- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06838858
Effects of Motor Imagery Training After Muscle Lengthening Surgery in Children with Cerebral Palsy
Investigation of the Early Effects of Motor Imagery Training on Balance, Walking and Quality of Life After Ankle Plantar Flexor Muscle Lengthening Surgery in Children with Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is a pathology that occurs as a result of a non-progressive lesion in the brain that develops due to various risk factors that may occur before, during, or after birth. The spastic type is the most common type of CP. Children with CP experience various problems in physical, psychological, mental, and social areas depending on the affected area of the brain and the degree of involvement. Motor function losses are the primary problem in individuals with CP. Children are classified according to the level of involvement with the gross motor function scale (GMFCS). While GMFCS level 1 indicates the mildest involvement, GMFCS level 5 indicates the most severe involvement.
Spasticity that occurs in the affected areas of the body after upper motor neuron lesions directly negatively affects the child's muscle and joint functions. The muscle groups where spasticity is commonly and frequently seen in the lower extremities are the hip adductor muscles, hamstrings, and ankle plantar flexor muscles. Ankle plantar flexor muscle spasticity can be seen in children of all GMFCS levels and negatively affects the child's functional status and reduces compliance with orthosis use. Increased ankle plantar flexor spasticity causes contracture in the ankle plantar flexors over time, which restricts ankle dorsiflexion. This condition often causes toe walking in children. Toe walking disrupts the child's general body balance and also negatively affects other upper segments, especially the knee joint.
The primary treatment option in the presence of ankle plantar flexor muscle spasticity is conservative treatment. Conservative treatment includes positioning the ankle in dorsiflexion and strengthening the dorsiflexor muscles, stretching the ankle plantar flexor muscles, performing relaxation exercises on the same muscle group, transferring weight in the appropriate position, and walking exercises.
In addition, in the presence of dynamic spasticity, the effectiveness of botulinum neurotoxin injection applied to the ankle plantar flexor muscles in cases where conservative treatment is inadequate has been shown in the literature. In cases where all these methods are inadequate, plantar flexor muscle contracture is present, and the child is functionally negatively affected, lengthening surgeries performed on the plantar flexor muscles are indicated. This operation can be performed only on the gastrocnemius muscle or on the Achilles tendon, which includes both the gastrocnemius and soleus muscles.
The ankle plantar flexor muscles are included in the antigravity muscle group and have an important role in general body balance. The length and strength of these muscles at a certain rate provide stabilization of the body segments. While the increased tone of these muscles disrupts this stabilization, the inability of the elongated muscle to provide sufficient core support after relaxations results in excessive dorsiflexion and suggests that it may cause walking problems and ultimately loss of balance. Therefore, when deciding on plantar flexor muscle relaxation operations applied to children with CP, it is thought that the right timing should be provided and the surgery should be performed with an experienced team in sufficient and correct amounts, and post-operative rehabilitation protocols that include intensive studies on gaining balance and stabilization in the post-operative period will increase balance and walking control.
Motor Imagery; It is the process of learning a new movement or increasing the quality of a known movement by visualizing it in a planned and intensive manner in the mind without performing any motor activity. In imagery, while not actually doing any activity; it is possible to experience it through mental imagery by seeing the image in the mind, feeling the movement as in the image, sensing the taste or smell of the image, and hearing its sound. The effectiveness of motor imagery training has been shown in children with CP. There is no study on its effectiveness in the postoperative period.
This study hypothesizes that motor imagery training, which will be applied in addition to the post-operative rehabilitation program, is effective on balance, walking, and quality of life, especially in children with CP, in the rehabilitation process where there is a mandatory restriction with plaster and orthosis after ankle plantar flexor muscle lengthening surgeries. The primary aim of this study is to examine the effect of motor imagery training, which will be applied in addition to post-operative rehabilitation after ankle plantar flexor muscle release operations in individuals with CP, on balance, gait, and quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis with Cerebral Palsy
- Being between the ages of 7-18
- Being able to walk with or without support
- Not having received botulinum toxin injections into the ankle plantar flexor muscles in the last 6 months
- Being at the GMFCS level of 1,2 or 3
- Having an indication for ankle muscle release surgery and having a surgical plan
- Being receiving a developmental rehabilitation program
- Being able to follow given commands
Exclusion Criteria:
- Having dyskinetic, ataxic or hypotonic involvement
- Having any neurosurgery before
- Having any bone surgery for the foot or ankle before
- Having a bone surgery in the same session
- Mental retardation and not being able to take commands
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Post-Operative Exercise Group
This group will be included in a conventional post-operative rehabilitation program that includes intensive foot intrinsic muscle balance, bilateral ankle strengthening and range of motion exercises, and general body balance studies after plantar flexor muscle relaxation operations.
In the rehabilitation program of the case group, exercises are planned under the supervision of a remote physiotherapist, with the telerehabilitation method (online live sessions) 2 days and 1 face to face therapy session will be done in a week.
face therapy sessions and 16 telerehabilitation sessions.
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This group will receive conventional exercises in the post-op process. The exercises included in the conventional exercise program are;
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Active Comparator: Motor Imagery Training Group in Addition to Post-Operative Exercise
The study group will receive motor imagery exercises in addition to the post-op rehabilitation received by the comparison group. The exercises will given in a hibrit method (a face to face therapy session and 2 telerehabilitation session in an online platform in a week). The telerehabilitation sessions will given under the supervision of a remote physiotherapist. This group will take therapy sessions during 8 weeks. All the patients will have totally 8 face to face therapy sessions and 16 telerehabilitation sessions. |
This group will receive conventional exercises in the post-op process. The exercises included in the conventional exercise program are;
The study group will receive motor imagery training in addition to control group's exercise program.
This process will proceed as follows; In motor imagery training videos taken with a 9-year-old healthy child will be watched.•
The content of the videos will include exercises such as ankle dorsiflexion, heel tapping while walking, climbing and descending stairs, walking on a ramp, standing on a ramp, walking on soft ground, and walking on a treadmill.•
The patients will watch these videos and then the relaxation, imagination and return to environment phases of motor imagery will be applied respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion Measurement
Time Frame: Baseline, week 4, week 8
|
Range of Motion will be measured with using an universal goniometer for knee and ankle.
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Baseline, week 4, week 8
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Muscle Strength
Time Frame: Baseline, week 4, week 8
|
Manuel muscle testing will be done.
It will graded 0 to 5. Five represents full strength.
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Baseline, week 4, week 8
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Gait Assessment
Time Frame: Baseline and week 8
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It will be asseessed with using Edinburg Visual Gait Scorring (EVGS). EVGS is a video based gait scorring system. It consist of 17 items. A gait video will be taken from sagital and coronal plan. It will scorred later. Additionally, pedobarographic measurements for temporospatial gait parameters will be obtained with Enertor foot scanning system (RSscan Lab Ltd; UK). The temporospatial gait parameters are; step length, stride length, Step width, cadance, double support time, single support time. |
Baseline and week 8
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Balance Assessment
Time Frame: Baseline, week 8
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It will done by using Pediatric Balance Scale. There are 14 items in this scale. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills during tasks that mimic experiences of everyday living in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. Additionally, pedobarographic measurements for static balance assessment will be obtained with Enertor foot scanning system (RSscan Lab Ltd; UK). |
Baseline, week 8
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Quality of Life Assessment
Time Frame: Baseline and week 8
|
Quality of life assessments of patients will be made using the Quality of Life Scale for Children.
The first version of the scale (PedsQL TM 1.0) is a general quality of life scale developed for use in various pediatric populations.
The most powerful version, the fourth version's core scale (PedsQL TM 4.0 Generic Core Scale), is a scale that evaluates the basic physical, mental and social health components determined by the World Health Organization in healthy children or those with acute or chronic diseases, together with school functionality.
This scale consists of a total of 23 items and 4 subscales, including 8 items measuring physical functionality, 5 items measuring emotional functionality, 5 items measuring social functionality and 5 items evaluating school functionality.
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Baseline and week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional Mobility
Time Frame: Baseline, week 4, week 8
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Functional status and ambulation assessment of patients will be made with the Functional Mobility Scale (FMS).
