AzTrials
AzTrials

Limb Length DiscrepancyPhase 2NCT01738113

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

A Phase 2 study testing Open Kinetic Chain exercise and Closed kinetic chain exercise in people with Limb Length Discrepancy and Bone Deformity, run by Aliaa Rehan Youssef at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Limb Length Discrepancy, Bone Deformity
What is being tested?
Open Kinetic Chain exercise and Closed kinetic chain exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
Jul 2014to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • The University of Banha

    Banhā

Other trials in Egypt

About this study

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.

Read more

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.
Read the detailed description

First, personal information and history of each subject will be collected. Then, patients will be informed and receive a full oral explanation of the purpose and procedures of the study before they will be asked to sign an informed consent form.

An initial assessment will be done at the end of latent period (5-7 days) and then every 2 weeks thereafter for a period of 3-5cm distraction or the end of distraction period whatever is earlier.

Patients enrolled in this study will be divided randomly into two groups (A \& B). Group A (OKC): will consist of 10 patients receiving open-kinetic- chain exercise program. Group B (CKC) will consist of 10 patients receiving closed-kinetic- chain exercise program.

Initially, each patient will be assessed using the Borg scale to determine the number of strengthening exercise repetitions that patient can carry out. Assessment will be repeated weekly, before the number of repetition is progressed. For stretching exercise, 5 repeat ions will be done each session, in addition patients will be asked to repeat the exercise as a home program exercise. Exercise will be given 3 times weekly, at the University of Benha outpatient clinic, for a period of 3-5 cm of distraction (approximately 8 weeks) or the end of distraction whatever is earlier Exercise for group (A) Knee flexion exercise Patient in supine and gently bend his knee, with keeping the heel in contact with the bed. Bring the heel towards bottom as far as is comfortable .Exercise will be repeated as determined by patient's ability.

Strength the hamstring muscle Patient will be in prone lying position with the knee free out of the bed. Patient will then be asked to bend his knee by making the heel touches his bottom.

Strength quadriceps muscle Patient will sit on the edge of bed or on chair with the thigh supported. Patient will be asked to keep his trunk upright. Then, the knee will be straightened and will be held with the toes pointing to the ceiling for 6 seconds.

Stretch hamstring from sitting:

Patients will assume the long sitting position with their non-operated extremity hanging over the edge of the bed. Patients will then lean forward, grasp his/her forefoot and dorsiflex the ankle while maintaining the knee extended. This position will be maintained for 20-60 seconds before returning to the starting position. The whole exercise will be repeated for 5 times.

Stretch hamstring from prone:

Patients will assume a prone lying position. The legs of the operated limb will be positioned in a neutral rotation and will be allowed to hang freely, over the edge of the bed, by the weight of leg and apparatus as well as by the pulling effect of the gravity. This position will be maintained for duration ranges from 1 minute to as long as tolerated by every individual patient. Patients will also be instructed to assume this position frequently at home during some daily activities e.g. while watching television or reading a book.

Strength hip extensor and abductors:

Patient will be prone with extended knee. Patient will be asked to raise the lower limb upward with the knee extended. For abductor strengthening, the patient will be in a side lying position on the non-operated limb and will be asked to raise the upper limb upwards while the knee is kept straight.

Calf-muscles stretch:

To stretch the gastrocnemius, the patient's heel will be grasped while the knee is extended. Then, the calcaneus will be pulled caudally, with the thumb and fingers of the therapist, before the heads of the metatarsals are gently pushed upwards. The end position will be held for 20-60 seconds before rest is allowed.

Strength exercise for dorsiflexors plantar flexors Patient in long sitting using Theraband one end by his hands and the other end secure around metatarsal bone then the patient will perform plantar flexion against resistance of surgical tubing repeat 10 times.

Exercise for group (B) Wall slides Patient will stand with back against a wall, and feet straight in front of him. Patient then slide down keeping back against the wall, until becoming in a slight sitting position. Slide down only as far as patient feel comfortable. For the first few times patient do this knee exercise, hold the sitting position for a few seconds, then slide back up repeat 10 times.

