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

This study is not yet open for participant recruitment.
Verified November 2012 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Aliaa Rehan Youssef, Cairo University
ClinicalTrials.gov Identifier:
NCT01738113
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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 ostogenesis. 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 Intervention Phase
Bone Shortening
Bone Deformity
Other: Open Kinetic Chain exercise
Other: Closed kinetic chain exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open Versus Closed Kinetic Chain Exercises in Tibial Distraction Osteogenesis by Ilizarov's METHOD

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • peak isometric strength of the ankle plantar flexors [ Time Frame: september 2013 (10 months) ] [ Designated as safety issue: No ]
    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:
  • Ultrasonography for measuring internal muscle structure [ Time Frame: September 2013 (10 months) ] [ Designated as safety issue: No ]
    For each patient, images of medial gastrocnemuis 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

  • Ankle plantar flexors flexibility [ Time Frame: September 2013 (10 months) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738113

Locations
Egypt
The University of Benha Not yet recruiting
Benha, Egypt
Contact: ALAAELDIN KHAIRELDIN, MSC    +201111093600    alaaedin6879@hotmail.com   
Sub-Investigator: ALAAELDIN KHAIRELDIN, MSc         
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.

Responsible Party: Aliaa Rehan Youssef, Lecturer of Orthopedic Physical therapy, Cairo University
ClinicalTrials.gov Identifier: NCT01738113     History of Changes
Other Study ID Numbers: Youssef1
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Cairo University:
Ilizarov
distraction osteogenesis
Muscle architecture
muscle mechanics
Rehabilitation

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 15, 2014