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

NCT01738113 | Completed Phase 2

• 1 other identifier: Youssef1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.There will be no difference between the effects of OKC and CKC on muscle flexibility.
2. 2.There will be no difference between the effect of OKC and CKC exercises on muscle strength.
3. 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. 4.There will be no difference between the overall of OKC and CKC exercise on the functional performance of patients.

Conditions

Limb Length Discrepancy; Bone Deformity

Keywords

Ilizarov; distraction osteogenesis; Muscle architecture; muscle mechanics; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ultrasonography for measuring internal muscle structure

  September 2013 (10 months)

• Ankle plantar flexors flexibility

  September 2013 (10 months)

Study Arms (2)

open kinetic chain exercise

EXPERIMENTAL

Open kinetic chain exercise

Other: Open Kinetic Chain exercise

Closed Kinetic chain exercise

EXPERIMENTAL

Closed kinetic chain exercise

Other: Closed kinetic chain exercise

Interventions

Open Kinetic Chain exercise OTHER

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

open kinetic chain exercise

Closed kinetic chain exercise OTHER

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

Closed Kinetic chain exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Referred from an orthopedic surgeon with diagnosis of tibial lengthening or deformity correction by Ilizarov's external fixator.
• unilateral or bilateral tibial distraction osteogenesis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aliaa Rehan Youssef: lead

Study Sites (1)

The University of Banha

Banhā, Egypt

Location

Related Publications (26)

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  PMID: 8876574 BACKGROUND

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

  BACKGROUND

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• Paley D. Problems, obstacles, and complications of limb lengthening by the Ilizarov technique. Clin Orthop Relat Res. 1990 Jan;(250):81-104.

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• Schep NW, van Lieshout EM, Patka P, Vogels LM. Long-term functional and quality of live assessment following post-traumatic distraction osteogenesis of the lower limb. Strategies Trauma Limb Reconstr. 2009 Dec;4(3):107-12. doi: 10.1007/s11751-009-0070-3. Epub 2009 Nov 24.

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• Shyam AK, Song HR, An H, Isaac D, Shetty GM, Lee SH. The effect of distraction-resisting forces on the tibia during distraction osteogenesis. J Bone Joint Surg Am. 2009 Jul;91(7):1671-82. doi: 10.2106/JBJS.G.01238.

  PMID: 19571090 BACKGROUND

• Ilizarov tension stress

  BACKGROUND

• The principles of the Ilizarov method

  BACKGROUND

• Ilizarov GA. The tension-stress effect on the genesis and growth of tissues: Part II. The influence of the rate and frequency of distraction. Clin Orthop Relat Res. 1989 Feb;(239):263-85.

  PMID: 2912628 BACKGROUND

• Ilizarov GA. The tension-stress effect on the genesis and growth of tissues. Part I. The influence of stability of fixation and soft-tissue preservation. Clin Orthop Relat Res. 1989 Jan;(238):249-81.

  PMID: 2910611 BACKGROUND

• Ilizarov GA. Clinical application of the tension-stress effect for limb lengthening. Clin Orthop Relat Res. 1990 Jan;(250):8-26.

  PMID: 2403497 BACKGROUND

• Ilizarov GA, Shchurov VA. [Effect of stretching tension on the biomechanical properties of the muscles, their blood supply and the growth of the leg]. Fiziol Cheloveka. 1988 Jan-Feb;14(1):26-32. No abstract available. Russian.

  PMID: 3169414 BACKGROUND

• Ilizarov GA. Some possibilities with our method for treating damage to and disorders of locomotor apparatus. J Craniofac Surg. 1995 Sep;6(5):352-4; discussion 355. doi: 10.1097/00001665-199509000-00002. No abstract available.

  PMID: 9020712 BACKGROUND

Study Officials

• Aliaa Rehan Youssef, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Khaled Ayad, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Gamal A hosny, PhD

  Benha University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Orthopedic Physical therapy

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

EG (1)