Hippotherapy Simulator in Children With Cerebral Palsy

NCT04378036 | Completed

• 1 other identifier: MarHippos
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to research the effects of hippotherapy simulator in children with Cerebral Palsy. In order to evaluate its effectiveness, assessment of gross motor functions, lower extremity functions, muscle tone and spasticity, trunk control, sitting and standing balance, walking functions and functional independence were being applied.

Conditions

Rehabilitation; Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Hippotherapy; Postural Balance; Gait; Postural Control

Outcome Measures

Primary Outcomes (10)

• Gross Motor Function Classification System (GMFSS)

  Functional levels of participants were determined with the "Gross Motor Function Classification System" (GMFSS) before treatment. It is a system that classifies the gross motor functions of children with cerebral palsy. It classifies gross motor functions into five levels.

  Baseline

• Change in gross motor function from baseline to week 8 to week 16

  The gross motor functions of the participants were evaluated using Gross Motor Function Measure-88 (GMFM-88) before treatment, in the 8th week and the 16th week. It is a valid and reliable assessment tool widely used to evaluate motor functions in children with cerebral palsy. It consists of 88 items and includes 5 subsections: (A) lying and Rolling; (B) sitting; (C) crawling and kneeling; (D) standing; (E) walking, running and jumping.

  baseline, 8th. week, 16th. week

• Change in range of motion from baseline to week 8 to week 16

  The range of motion of the joints in the lower extremities was measured using the universal goniometer before treatment, in the 8th week and the 16th week.

  baseline, 8th. week, 16th. week

• Change in spasticity from baseline to week 8 to week 16

  Muscle spasticity of the lower limbs was evaluated with Modified Ashworth Scale (MAS) before treatment, in the 8th week and the 16th week. In the evaluations made with MAS, the muscle tone is rated between "0" and "4". "0" indicates that there is no increase in muscle tone, and "4" indicates that the affected part is rigid in flexion and extension.

  baseline, 8th. week, 16th. week

• Change in muscle tones of lower extremities from baseline to week 8 to week 16

  The tone, stiffness, and flexibility of the lower limb muscles were evaluated with the Myoton®PRO Digital Palpation Device before treatment, in the 8th week and the 16th week. It is an evidence-based Class 1 device (MDD Annex IX) that evaluates the biomechanical properties of soft biological tissues non-invasively, objectively, reliably, cheaply, quickly and easily.

  baseline, 8th. week, 16th. week

• Change in trunk postural control from baseline to week 8 to week 16

  The functional strength of the trunk, postural control and quality of trunk movements were evaluated with The Trunk Impairment Scale (TIS) before treatment, in the 8th week and the 16th week. TIS has been developed to evaluate the trunk of individuals with stroke and is a scale that has been adapted for use with children with cerebral palsy. TIS evaluates the body functionally in terms of strength in the sitting position. In addition, it evaluates the relationship between the body part and function by evaluating the body's static and dynamic balances and body coordination. It consists of three subsections: static, dynamic and coordination.

  baseline, 8th. week, 16th. week

• Change in dynamic and functional balance from baseline to week 8 to week 16.

  The dynamic and functional balances of the participants were evaluated with The Pediatric Balance Scale (PBS) before treatment, in the 8th week and the 16th week. PBS is an assessment tool adapted from the Berg Balance Scale (BDS) to evaluate children's functional balance in daily life activities. The scale consists of 14 sections and each section is scored between 0 and 4; the highest score that can be obtained from the scale is 56.

  baseline, 8th. week, 16th. week

• Change in dynamic balance in sitting and standing positions from baseline to week 8 to week 16

  Pedalo® Sensamove Balance Test Pro (Holz-Hoerz Gesellschaft mit beschränkter Haftung (GmbH), Germany) Software with miniboard was used to evaluate the dynamic balance functions of the participants during their sitting, standing position at the beginning, at the 8th and at the 16th week. This device has been developed to record the movements of the user in order to learn about the balance, response time and possible imbalances of the body.

  baseline, 8th. week, 16th. week

• The Functional Independence Measure (WeeFIM)

  The functional independence of children in daily activities was assessed with The Functional Independence Measure (WeeFIM) initially, at week 8 and at week 16. WeeFIM consists of 6 parts: self-care, sphincter control, mobility, locomotion, communication, and social communication, and a total of 18 activities are questioned. It is scored from 1 to 7 according to whether it receives help, performs on time or whether an auxiliary device is required when performing the function in each item.

