Cerebral PalsyHippotherapyNCT03548376
Hippotherapy in Children With Cerebral Palsy
A study testing Hippotherapy in people with Cerebral Palsy, run by Federal University of Minas Gerais.
Trial summary
The hippotherapy is a complementary therapeutic modality that seeks to promote changes in the functionality of children with cerebral palsy (CP). Knowing the domains in which this therapy causes both direct and indirect effects, and identify the mechanisms that produce their effects, contributes to broadening and… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hippotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Feb 2018
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with medical diagnosis of cerebral palsy
- Ages 4 to 12 years old
Who cannot join
- Other CP-associated diagnoses (e.g., autism)
About this study
Official title: Effects of Hippotherapy in Postural Control, Balance, Gross-motor Function and Quality of Life of Children With Cerebral Palsy
The hippotherapy is a complementary therapeutic modality that seeks to promote changes in the functionality of children with cerebral palsy (CP). Knowing the domains in which this therapy causes both direct and indirect effects, and identify the mechanisms that produce their effects, contributes to broadening and deepening of the knowledge available on the hippotherapy. The main aim of this study was to evaluate changes in postural control and balance, gross motor function and quality of life (QoL) of children with CP undergoing hippotherapy for a period of six months.
Read the detailed description
We conducted a quasi-experimental study with 31 children with cerebral palsy from both sexes, of various types and GMFCS levels who were followed for 6 months with three repeated measurements: beginning of the study (T1), 3 months (T2) and 6 months (T3) after the initial evaluation. Participants were measured 3 times on postural control and balance, gross-motor function and twice on quality of life. Children attended hippotherapy session one a week for 30 minutes. Sessions were conducted by equestrian therapists (physiotherapists or occupational therapists) qualified by the National (Brazilian) Association of Hippotherapy. The horses were trained for hippotherapy practice, and each patient used the same animal in all sessions. The specific hippotherapy gear included safety straps, riding blankets, stirrups and saddles with and without support straps. The use of protective helmets for patients was mandatory in all sessions. Playful and educational toys were also used. The participants included the patient, the equestrian therapist, the horse handler (the professional who drives the horse) and, when necessary, an auxiliary helper to ensure the safety of the child. The hippotherapy sessions were individualized. The goals set by the therapist were based on the specific demands and the motor condition of each client. The activities proposed during each session sought to stimulate the development of the postural control of the child with CP. Such activities could be performed in various postures (i.e., classic, inverted, lateral, dorsal decubitus, ventral decubitus and standing on the stirrups). They included demands for stability and balance (i.e., trunk rotation activities, range in various directions and bimanual tasks), active stretches and antigravitational exercises during riding, integrated with ludic-cognitive resources (i.e., memory games and identification of colors, numbers and letters). For the most part, children with mild and moderate impairments rode individually and were encouraged to maintain an upright posture throughout the session. Those with more severe impairment were encouraged to maintain control and postural alignment, with the minimum of support being provided. In some cases, it was necessary to use a double riding strategy, in which the therapist rode the horse along with the patient to favor and stimulate the child's postural control on the animal. Throughout the session, the horse varied speed, cadence and direction to the therapist's command, using different paths (i.e., circles, zigzags and straight lines) and different types of terrain (i.e., uphill, downhill, dirt, asphalt and grass). All participants were instructed to continue with their rehabilitation routine (i.e., physical therapy, occupational therapy and others). For data analysis, participants were stratified by age (04-07 years and 08-12 years), severity (mild, moderate and severe), topography of the members involved (diplegia, hemiplegia, and quadriplegia) and previous time of hippotherapy (between 3-6 months and more than 6 months).
- Conditions
- Cerebral Palsy
- Being tested
- Hippotherapy
- Keywords
- rehabilitation, cerebral palsy, postural control, balance, gross-motor function, quality of life, hippotherapy
- 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
Also called horse therapy, equine movement therapy
Hippotherapy is a therapeutic intervention that is typically conducted by a physical or occupational therapist and is aimed at improving impaired body function. Hippotherapy has been proposed as a technique to decrease the energy requirements and improve walking in patients with cerebral palsy. It is thought that the natural swaying motion of the horse induces a pelvic movement in the rider that simulates human ambulation. In addition, variations in the horse's movements can also prompt natural equilibrium movements in the rider.
