Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
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| ClinicalTrials.gov Identifier: NCT03889262 |
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Recruitment Status : Unknown
Verified March 2019 by Marmara University.
Recruitment status was: Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 28, 2019
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Sponsor:
Marmara University
Information provided by (Responsible Party):
Marmara University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Other: Hippotherapy Other: Neurodevelopmental Therapy | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy |
| Estimated Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | September 20, 2019 |
| Estimated Study Completion Date : | September 20, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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 Name: Bobath Therapy |
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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.
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Other: Hippotherapy
Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes. 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 Name: Bobath Therapy |
Primary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889262
Contacts
| Contact: Neslihan Karabacak | +905347474980 | neslikarabacak@gmail.com | |
| Contact: Canan Günay Yazıcı | +905384601249 | cnngnyzc@gmail.com |
Sponsors and Collaborators
Marmara University
Investigators
| Study Director: | Zubeyir Sarı | Marmara University Institute of Health Sciences |
Study Documents (Full-Text)
Documents provided by Marmara University:
Documents provided by Marmara University:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form [PDF] February 28, 2019
Publications:
| Responsible Party: | Marmara University |
| ClinicalTrials.gov Identifier: | NCT03889262 |
| Other Study ID Numbers: |
09.2017.297 |
| First Posted: | March 26, 2019 Key Record Dates |
| Last Update Posted: | March 28, 2019 |
| Last Verified: | March 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Marmara University:
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Cerebral Palsy Physiotherapy and Rehabilitation Hippotherapy Balance |
Additional relevant MeSH terms:
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Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases |
Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |