Clinical trial NCT06838858: Effects of Motor Imagery Training After Muscle Lengthening Surgery in Children With Cerebral Palsy
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rehabilitation
Cerebral Palsy (CP)
Exercise
Tenotomy
Motor Imagery Training
Orthopedic Surgery
Keywords: Rehabilitation
Post-operative Rehabilitaton
Cerebral Palsy
Surgery
Tenotomy
Motor Imagery Training
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In children with cerebral palsy (CP), spasticity occurs in the muscles due to upper motor neuron lesions. The muscle groups that are mostly spastic in the lower extremity are; the hip adductor and flexors, hamstrings, and ankle plantar flexors. Spasticity in the ankle plantar flexor muscles of these muscle groups causes contracture over time and restricts ankle dorsiflexion. Limitations in ankle dorsiflexion present as toe walking problems, balance loss, and various functional difficulties in children. Children with spasticity of the ankle plantar flexor muscles gastrocnemius and soleus are initially treated conservatively with exercise and positioning. However, after contracture occurs, treatment is performed using surgical methods. Surgical release of plantar flexor muscles is a method that has been proven to be effective and is frequently applied in the clinic. This surgery aims to remove the ankle dorsiflexion joint range of motion restriction, prevent toe walking, and improve the functional status of the child. However, since the plantar flexor muscles are in the antigravity muscle group, excessive release of these muscles can cause loss of balance and crouch gait. Therefore, it is important for this surgery to be performed by an experienced surgical team at the right time and to provide an exercise protocol aimed at stabilization by working both muscle groups in the postoperative period. In addition, after these surgeries, the patient is immobilized with a cast and orthosis for a while and the patient's active and passive movements are restricted with these devices. Motor Imagery; It is the process of learning a new movement or improving the quality of a known movement by visualizing it in a planned and intensive way in the mind of the person without performing any motor activity. This study hypothesized that the motor imagery training in the early rehabilitation process with movement restrictions after plantar flexor muscle relaxation operations will be effective on the patient's balance, walking, and quality of life.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Range of Motion Measurement
timeFrame: Baseline, week 4, week 8
measure: Muscle Strength
timeFrame: Baseline, week 4, week 8
measure: Gait Assessment
timeFrame: Baseline and week 8
measure: Balance Assessment
timeFrame: Baseline, week 8
measure: Quality of Life Assessment
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Functional Mobility
timeFrame: Baseline, week 4, week 8
measure: Foot pressure measurement
timeFrame: Baseline and week 8
measure: Movement imagery
timeFrame: Baseline, week 8
measure: Motor Imagery Training Fun and Clarity
timeFrame: After each therapy sessions
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Zuhal Didem Takinacı, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 29. Crichton, N. (2001). Visual analogue scale (VAS). J Clin Nurs, 10(5), 706-6.
citation: 28. Doussoulin, A., & Rehbein, L. (2011). Motor imagery as a tool for motor skill training in children. Motricidade, 7(3), 37-43.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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).
citation: 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.
citation: 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.
citation: 15. Cohen, J, (1988), Statistical Power Analysis for the behavioral sciences, 2. Edition, Taylor & Francis INC, New York, US.)
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.