Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy

NCT03889262 | Unknown

• 1 other identifier: 09.2017.297
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to develop a simulated hippotherapy system controlled by electromyography (EMG) signals and investigate its effectiveness in children with cerebral palsy. In order to investigate its effectiveness evaluation of gross motor functions, lower extremity joint movements, spasticity of the lower extremities, functional independence, body movements, sitting and standing balance, muscle tone, stiffness and elasticity level, analysis of the walking are planned.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Physiotherapy and Rehabilitation; Hippotherapy; Balance

Outcome Measures

Primary Outcomes (10)

• Change in functional level from baseline, week 8 and week 16

  Functional level will be defined with Gross Motor Functional Classification System (GMFCS). GMFCS defines movements such as sitting, walking and use of mobility devices. It provides a clear description of a child's current gross motor functional level. Level I can climb stairs without the use of a railing. Level II can walk in most settings and climb stairs holding onto a railing. Level III needs usage of a hand held mobility device, may climb stairs holding onto a railing with assistance. Level IV requires physical assistance or powered mobility in most settings. Level V children are transported in a manuel wheelchair in all settings, they are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements.

  16 weeks

• Change in spasticity from baseline, week 8 and week 16

  Spasticity will be defined with Modified Ashworth Scale (MAS). The MAS measures resistance during passive soft-tissue stretching. Scoring: 0= normal tone. 1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension. 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM. 2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3= considerable increase in muscle tone, passive movement difficult. 4= affected part(s) rigid in flexion or extension.

  16 weeks

• Change in range of motion from baseline, week 8 and week 16

  Lower extremity Range of Motion (ROM) will be measured with universal goniometer.

  16 weeks

• Change in gross motor functional level from baseline, week 8 and week 16

  Gross motor function will be assessed with Gross Motor Function Measure-88. It consists of 88 items and contains 5 subdivisions: (A) reaching and turning; (B) sitting; (C) crawling and notebook; (D) standing; (E) walking, running and jumping. The total score and the scores of each sub-section are calculated. In our study, sections B, D and E will be evaluated.

  16 weeks

• Change in postural control from baseline, week 8 and week 16

  Trunk movements will be assessed with Trunk Impairment Scale (TIS). It will be used to evaluate the postural control. The scale is developed to evaluate the people with stroke and has been adapted and validated for the children with Cerebral Palsy (CP). The TIS assesses static and dynamic sitting balance and trunk coordination in a sitting position. The static subscale investigates the ability of the subject to maintain a sitting position with feet supported, while the legs are passively crossed, and when the subject crosses the legs actively. The dynamic subscale contains items on lateral flexion of the trunk and unilateral lifting of the hip. For each item, a 2, 3 or 4-point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

  16 weeks

• Change in functional independence from baseline, week 8 and week 16

  Functional Independence will be defined with The Functional Independence Measure for Children (WeeFim). WeeFim consists of 6 parts: self-care, sphincter control, mobility, locomotion, communication and social communication. Each item is scored from 1 to 7 depending on whether it receives help when performing the function, whether it is on time, or whether the auxiliary device is required. "1" means fully dependent, "7" means fully independent. According to this, the highest score a child can get is 126 and the lowest score is 18.

  16 weeks

• Change in functional balance from baseline, week 8 and week 16

  Balance will be defined with Pediatrics Balance Scale (PDS). It is an assessment tool adapted from the Berg Balance Scale (BDS) to evaluate the functional balance of children in daily living activities. The scale consists of 14 chapters and each section is scored between 0 and 4; the highest score is 56. PDS is a high-reliability scale between groups and test re-testing in school-age children with mild to moderate motor impairment. The scale is valid in children with Cerebral Palsy.

  16 weeks

• Change in soft tissue from baseline, week 8 and week 16

  Soft tissue assessment will assessed with Myoton® PRO device. It is an evidence-based device that evaluates the bio-mechanical properties of soft biological tissues in a non-invasive, objective, reliable, inexpensive, quick and easy manner. Myoton® PRO is used in studies to evaluate superficial skeletal muscles, connective tissues such as tendons and ligaments, and other soft tissues. It is a highly reliable method for assessing the tone, stiffness, elasticity of muscles.

  16 weeks

• Change in walking from baseline, week 8 and week 16

  Walking analysis will be assessed with FreeMed® (Sensör Medica) which is a baropodometric platform. The software program can perform postural evaluation and bio-mechanical analysis. Dynamic analysis software program allows walking analysis. It documents the results in curves and graphics, podalic geometry, walking cycle, numerical values, combination of forces and videography and records in computer environment.

  16 weeks

• Change in body balance change from baseline, week 8 and week 16

  Balance will be assessed with Pedalo® Balance Device. It will be used to evaluate the balance during sitting and standing positions. Pedalo® balance device has been developed to record the user's movements to provide information about the body's balance, response time and possible imbalances. Pedalo® is a device that provides performance improvement in terms of balance and coordination. The device not only measures the performance that appears, but also compares previous performances to allow the evaluation of all performances.

  16 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants in this group will receive only Neurodevelopmental therapy (NDT) based rehabilitation for 45 minutes in each session, twice a week, during 8 weeks, 16 sessions in total. Number of participants in this group is anticipated to be 20.

Other: Neurodevelopmental Therapy

Study Group

ACTIVE COMPARATOR

After 16 sessions (8 weeks) of only Neurodevelopmental therapy (NDT) based rehabilitation, simulated hippotherapy treatment will be added to rehabilitation program of the same participants. Their NDT treatment will be reduced to 25 minutes whereas hippotherapy will be applied for 20 minutes in each session, 2 sessions a week, 8 weeks in total.