Foot sliding from sitting While patient is sitting on a smooth surface, the patient pulls the heel of involved leg toward buttocks, flexing the knee as much as tolerable. Hold and straighten leg by sliding heel downward.

Hamstring and quadriceps co-contraction from sitting From a relaxed sitting position with both knees bent to 90 degrees, the patients will be instructed to press firmly on the ground. This exercise will also be done using a stepper machine. Patient was instructed to press rhythmically on the feet plate of a stepper machine, while maintaining the feet in complete contact with the plate, so that heels were vertical.

Bridging exercise:

Patient will assume the crock lying position. In this position, the knees were bent to 30-45 degrees while the feet are completely resting on the supporting surface by placing a firm wedge underneath the feet to accommodate them to the supporting surface. Then, patients will be instructed to raise their lower back and pelvis, while bearing weight on both lower limbs, until the thighs lies in line with pelvis and trunk.

Side-to side, forward and backward weight shifting:

Patient will assume an erect standing position. Both feet will be placed slightly apart with the operated limb placed parallel to, in front of and behind the sound side during side-to-side, forward and backward weight shifting exercise, respectively.

Sitting-to-standing:

Patient will assume a relaxed sitting position. The foot of the affected extremity will be placed initially in front, later, behind the other side. Patient will be instructed to assume the standing positing, while bearing as much weight as they can on their affected extremities.

Lunge exercise:

Patient will assume the forward lunge position. In this position, the affected limb will be placed in front of the other. The distance through which each subject lunged forward will be determined by each individual's leg length as the feet should be about 2 to 3 feet apart, depending on patient's leg length. Then, each subject will move from an upright standing position to the forward lunge position, and back to the starting position.

Squatting exercise:

Patient will be instructed to stand erect, between the parallel bars, with their feet parallel and slightly apart. While maintaining the back erect, they will be instructed to bend both knees slightly then to return back to the erect standing position by pushing against the feet.

Standing Toe Raises:

This exercise is more advanced than the seated toe raise, as it places the entire weight of the body on the exercised leg. Stand upright on both feet Push down through the toes lifting both heels off the ground

Standing Hamstring Stretch:

Patient will stand in front of an elevated surface. Place the operated leg on the surface, Lean forward from the hips until a gentle hamstring stretch is felt on the underside of the thigh. Once a gentle hamstring stretch is felt on the underside of the thigh, hold this position for 30 seconds

Being tested
Open Kinetic Chain exercise, Closed kinetic chain exercise
Keywords
Ilizarov, distraction osteogenesis, Muscle architecture, muscle mechanics, Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open Kinetic Chain exerciseOther

    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
  • Closed kinetic chain exerciseOther

    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
Study groups in NCT01738113
Study groupRoleWhat they receive
open kinetic chain exerciseExperimentalOpen kinetic chain exercise
Receives: Other: Open Kinetic Chain exercise
Closed Kinetic chain exerciseExperimentalClosed kinetic chain exercise
Receives: Other: Closed kinetic chain exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: september 2013 (10 months)

Secondary outcomes (2)
  1. 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

    Measured: September 2013 (10 months)

  2. 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

    Measured: September 2013 (10 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738113
Sponsor's protocol ID
Youssef1
Status last verified
Jun 2018
First submitted
28 Nov 2012
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Aagaard P, Andersen JL, Dyhre-Poulsen P, Leffers AM, Wagner A, Magnusson SP, Halkjaer-Kristensen J, Simonsen EB. A mechanism for increased contractile strength of human pennate muscle in response to strength training: changes in muscle architecture. J Physiol. 2001 Jul 15;534(Pt. 2):613-23. doi: 10.1111/j.1469-7793.2001.t01-1-00613.x.