The Functional Mobility Scale is a scale that evaluates how patients walk 5, 50 and 500 meters and ultimately divides them into 6 groups.
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Baseline, week 4, week 8
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Foot pressure measurement
Time Frame: Baseline and week 8
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The pedobarograph is a device displaying and recording the instantaneous distribution of the pressure under the entire surface of the soles of the feet.
The subject stands or walks on a transparent plate, in which light is conducted by total internal reflections.
For the assessment of foot pressure, pedobarographic measurements will be obtained with the Enertor foot scanning system (RSscan Lab Ltd; UK).
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Baseline and week 8
|
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Movement imagery
Time Frame: Baseline, week 8
|
It will be assessed by usisng Movement imagery questionnaire for children-MIQ-C.
This questionnaire was used to measure visual (internal, external skills) and kinesthetic imagery.
It contains a total of 12 items, 4 items internal, 4 items external, and 4 items kinesthetic imagery skills.
Within the scope of the questionnaire, the individual is asked to imagine 4 different movements from 3 different visual perspectives.
During this test applied with the evaluator, the individual is asked to do the movement in the instructions once in reality and then to imagine doing the movement, and the clarity of this imagery is scored using a Likert-type scale between 1 (very difficult to feel) and 7 (very easy to feel).
The questionnaire was developed by Martini et al..
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Baseline, week 8
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Motor Imagery Training Fun and Clarity
Time Frame: After each therapy sessions
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An additional evaluation will be made with the Motor Imagery Training Fun and Clarity Scale.
The fun level of motor imagery sessions and imagery training for individuals will be evaluated using a 0-10 point numerical rating scale (fun scale).
There will be numbers from 0 to 10 on a 10 cm horizontal line.
On the scale, 0 on the line means "not fun at all" and 10 means "very fun".
The degree of fun will be recorded numerically between 0 and 10.
Similarly, how clearly they can visualize the tasks imagined during the imagery sessions will be evaluated with a 0-10 point numerical rating scale (clarity scale).
Individuals will be asked to evaluate clarity by stating that 0 on a 10 cm horizontal line means that imagery is not clear at all, and 10 means it is very clear.
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After each therapy sessions
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zuhal Didem Takinacı, PhD, Saglik Bilimleri Universitesi
Publications and helpful links
General Publications
- Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
- Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Steenbergen B, Craje C, Nilsen DM, Gordon AM. Motor imagery training in hemiplegic cerebral palsy: a potentially useful therapeutic tool for rehabilitation. Dev Med Child Neurol. 2009 Sep;51(9):690-6. doi: 10.1111/j.1469-8749.2009.03371.x.
- Decety J. The neurophysiological basis of motor imagery. Behav Brain Res. 1996 May;77(1-2):45-52. doi: 10.1016/0166-4328(95)00225-1.
- Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20. doi: 10.1097/00004694-200409000-00011.
- Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain measurement: a ratio measure? Pain Pract. 2003 Dec;3(4):310-6. doi: 10.1111/j.1530-7085.2003.03034.x.
- Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.
- 29. Crichton, N. (2001). Visual analogue scale (VAS). J Clin Nurs, 10(5), 706-6.
- 28. Doussoulin, A., & Rehbein, L. (2011). Motor imagery as a tool for motor skill training in children. Motricidade, 7(3), 37-43.
- Ottenbacher KJ, Taylor ET, Msall ME, Braun S, Lane SJ, Granger CV, Lyons N, Duffy LC. The stability and equivalence reliability of the functional independence measure for children (WeeFIM). Dev Med Child Neurol. 1996 Oct;38(10):907-16. doi: 10.1111/j.1469-8749.1996.tb15047.x.
- Xu C, Wen XX, Huang LY, Shang L, Cheng XX, Yan YB, Lei W. Normal foot loading parameters and repeatability of the Footscan(R) platform system. J Foot Ankle Res. 2017 Jul 17;10:30. doi: 10.1186/s13047-017-0209-2. eCollection 2017.
- 22. Abd El-Raheem, R. M., Kamel, R. M., & Ali, M. F. (2015). Reliability of using Kinovea program in measuring dominant wrist joint range of motion. Trends in Applied Sciences Research, 10(4), 224.