  baseline, 8th. week, 16th. week

• Change in walking functions from baseline to week 8 to week 16

  Win-Track (Medicapteurs, France) path and software system was used to evaluate the walking functions (Spatio-temporal parameters) of participants at the beginning, in the 8th and the 16th week. Win-Track; static, posturography and gait analysis is a foot pressure-sensitive walking path that provides complete freedom in posture and movement acquisition. It records foot pressure up to 200 images per second during standing, walking or certain activities (such as sports movements, postural sequences) through 12.288 sensors on the Win-Track, which is in the form of a one-piece platform.

  baseline, 8th. week, 16th. week

Study Arms (2)

Neurodevelopmental Therapy Group

ACTIVE COMPARATOR

The number of participants in this group is 30. All participants were included in the rehabilitation program using only the Neurodevelopmental Therapy approach for 16 sessions (8 weeks x 2 days x 45 minutes).

Other: Neurodevelopmental Therapy

Hippotherapy Simulator Group

ACTIVE COMPARATOR

The same participants were taken into a rehabilitation program in which 16 sessions (8 weeks x 2 days a week) the Hippotherapy Simulator device (30 minutes) and Neurodevelopmental Therapy (NDT) (15 minutes) (HS + NDT method) were used together.

Other: Neurodevelopmental Therapy; Device: Hippotherapy Simulator

Interventions

Neurodevelopmental Therapy OTHER

The Neurodevelopmental Therapy rehabilitation program was determined according to the children's level of gross motor function, age, gender, mental state, and preferences. Neurodevelopmental Therapy program consists of the rehabilitation of muscle tone disorders, increasing sensory-perception-motor integrity, exercises to increase limb functions and body control, stretching and strengthening exercises for muscle shortness and weakness, exercises that include movements in daily life and training activities such as standing, walking, body care.

Hippotherapy Simulator Group; Neurodevelopmental Therapy Group

Hippotherapy Simulator DEVICE

Horse Riding Simulator (HRS) device was used as a hippotherapy simulator device. HRS is a device that moves forward, backward, backward-to-back, right-to-left swing and up-and-down swing in 3 dimensions, similar to the movements of a real horse, forming an 8-shaped movement on five axes. After the children sat in the saddle section, they were first taken to the warm-up speed program for 5 minutes, then to another one of the other speed levels (gradually moved to other speed levels as appropriate for the development and tolerance of children) and finally to the warm-up speed program for 5 minutes.

Hippotherapy Simulator Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Having a diagnosis of Spastic Cerebral Palsy
• Children aged between 5 - 18 years
• GMFCS level is I, II or III
• Independent seating
• Walking with at least 10 meters of independent, orthotic and/or auxiliary device
• Can understand simple verbal instruction
• Those with hip adductor muscle spasticity level less than 2 according to MAS
• Having bilateral passive hip abduction enough to could sit into the hippotherapy simulator device
• Voluntarily agreed to participate in the study

You may not qualify if:

• Those with hip dislocation
• Severe contracture or deformity to prevent the study
• Advanced scoliosis (above 20 degrees)
• Acute uncontrolled acute seizures
• Uncontrollable severe epileptic attacks
• Visual and auditory problems
• Injection of botulinum toxin in the last 6 months patients
• Underwent surgical operation such as muscle relaxation, tendon extension, and selective dorsal rhizotomy in the last 6 months

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Özdel Dilbade Özel Eğitim ve Rehabilitasyon Merkezi

Istanbul, Turkey (Türkiye)

Location

Related Publications (17)

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

• Garvey MA, Giannetti ML, Alter KE, Lum PS. Cerebral palsy: new approaches to therapy. Curr Neurol Neurosci Rep. 2007 Mar;7(2):147-55. doi: 10.1007/s11910-007-0010-x.

  PMID: 17324366 BACKGROUND

• 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.

  PMID: 18778959 BACKGROUND

• Zadnikar M, Kastrin A. Effects of hippotherapy and therapeutic horseback riding on postural control or balance in children with cerebral palsy: a meta-analysis. Dev Med Child Neurol. 2011 Aug;53(8):684-91. doi: 10.1111/j.1469-8749.2011.03951.x. Epub 2011 Mar 24.

