Cerebral PalsyNCT03889262
Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
A study testing Hippotherapy and Neurodevelopmental Therapy in people with Cerebral Palsy, run by Marmara University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hippotherapy and Neurodevelopmental Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Hippotherapy, Neurodevelopmental Therapy
- Keywords
- Cerebral Palsy, Physiotherapy and Rehabilitation, Hippotherapy, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes.
Neurodevelopmental TherapyOther
Also called Bobath 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hippotherapy; Other: Neurodevelopmental Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion20 Sep 2019 (estimated)
- Study completion20 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zubeyir Sarı, Study director, Marmara University Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889262
- Sponsor's protocol ID
- 09.2017.297
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26930110Han 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.
PubMed 23342307Herrero 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.
PubMed 22610128Hosaka 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.
PubMed 20942267Glanzman 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.
PubMed 19011528Franjoine 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.
PubMed 17057441Kim 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.
PubMed 25465508Kim 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.
PubMed 28533611Kucukdeveci 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.
PubMed 11386402Lee 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.
PubMed 24707098Lee 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.
PubMed 21876292Lee 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.
PubMed 28533630Leveille 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.
PubMed 28379061Mutlu A, Livanelioglu A, Gunel MK. Reliability of goniometric measurements in children with spastic cerebral palsy. Med Sci Monit. 2007 Jul;13(7):CR323-9.
PubMed 17599027Mutlu 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.
PubMed 18402701
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03889262
- Acronym / sponsor ID
- 09.2017.297
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Physiotherapy and Rehabilitation, Hippotherapy, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 20 Sep 2019 (estimated)
- Study completion
- 20 Sep 2019 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Neurodevelopmental TherapyParticipants 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. |
| Study Group | Active comparator | Other: Hippotherapy, Other: Neurodevelopmental TherapyAfter 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (8 listed)
- Having hip dislocation,
- Severe contracture or deformity,
- Scoliosis (above 20 degrees),
- Acute uncontrolled acute seizures,
- Epilepsy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HippotherapyHippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes. | Other | Study Group |
| Neurodevelopmental TherapyAlso: Bobath TherapyNeurodevelopmental 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 | Control Group, Study Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 26930110Champagne 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.
- Background: PubMed 23342307Han 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.
- Background: PubMed 22610128Herrero 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.
- Background: PubMed 20942267Hosaka 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.
- Background: PubMed 19011528Glanzman 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.
- Background: PubMed 17057441Franjoine 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.
- Background: PubMed 25465508Kim 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.
- Background: PubMed 28533611Kim 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.
- Background: PubMed 11386402Kucukdeveci 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.
- Background: PubMed 24707098Lee 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.
- Background: PubMed 21876292Lee 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.
- Background: PubMed 28533630Lee 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zubeyir Sarı study director
Marmara University Institute of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy and Neurodevelopmental Therapy in people with Cerebral Palsy, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neslihan Karabacak (+905347474980, neslikarabacak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional level from baseline, week 8 and week 16 (time frame: 16 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889262, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.