- Read HS, Hazlewood ME, Hillman SJ, Prescott RJ, Robb JE. Edinburgh visual gait score for use in cerebral palsy. J Pediatr Orthop. 2003 May-Jun;23(3):296-301.
- Rodda JM, Graham HK, Carson L, Galea MP, Wolfe R. Sagittal gait patterns in spastic diplegia. J Bone Joint Surg Br. 2004 Mar;86(2):251-8. doi: 10.1302/0301-620x.86b2.13878.
- 19. Palisano, R., Rosenbaum, P., Bartlett, D., Livingston, M., Walter, S., & Russell, D. (2007). GMFCS-E&R. CanChild Centre for Childhood Disability Research, McMaster University, 200(7).
- Verschuren O, Ketelaar M, Takken T, Van Brussel M, Helders PJ, Gorter JW. Reliability of hand-held dynamometry and functional strength tests for the lower extremity in children with Cerebral Palsy. Disabil Rehabil. 2008;30(18):1358-66. doi: 10.1080/09638280701639873.
- Boone DC, Azen SP, Lin CM, Spence C, Baron C, Lee L. Reliability of goniometric measurements. Phys Ther. 1978 Nov;58(11):1355-60. doi: 10.1093/ptj/58.11.1355.
- 15. Cohen, J, (1988), Statistical Power Analysis for the behavioral sciences, 2. Edition, Taylor & Francis INC, New York, US.)
- Kay RM, Rethlefsen SA, Ryan JA, Wren TA. Outcome of gastrocnemius recession and tendo-achilles lengthening in ambulatory children with cerebral palsy. J Pediatr Orthop B. 2004 Mar;13(2):92-8. doi: 10.1097/00009957-200403000-00006.
- Ruzbarsky JJ, Scher D, Dodwell E. Toe walking: causes, epidemiology, assessment, and treatment. Curr Opin Pediatr. 2016 Feb;28(1):40-6. doi: 10.1097/MOP.0000000000000302.
- Cottalorda J, Gautheron V, Metton G, Charmet E, Chavrier Y. Toe-walking in children younger than six years with cerebral palsy. The contribution of serial corrective casts. J Bone Joint Surg Br. 2000 May;82(4):541-4. doi: 10.1302/0301-620x.82b4.10188.
- Tardieu C, Lespargot A, Tabary C, Bret MD. Toe-walking in children with cerebral palsy: contributions of contracture and excessive contraction of triceps surae muscle. Phys Ther. 1989 Aug;69(8):656-62. doi: 10.1093/ptj/69.8.656.
- Schlough K, Andre K, Owen M, Adelstein L, Hartford MC, Javier B, Kern R. Differentiating Between Idiopathic Toe Walking and Cerebral Palsy: A Systematic Review. Pediatr Phys Ther. 2020 Jan;32(1):2-10. doi: 10.1097/PEP.0000000000000659.
- Yan Y, Fu X, Xie X, Ji S, Luo H, Yang F, Zhang X, Yang S, Xie P. Hip Adductor Intramuscular Nerve Distribution Pattern of Children: A Guide for BTX-A Treatment to Muscle Spasticity in Cerebral Palsy. Front Neurol. 2019 Jun 14;10:616. doi: 10.3389/fneur.2019.00616. eCollection 2019.
- Compagnone E, Maniglio J, Camposeo S, Vespino T, Losito L, De Rinaldis M, Gennaro L, Trabacca A. Functional classifications for cerebral palsy: correlations between the gross motor function classification system (GMFCS), the manual ability classification system (MACS) and the communication function classification system (CFCS). Res Dev Disabil. 2014 Nov;35(11):2651-7. doi: 10.1016/j.ridd.2014.07.005. Epub 2014 Jul 23.
- Papavasiliou AS. Management of motor problems in cerebral palsy: a critical update for the clinician. Eur J Paediatr Neurol. 2009 Sep;13(5):387-96. doi: 10.1016/j.ejpn.2008.07.009. Epub 2008 Sep 7.
- Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316. doi: 10.1111/dmcn.12662.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCDT-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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