Other: Hippotherapy; Other: Neurodevelopmental Therapy

Interventions

Hippotherapy OTHER

Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes.

Study Group

Neurodevelopmental Therapy OTHER

Neurodevelopmental therapy (NDT) is a hands-on treatment approach used by physical therapists, occupational therapists, and speech-language pathologists. NDT was developed to enhance the function of children who have difficulty controlling movement as a result of neurological challenges, such as cerebral palsy and head injury. During treatment interventions, repeated experience in movement ensures that a particular pattern is readily accessible for motor performance. The more a patient performs certain movements, the easier these movements becomes.

Also known as: Bobath Therapy

Control Group; Study 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,
• Gross motor functional level is I, II or III,
• Independent seating
• Walking at least 10 meters independently,
• Can understand simple verbal instructions,
• Those with a spasticity level less than 2 according to Modified Ashworth Scale ,
• Having bilateral hip abduction enough to sit on the hippotherapy device,
• Voluntary acceptance to participate in the study

You may not qualify if:

• Having hip dislocation,
• Severe contracture or deformity,
• Scoliosis (above 20 degrees),
• Acute uncontrolled acute seizures,
• Epilepsy,
• Visual and auditory problems,
• Injection of botulinum toxin in the last 6 months,
• History of surgical operation such as muscle relaxation, tendon extension and selective dorsal rhizotomy in the last 6 months.

Sponsors & Collaborators

• Marmara University: lead

Related Publications (20)

• Champagne D, Corriveau H, Dugas C. Effect of Hippotherapy on Motor Proficiency and Function in Children with Cerebral Palsy Who Walk. Phys Occup Ther Pediatr. 2017 Feb;37(1):51-63. doi: 10.3109/01942638.2015.1129386. Epub 2016 Mar 1.

  PMID: 26930110 BACKGROUND

• Han JY, Kim JM, Kim SK, Chung JS, Lee HC, Lim JK, Lee J, Park KY. Therapeutic effects of mechanical horseback riding on gait and balance ability in stroke patients. Ann Rehabil Med. 2012 Dec;36(6):762-9. doi: 10.5535/arm.2012.36.6.762. Epub 2012 Dec 28.

  PMID: 23342307 BACKGROUND

• Herrero P, Gomez-Trullen EM, Asensio A, Garcia E, Casas R, Monserrat E, Pandyan A. Study of the therapeutic effects of a hippotherapy simulator in children with cerebral palsy: a stratified single-blind randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1105-13. doi: 10.1177/0269215512444633. Epub 2012 May 18.

  PMID: 22610128 BACKGROUND

• Hosaka Y, Nagasaki M, Bajotto G, Shinomiya Y, Ozawa T, Sato Y. Effects of daily mechanical horseback riding on insulin sensitivity and resting metabolism in middle-aged type 2 diabetes mellitus patients. Nagoya J Med Sci. 2010 Aug;72(3-4):129-37.

  PMID: 20942267 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

• 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

• Kim SG, Lee JH. The effects of horse riding simulation exercise on muscle activation and limits of stability in the elderly. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):62-5. doi: 10.1016/j.archger.2014.10.018. Epub 2014 Nov 7.

  PMID: 25465508 BACKGROUND

• Kim SK, Kim SG, HwangBo G. The effect of horse-riding simulator exercise on the gait, muscle strength and muscle activation in elderly people with knee osteoarthritis. J Phys Ther Sci. 2017 Apr;29(4):693-696. doi: 10.1589/jpts.29.693. Epub 2017 Apr 20.

  PMID: 28533611 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

• 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

• 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 J, Yun CK. Effects of hippotherapy on the thickness of deep abdominal muscles and activity of daily living in children with intellectual disabilities. J Phys Ther Sci. 2017 Apr;29(4):779-782. doi: 10.1589/jpts.29.779. Epub 2017 Apr 20.

  PMID: 28533630 BACKGROUND

• Leveille A, Rochette A, Mainville C. Perceived risks and benefits of hippotherapy among parents of children currently engaged in or waiting for hippotherapy: A pilot study. Physiother Theory Pract. 2017 Apr;33(4):269-277. doi: 10.1080/09593985.2017.1302029. Epub 2017 Apr 5.

  PMID: 28379061 BACKGROUND

• Mutlu A, Livanelioglu A, Gunel MK. Reliability of goniometric measurements in children with spastic cerebral palsy. Med Sci Monit. 2007 Jul;13(7):CR323-9.

  PMID: 17599027 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

• 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

• Park JH, Shurtleff T, Engsberg J, Rafferty S, You JY, You IY, You SH. Comparison between the robo-horse and real horse movements for hippotherapy. Biomed Mater Eng. 2014;24(6):2603-10. doi: 10.3233/BME-141076.

  PMID: 25226963 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

• Silva e Borges MB, Werneck MJ, da Silva Mde L, Gandolfi L, Pratesi R. Therapeutic effects of a horse riding simulator in children with cerebral palsy. Arq Neuropsiquiatr. 2011 Oct;69(5):799-804. doi: 10.1590/s0004-282x2011000600014.

  PMID: 22042184 BACKGROUND

• Yi SH, Hwang JH, Kim SJ, Kwon JY. Validity of pediatric balance scales in children with spastic cerebral palsy. Neuropediatrics. 2012 Dec;43(6):307-13. doi: 10.1055/s-0032-1327774. Epub 2012 Sep 25.

  PMID: 23011753 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zubeyir Sarı

  Marmara University Institute of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Neslihan Karabacak

CONTACT

+905347474980; neslikarabacak@gmail.com

Canan Günay Yazıcı

CONTACT

+905384601249; cnngnyzc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 26, 2019
• Study Start: April 1, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share