Cerebral PalsyNCT06550258
Effects of Hippotherapy on Functionality in Children With Cerebral Palsy
A study testing Equine-assisted therapy and Traditional Pediatric Physiotherapy in people with Cerebral Palsy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical review is to investigate the effect of hippotherapy in improving upper limb functionality in children with cerebral palsy. The main question it aims to answer is The questions are as follows: 1. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Equine-assisted therapy and Traditional Pediatric Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to Oct 2024
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having been diagnosed with SP
- Being between the ages of 4-16
- Being at GMFCS (Gross Motor Function Classification System) level 1,2 or 3
- Being at MACS (The Manual Ability Classification System) level 1,2,3 or 4
- Having a stable clinical condition
- Having the cognitive level to follow the instructions in the test and treatment protocol
Who cannot join
- Families who do not sign the consent form
- Presence of active seizures
- Presence of developmental hip dysplasia
- Presence of allergy to horses
- Having undergone surgical intervention or Botulinum Toxin A (BTX-A) application in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University
Istanbul, Ümraniye, 34768
Tuba Kolaylı, MSc., tuba.kolayli@uskudar.tr
About this study
Official title: Effects of Hippotherapy on Upper Extremity Functionality and Trunk Control in Children With Cerebral Palsy
The purpose of this clinical review is to investigate the effect of hippotherapy in improving upper limb functionality in children with cerebral palsy. The main question it aims to answer is The questions are as follows:
- Does hippotherapy improve gross motor function of the upper extremity in children with cerebral palsy?
- Is the development of trunk control in children with cerebral palsy who receive hippotherapy different from the development of trunk control in children who receive conventional physiotherapy?
Participants will:
Hippotherapy and routine physiotherapy in 2 different groups for 2 They will carry out the necessary evaluations before the implementation and at the end of 2 months.
Read the detailed description
Cerebral palsy (CP) is a permanent developmental disorder that occurs as a result of a lesion in the developing baby's brain. Due to the symptoms seen in CP, the individual's participation in daily living activities (ADL) is restricted and functional mobility is affected. Hippotherapy is preferred in children with CP because it includes fun activities and is effective in terms of the child's participation and motivation. The aim of this study is to examine the effect of hippotherapy on upper extremity function. In this study planned as a multicenter study, children with CP are divided into 2 groups as the study and control groups. After a 2-month application, children with CP will be evaluated in terms of upper extremity functionality and postural control. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p<0.05).
- Conditions
- Cerebral Palsy
- Being tested
- Equine-assisted therapy, Traditional Pediatric Physiotherapy
- Keywords
- hippotherapy, physiotherapy, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine-assisted therapyOther
Hippotherapy is a therapeutic intervention applied by physiotherapists that aims to improve impaired body functions. Hippotherapy is a therapy in which the rider receives stimuli from the horse that stimulate the sensory, neuromotor and cognitive systems during riding and exercise on the back of a horse. Hippotherapy is effective on posture control, balance, gross motor functions and functional performance in children with cerebral palsy.
Traditional Pediatric PhysiotherapyOther
In traditional pediatric physiotherapy, cushions of appropriate hardness were used for proprioceptive input. Stools of different heights were used for sitting, squatting, standing up by holding on and standing, Bobath balls and balance boards were used for balance reactions. Triangular and roll cushions of different hardness were used for weight transfer. Surfaces with different patterns were used for sensory input. The child's wishes and interests were taken into consideration in the selection of materials. The treatment was planned according to the activities that were difficult in daily life and the aim was to transfer the knowledge learned to daily life.
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy group | Experimental | Hippotherapy was applied with a physiotherapist for 2 months. Receives: Other: Equine-assisted therapy |
| Control group | Active comparator | Classical physiotherapy was applied with the help of a physiotherapist for 2 months. Receives: Other: Traditional Pediatric Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and block test
This test evaluates manual dexterity. The person being tested is asked to move blocks from one compartment to the other compartment as fast as they can within 60 seconds. The test is started with the dominant hand and the test is repeated with both hands. In addition, a 15-second trial period is given for both hands. The blocks are held in the compartment on the side of the hand to be tested, and the test is started by positioning the box in the midline of the person being tested. When the time is up, the blocks carried are counted and the result is recorded.
Measured: 8 weeks
Trunk Control Measurement Scale
The Trunk Control Measurement Scale includes 15 items that measure the two main components of trunk control, static and dynamic sitting balance. The Static Sitting Balance Scale (items 1-5) evaluates the ability to maintain stable trunk posture during movements of the upper and lower extremities. The Dynamic Sitting Balance Scale (items 6-15) is divided into two subscales: the selective movement control scale and the dynamic reach scale. The total score ranges from 0-58. A high score indicates good performance.
Measured: 8 weeks
Secondary outcomes (3)
ABILHAND-Kids
It is used to measure hand functions in children with CP. It aims to measure the use of the upper extremity in children's daily activities in 21 items (It is examined in 3 columns as cannot be done, difficult, easy. It mostly evaluates the function of both hands together. The scale is generally applied by asking the families, if the child is older, he/she can be included in the application. There should be no assistive device or human support while evaluating the functional ability.
Measured: 8 weeks
Moberg pickup test
In a performance-based (timed) manual dexterity test, the patient is asked to fill certain items into a box. The test is started with the dominant hand, then with the non-dominant hand and with eyes closed. The test is repeated 3 times and the best time on the stopwatch is noted.
