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

March 26, 2019 updated by: Marmara University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hippotherapy is a therapeutic method in which a real horse is used for therapeutic purposes. It is widely used in many countries in the treatment of neuromuscular diseases (Multiple Sclerosis, stroke, Cerebral Palsy, etc.). Although the use of hippotherapy is widespread, many people can not reach and use this method effectively because of many reasons such as the high cost of caring, feeding, and sheltering horses or fear of people from horses. In recent years, hippotherapy simulation devices (mechanic and robotic horses) have been developed to overcome these problems. These devices aim to create the effects of hippotherapy on people by simulating a real horse's movement. The aim of this project is to develop and produce a simulated hippotherapy system, which can be controlled by electromyography (EMG) signals coming from the rider, movements programmable (for different musculoskeletal problems), rehabilitation-specific, providing evaluation during therapy, integrating virtual reality system and therapy games and investigate its effectiveness in children with cerebral palsy.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control Group
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
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.
Other Names:
  • Bobath Therapy
ACTIVE_COMPARATOR: Study Group
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: Neurodevelopmental Therapy
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.
Other Names:
  • Bobath Therapy
Other: Hippotherapy
Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional level from baseline, week 8 and week 16
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Zubeyir Sarı, Marmara University Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2019

Primary Completion (ANTICIPATED)

September 20, 2019

Study Completion (ANTICIPATED)

September 20, 2019

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (ACTUAL)

March 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2017.297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, statistical analysis plan, informed consent form, clinical study report might be considered to be shared with the clinicians studying in the same field one year after the publication of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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