| Study group | Role | What they receive |
|---|---|---|
| One-group intervention | Experimental | Hippotherapy sessions were delivered once a week for 30 minutes, during 6 months. Receives: Other: Hippotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child's Postural control and balance
The Early Clinical Assessment of Balance (ECAB) estimates the postural stability of the child according to head and trunk controls during static activities and dynamic activities
Measured: From Pre-intervention to 3 months after intervention onset
Change in Child's Postural control and balance
The Early Clinical Assessment of Balance (ECAB) estimates the postural stability of the child according to head and trunk controls during static activities and dynamic activities
Measured: From 3 months to 6 months after intervention onset
Secondary outcomes (3)
Change in Child's Gross Motor Function Measure (GMFM)
Assessed by the GMFM-88, which includes five dimensions: (A) Lying and Rolling, (B) Sitting, (C) Crawling and Kneeling, (D) Standing and (E) Walking, Running and Jumping. The item scores generate a score for each dimension and a total score. Higher scores give information on a greater repertoire of the gross motor function.
Measured: From pre-intervention to 3 months after intervention onset
Change in Child's Gross Motor Function Measure (GMFM)
Assessed by the GMFM-88, which includes five dimensions: (A) Lying and Rolling, (B) Sitting, (C) Crawling and Kneeling, (D) Standing and (E) Walking, Running and Jumping. The item scores generate a score for each dimension and a total score. Higher scores give information on a greater repertoire of the gross motor function.
Measured: From 3 months to 6 months after intervention onset (end on intervention period)
Change in Child's Quality of Life
Assessed by the Quality of Life Questionnaire for Children with Cerebral Palsy: questionnaire for primary caregivers (CPQOL-Child), which gives information on the wellbeing of children with CP between 4 and 12 years of age and was administered in an interview with key caregivers. This version has 66 questions organized in seven domains of QOL: social wellbeing and acceptance; functioning; participation and physical health; emotional wellbeing and self-esteem; access to services; pain and disability impact; and family health. Scoring is transformed into domain-specific percentages.
Measured: From pre-intervention to 6 months after intervention onset (end on intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Nov 2016
- Primary completion12 Aug 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Model description
- Before-after trial (6 months of follow-up; one group with three repeated measurements)
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marisa Cotta Mancini, Federal University of Minas Gerais
- Investigators
- Marisa C Mancini, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548376
- Sponsor's protocol ID
- MMancini
- Acronym
- Hippotherapy
- Status last verified
- Jun 2018
- First submitted
- 24 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Zadnikar M, Kastrin A. Effects of hippotherapy and therapeutic horseback riding on postural control or balance in children with cerebral palsy: a meta-analysis. Dev Med Child Neurol. 2011;53: 684-691. 2. Whalen CN, Case-Smith J. Therapeutic effects if horseback riding on gross motor function in children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2012;32: 229-242. 3. Meregliano G. Hippotherapy. Phys Med Rehabil Clin North Am. 2004;15: 843-854. 4. Debuse D, Gibb C, Chandler C. Effects of hippotherapy on people with cerebral palsy from the users' perspective: a qualitative study. Phys Theor Pract. 2009;25(3): 174-192.. 5. Davis E, Davies B, Wolfe R, Raadsveld R, Heine B, Thomason P, et al. A randomized controlled trial of the impact of therapeutic horse riding on the quality of life, health, and function of children with cerebral palsy. Dev Med Child Neurol. 2009;51: 111-119. 6. McCoy SW, Bartlett DJ, Yocum A, Jeffries L, Fiss AL, Chiarello L, et al. Development and validity of the early assessment of balance for young children with cerebral palsy. Dev Neurorehabil. 2014; 17: 375-383. 7. Randall KE, Bartlett DK, McCoy SW. Measuring postural stability in young children with cerebral palsy: a comparison of 2 instruments. Pediatr Phys Ther, 2014;26: 332-337. 8. Cyrillo LT, Galvão MCS. Gross Motor Function Measure [GMFM-66 & GMFM-88] (Portuguese translated manual). São Paulo: Memnon; 2011. 9. Russel DJ, Rosenbaum PL, Cadman DT, Gowland C, Hardy S, Jarvis S. The gross motor function measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol. 1989; 31: 341-352. 10. Russel DJ, Avery LM, Rosenbaum PL, Raina, PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Physical Therapy, 2000;80: 873-885. 11. Waters E, Maher E, Salmon L, Reddihpugh D, Boyd R. Developing a new quality of life scale for children with cerebral palsy. Child: Care, Health and Develop. 2005; 31: 127-135. 12. Braccialli LMP, Braccialli AC, Sankako AN, Dechandt MLC, Almeida VC, Carvalho SMR. Quality of life questionnaire for children with cerebral palsy (CP QOL-CHILD): Translation and cultural adaptation to the Brazilian Portuguese language. J Hum Growth and Develop. 2013; 23(2): 154-163. 