  PMID: 21729249 BACKGROUND

• Meregillano G. Hippotherapy. Phys Med Rehabil Clin N Am. 2004 Nov;15(4):843-54, vii. doi: 10.1016/j.pmr.2004.02.002.

  PMID: 15458756 BACKGROUND

• Lee DR, Lee NG, Cha HJ, Yun Sung O, You SJ, Oh JH, Bang HS. The effect of robo-horseback riding therapy on spinal alignment and associated muscle size in MRI for a child with neuromuscular scoliosis: an experimenter-blind study. NeuroRehabilitation. 2011;29(1):23-7. doi: 10.3233/NRE-2011-0673.

  PMID: 21876292 BACKGROUND

• Lee CW, Kim SG, Na SS. The effects of hippotherapy and a horse riding simulator on the balance of children with cerebral palsy. J Phys Ther Sci. 2014 Mar;26(3):423-5. doi: 10.1589/jpts.26.423. Epub 2014 Mar 25.

  PMID: 24707098 BACKGROUND

• Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

  PMID: 9183258 BACKGROUND

• Palisano RJ, Hanna SE, Rosenbaum PL, Russell DJ, Walter SD, Wood EP, Raina PS, Galuppi BE. Validation of a model of gross motor function for children with cerebral palsy. Phys Ther. 2000 Oct;80(10):974-85.

  PMID: 11002433 BACKGROUND

• Glanzman AM, Swenson AE, Kim H. Intrarater range of motion reliability in cerebral palsy: a comparison of assessment methods. Pediatr Phys Ther. 2008 Winter;20(4):369-72. doi: 10.1097/PEP.0b013e31818b7994.

  PMID: 19011528 BACKGROUND

• Mutlu A, Livanelioglu A, Gunel MK. Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy. BMC Musculoskelet Disord. 2008 Apr 10;9:44. doi: 10.1186/1471-2474-9-44.

  PMID: 18402701 BACKGROUND

• Schneider S, Peipsi A, Stokes M, Knicker A, Abeln V. Feasibility of monitoring muscle health in microgravity environments using Myoton technology. Med Biol Eng Comput. 2015 Jan;53(1):57-66. doi: 10.1007/s11517-014-1211-5. Epub 2014 Oct 21.

  PMID: 25331739 BACKGROUND

• Saether R, Helbostad JL, Adde L, Jorgensen L, Vik T. Reliability and validity of the Trunk Impairment Scale in children and adolescents with cerebral palsy. Res Dev Disabil. 2013 Jul;34(7):2075-84. doi: 10.1016/j.ridd.2013.03.029. Epub 2013 May 1.

  PMID: 23643761 BACKGROUND

• 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.

  PMID: 17057441 BACKGROUND

• Kucukdeveci AA, Yavuzer G, Elhan AH, Sonel B, Tennant A. Adaptation of the Functional Independence Measure for use in Turkey. Clin Rehabil. 2001 Jun;15(3):311-9. doi: 10.1191/026921501676877265.

  PMID: 11386402 BACKGROUND

• Kim DY, Lim CG. Effects of Pedalo(R) training on balance and fall risk in stroke patients. J Phys Ther Sci. 2017 Jul;29(7):1159-1162. doi: 10.1589/jpts.29.1159. Epub 2017 Jul 15.

  PMID: 28744037 BACKGROUND

• Ramachandra P, Maiya AG, Kumar P. Test-retest reliability of the Win-Track platform in analyzing the gait parameters and plantar pressures during barefoot walking in healthy adults. Foot Ankle Spec. 2012 Oct;5(5):306-12. doi: 10.1177/1938640012457680. Epub 2012 Sep 5.

  PMID: 22956663 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Canan GÜNAY YAZICI, PhD(c)

  Marmara University Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Zübeyir SARI, Assoc Prof

  Marmara University Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD (c)

Model Details: Two different treatment methods were applied to the participants (n=30). Rehabilitation programs based on individual Neurodevelopmental Therapy were applied to the participants included in the study for eight weeks (first group). In the next eight weeks, the Hippotherapy Simulator system was applied to the same participants in addition to individual Neurodevelopmental Therapy-based rehabilitation programs (study group).

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: December 14, 2016
• Primary Completion: October 28, 2017
• Study Completion: October 28, 2017
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)