Measured: 8 weeks
Gross Motor Function Measure
GMFM-88 is a scale developed for children with CP to show changes in gross motor functions. It is divided into 5 main sections as lying-rolling, sitting, crawling-kneeling, standing, walking-running-jumping. The values are divided into 4 categories as -Cannot initiate the activity ''0'', -Initiates independently ''1'', -Partially completes ''2'', -Completes independently ''3''. The total score is calculated as a percentage, as the percentage values increase, motor functions increase.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Aug 2024
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Before - after trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba kolaylı, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550258
- Sponsor's protocol ID
- 61351342/2019-399
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26930110Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014 Nov;55(6):1736-42. doi: 10.3349/ymj.2014.55.6.1736.
PubMed 25323914Kwon JY, Chang HJ, Yi SH, Lee JY, Shin HY, Kim YH. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial. J Altern Complement Med. 2015 Jan;21(1):15-21. doi: 10.1089/acm.2014.0021. Epub 2014 Dec 31.
PubMed 25551626
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hippotherapy on Upper Extremity Functionality and Trunk Control in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06550258
- Acronym / sponsor ID
- 61351342/2019-399
- Conditions
- Cerebral Palsy
- Keywords
- hippotherapy, physiotherapy, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Aug 2024 (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 clinical review is to investigate the effect of hippotherapy in improving upper limb functionality in children with cerebral palsy. The main question it aims to answer is The questions are as follows:
- Does hippotherapy improve gross motor function of the upper extremity in children with cerebral palsy?
- Is the development of trunk control in children with cerebral palsy who receive hippotherapy different from the development of trunk control in children who receive conventional physiotherapy?
Participants will:
Hippotherapy and routine physiotherapy in 2 different groups for 2 They will carry out the necessary evaluations before the implementation and at the end of 2 months.
Detailed description
Cerebral palsy (CP) is a permanent developmental disorder that occurs as a result of a lesion in the developing baby's brain. Due to the symptoms seen in CP, the individual's participation in daily living activities (ADL) is restricted and functional mobility is affected. Hippotherapy is preferred in children with CP because it includes fun activities and is effective in terms of the child's participation and motivation. The aim of this study is to examine the effect of hippotherapy on upper extremity function. In this study planned as a multicenter study, children with CP are divided into 2 groups as the study and control groups. After a 2-month application, children with CP will be evaluated in terms of upper extremity functionality and postural control. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Before - after trial
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy group | Experimental | Other: Equine-assisted therapyHippotherapy was applied with a physiotherapist for 2 months. |
| Control group | Active comparator | Other: Traditional Pediatric PhysiotherapyClassical physiotherapy was applied with the help of a physiotherapist for 2 months. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Having been diagnosed with SP
- Being between the ages of 4-16
- Being at GMFCS (Gross Motor Function Classification System) level 1,2 or 3
- Being at MACS (The Manual Ability Classification System) level 1,2,3 or 4
- Having a stable clinical condition
Key exclusion criteria (5 listed)
- Families who do not sign the consent form
- Presence of active seizures
- Presence of developmental hip dysplasia
- Presence of allergy to horses
- Having undergone surgical intervention or Botulinum Toxin A (BTX-A) application in the last 6 months
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 |
|---|---|---|
| Equine-assisted therapyHippotherapy is a therapeutic intervention applied by physiotherapists that aims to improve impaired body functions. Hippotherapy is a therapy in which the rider receives stimuli from the horse that stimulate the sensory, neuromotor and cognitive systems during riding and exercise on the back of a horse. Hippotherapy is effective on posture control, balance, gross motor functions and functional performance in children with cerebral palsy. | Other | Hippotherapy group |
| Traditional Pediatric PhysiotherapyIn traditional pediatric physiotherapy, cushions of appropriate hardness were used for proprioceptive input. Stools of different heights were used for sitting, squatting, standing up by holding on and standing, Bobath balls and balance boards were used for balance reactions. Triangular and roll cushions of different hardness were used for weight transfer. Surfaces with different patterns were used for sensory input. The child's wishes and interests were taken into consideration in the selection of materials. The treatment was planned according to the activities that were difficult in daily life and the aim was to transfer the knowledge learned to daily life. | Other | Control group |
Primary outcome
Box and block test
Time frame: 8 weeks
This test evaluates manual dexterity. The person being tested is asked to move blocks from one compartment to the other compartment as fast as they can within 60 seconds. The test is started with the dominant hand and the test is repeated with both hands. In addition, a 15-second trial period is given for both hands. The blocks are held in the compartment on the side of the hand to be tested, and the test is started by positioning the box in the midline of the person being tested. When the time is up, the blocks carried are counted and the result is recorded.
Trunk Control Measurement Scale
Time frame: 8 weeks
The Trunk Control Measurement Scale includes 15 items that measure the two main components of trunk control, static and dynamic sitting balance. The Static Sitting Balance Scale (items 1-5) evaluates the ability to maintain stable trunk posture during movements of the upper and lower extremities. The Dynamic Sitting Balance Scale (items 6-15) is divided into two subscales: the selective movement control scale and the dynamic reach scale. The total score ranges from 0-58. A high score indicates good performance.
3 secondary outcomes
ABILHAND-Kids
Time frame: 8 weeks
Moberg pickup test
Time frame: 8 weeks
Gross Motor Function Measure
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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 25323914Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014 Nov;55(6):1736-42. doi: 10.3349/ymj.2014.55.6.1736.
- Background: PubMed 25551626Kwon JY, Chang HJ, Yi SH, Lee JY, Shin HY, Kim YH. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial. J Altern Complement Med. 2015 Jan;21(1):15-21. doi: 10.1089/acm.2014.0021. Epub 2014 Dec 31.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine-assisted therapy and Traditional Pediatric Physiotherapy in people with Cerebral Palsy, run by Uskudar University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tuba Kolaylı, Mac. ((216) 400 22 22, tuba.kolayli@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and block test (time frame: 8 weeks). The study lists 2 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 NCT06550258, which also lists 3 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 13 Aug 2024.