    PubMed 11454977
  • Aggeloussis N, Giannakou E, Albracht K, Arampatzis A. Reproducibility of fascicle length and pennation angle of gastrocnemius medialis in human gait in vivo. Gait Posture. 2010 Jan;31(1):73-7. doi: 10.1016/j.gaitpost.2009.08.249. Epub 2009 Sep 22.

    PubMed 19775893
  • Aronson J, Harp JH. Mechanical forces as predictors of healing during tibial lengthening by distraction osteogenesis. Clin Orthop Relat Res. 1994 Apr;(301):73-9.

    PubMed 8156700
  • Augustsson J, Esko A, Thomee R, Svantesson U. Weight training of the thigh muscles using closed vs. open kinetic chain exercises: a comparison of performance enhancement. J Orthop Sports Phys Ther. 1998 Jan;27(1):3-8. doi: 10.2519/jospt.1998.27.1.3.

    PubMed 9440034
  • Bohannon RW. Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther. 1986 Feb;66(2):206-9. doi: 10.1093/ptj/66.2.206.

    PubMed 3945674
  • Blazevich AJ. Effects of physical training and detraining, immobilisation, growth and aging on human fascicle geometry. Sports Med. 2006;36(12):1003-17. doi: 10.2165/00007256-200636120-00002.

    PubMed 17123325
  • Coglianese DB, Herzenberg JE, Goulet JA. Physical therapy management of patients undergoing limb lengthening by distraction osteogenesis. J Orthop Sports Phys Ther. 1993 Mar;17(3):124-32. doi: 10.2519/jospt.1993.17.3.124.

    PubMed 8472076
  • Caiozzo VJ, Utkan A, Chou R, Khalafi A, Chandra H, Baker M, Rourke B, Adams G, Baldwin K, Green S. Effects of distraction on muscle length: mechanisms involved in sarcomerogenesis. Clin Orthop Relat Res. 2002 Oct;(403 Suppl):S133-45. doi: 10.1097/00003086-200210001-00016.

    PubMed 12394462
  • Dahl MT, Gulli B, Berg T. Complications of limb lengthening. A learning curve. Clin Orthop Relat Res. 1994 Apr;(301):10-8.

    PubMed 8156659
  • Fink B, Krieger M, Strauss JM, Opheys C, Menkhaus S, Fischer J, Ruther W. Osteoneogenesis and its influencing factors during treatment with the Ilizarov method. Clin Orthop Relat Res. 1996 Feb;(323):261-72. doi: 10.1097/00003086-199602000-00036.

    PubMed 8625590
  • Fitch RD, Thompson JG, Rizk WS, Seaber AV, Garrett WE Jr. The effects of the Ilizarov distraction technique on bone and muscle in a canine model: a preliminary report. Iowa Orthop J. 1996;16:10-9.

    PubMed 9129270
  • Ghoneem HF, Wright JG, Cole WG, Rang M. The Ilizarov method for correction of complex deformities. Psychological and functional outcomes. J Bone Joint Surg Am. 1996 Oct;78(10):1480-5. doi: 10.2106/00004623-199610000-00004.

    PubMed 8876574
  • Physiotherapy during Ilizarov fixation. Techniques Orthop; 5(4):61-65, 1990.

  • Green SA. Patient management during limb lengthening. Instr Course Lect. 1997;46:547-54. No abstract available.

    PubMed 9143998
  • Legerlotz K, Smith HK, Hing WA. Variation and reliability of ultrasonographic quantification of the architecture of the medial gastrocnemius muscle in young children. Clin Physiol Funct Imaging. 2010 May;30(3):198-205. doi: 10.1111/j.1475-097X.2010.00925.x. Epub 2010 Feb 23.

    PubMed 20184623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Open Kinetic Chain exercise and Closed kinetic chain exercise in people with Limb Length Discrepancy and Bone Deformity, run by Aliaa Rehan Youssef at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peak isometric strength of the ankle plantar flexors (time frame: september 2013 (10 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01738113, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in