's external fixator. - unilateral or bilateral tibial distraction osteogenesis. Exclusion Criteria: - Patients with Ilizarov due to neurological causes (e.g. poliomyelitis) or other neuromusculoskeletal disease that could affect muscle function and innervations. - Ankle or knee joints are included in the Ilizarov frame. - Patients developed neurological complications that interfere with rehabilitation after the application of the Ilizarov apparatus. |
Country | Name | City | State |
---|---|---|---|
Egypt | The University of Banha | Banha |
Lead Sponsor | Collaborator |
---|---|
Aliaa Rehan Youssef |
Egypt,
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Ilizarov tension stress
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | peak isometric strength of the ankle plantar flexors | Then Isometric strength of the ankle plantar flexors will be measured using an isometric test in which the patients push maximally against the plate and the piston of the hand-held dynamometer for four to five seconds. Three measurements will be taken, with only maximum value used for statistical analysis | september 2013 (10 months) | |
Secondary | Ultrasonography for measuring internal muscle structure | For each patient, images of medial gastrocnemius will be taken bilaterally with the ankle joint at neutral position and at maximum plantar flexion, while the subtalar position is neutral. Imaging will be repeated while the muscle is relaxed and contracting by the same radiologist. The recorded scans will be used to measure Pennation angle, muscle thickness and fiber length using computer software | September 2013 (10 months) | |
Secondary | Ankle plantar flexors flexibility | The flexibility of the gastrocnemius and the soleus muscles will be assessed passively with the knee extended and flexed, respectively. Patient will assume the supine lying position during the testing. The investigator will measure the range of ankle dorsiflexion achieved using a digital inclinometer | September 2013 (10 months) |
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