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Open Versus Closed Kinetic Chain Exercises in Tibial Distraction Osteogenesis by Ilizarov's METHOD

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ClinicalTrials.gov Identifier: NCT01738113
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Limb Length Discrepancy Bone Deformity Other: Open Kinetic Chain exercise Other: Closed kinetic chain exercise Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open Versus Closed Kinetic Chain Exercises in Tibial Distraction Osteogenesis by Ilizarov's METHOD
Study Start Date : July 2014
Primary Completion Date : December 2014
Study Completion Date : December 2014

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: open kinetic chain exercise
Open kinetic chain exercise
Other: Open Kinetic Chain exercise
  1. Hamstrings strengthening exercise
  2. Quadriceps strengthening exercise
  3. Hamstrings stretch
  4. Hip extensors and abductors strengthening
  5. Calf-muscles stretching
  6. Strength exercise of ankle dorsiflexors & plantar flexors
Experimental: Closed Kinetic chain exercise
Closed kinetic chain exercise
Other: Closed kinetic chain exercise
  1. Foot sliding from sitting
  2. Seated Toe Raises
  3. Hamstrings and quadriceps co-contraction from sitting
  4. Bridging exercise
  5. Sitting-to-standing
  6. Side-to side, forward and backwards weight shifting
  7. Lunge exercise
  8. Squatting exercise
  9. Standing Toe Raises
  10. Standing Hamstrings Stretch


Outcome Measures

Primary Outcome Measures :
  1. peak isometric strength of the ankle plantar flexors [ Time Frame: september 2013 (10 months) ]
    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


Secondary Outcome Measures :
  1. Ultrasonography for measuring internal muscle structure [ Time Frame: September 2013 (10 months) ]
    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

  2. Ankle plantar flexors flexibility [ Time Frame: September 2013 (10 months) ]
    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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738113


Locations
Egypt
The University of Benha
Benha, Egypt
Sponsors and Collaborators
Aliaa Rehan Youssef
Investigators
Principal Investigator: Aliaa Rehan Youssef, PhD Cairo University
Principal Investigator: Khaled Ayad, PhD Cairo University
Study Director: Gamal A hosny, PhD Benha University
More Information

Publications:
Physiotherapy during Ilizarov fixation. Techniques Orthop; 5(4):61-65, 1990.
Ilizarov tension stress

Responsible Party: Aliaa Rehan Youssef, Lecturer of Orthopedic Physical therapy, Cairo University
ClinicalTrials.gov Identifier: NCT01738113     History of Changes
Other Study ID Numbers: Youssef1
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Aliaa Rehan Youssef, Cairo University:
Ilizarov
distraction osteogenesis
Muscle architecture
muscle mechanics
Rehabilitation