13. Shurtleff TL, Standeven JW, Engsberg JR. Changes in dynamic trunk/head stability and functional reach after hippotherapy. Arch Phys Med Rehabil. 2009;90: 1185-1195. 14. Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004;16: 165-172. 15. Park 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;55(6): 1736-1742. 16. Hammil D, Washington K, White OR. The effect of hippotherapy on postural control in sitting for children with cerebral palsy. Phys Occup Ther Pediatr. 2007;27: 23-42. 17. Galloux P, Richard N, Dronka T, Leard M, Perrot A, Jouffroy JL, et al. Analysis of equine gait using three-dimensional accelerometers fixed on the saddle. Equine Vet J. 1994; 17(Suppl.): 44-47. 18. Temcharoensuk P, Lekskulchai R, Akamanon C, Ritruechai P, Sutcharitpongsa S. Effect of horseback riding simulator on sitting ability of children with cerebral palsy: a randomized controlled trial. J Phys Ther Sci. 2015;27: 273-277.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hippotherapy in Postural Control, Balance, Gross-motor Function and Quality of Life of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03548376
- Acronym / sponsor ID
- Hippotherapy / MMancini
- Conditions
- Cerebral Palsy
- Keywords
- rehabilitation, cerebral palsy, postural control, balance, gross-motor function, quality of life, hippotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Jun 2018 (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 hippotherapy is a complementary therapeutic modality that seeks to promote changes in the functionality of children with cerebral palsy (CP). Knowing the domains in which this therapy causes both direct and indirect effects, and identify the mechanisms that produce their effects, contributes to broadening and deepening of the knowledge available on the hippotherapy. The main aim of this study was to evaluate changes in postural control and balance, gross motor function and quality of life (QoL) of children with CP undergoing hippotherapy for a period of six months.
Detailed description
We conducted a quasi-experimental study with 31 children with cerebral palsy from both sexes, of various types and GMFCS levels who were followed for 6 months with three repeated measurements: beginning of the study (T1), 3 months (T2) and 6 months (T3) after the initial evaluation. Participants were measured 3 times on postural control and balance, gross-motor function and twice on quality of life. Children attended hippotherapy session one a week for 30 minutes. Sessions were conducted by equestrian therapists (physiotherapists or occupational therapists) qualified by the National (Brazilian) Association of Hippotherapy. The horses were trained for hippotherapy practice, and each patient used the same animal in all sessions. The specific hippotherapy gear included safety straps, riding blankets, stirrups and saddles with and without support straps. The use of protective helmets for patients was mandatory in all sessions. Playful and educational toys were also used. The participants included the patient, the equestrian therapist, the horse handler (the professional who drives the horse) and, when necessary, an auxiliary helper to ensure the safety of the child. The hippotherapy sessions were individualized. The goals set by the therapist were based on the specific demands and the motor condition of each client. The activities proposed during each session sought to stimulate the development of the postural control of the child with CP. Such activities could be performed in various postures (i.e., classic, inverted, lateral, dorsal decubitus, ventral decubitus and standing on the stirrups). They included demands for stability and balance (i.e., trunk rotation activities, range in various directions and bimanual tasks), active stretches and antigravitational exercises during riding, integrated with ludic-cognitive resources (i.e., memory games and identification of colors, numbers and letters). For the most part, children with mild and moderate impairments rode individually and were encouraged to maintain an upright posture throughout the session. Those with more severe impairment were encouraged to maintain control and postural alignment, with the minimum of support being provided. In some cases, it was necessary to use a double riding strategy, in which the therapist rode the horse along with the patient to favor and stimulate the child's postural control on the animal. Throughout the session, the horse varied speed, cadence and direction to the therapist's command, using different paths (i.e., circles, zigzags and straight lines) and different types of terrain (i.e., uphill, downhill, dirt, asphalt and grass). All participants were instructed to continue with their rehabilitation routine (i.e., physical therapy, occupational therapy and others). For data analysis, participants were stratified by age (04-07 years and 08-12 years), severity (mild, moderate and severe), topography of the members involved (diplegia, hemiplegia, and quadriplegia) and previous time of hippotherapy (between 3-6 months and more than 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-after trial (6 months of follow-up; one group with three repeated measurements)
| Arm | Type | Receives |
|---|---|---|
| One-group intervention | Experimental | Other: HippotherapyHippotherapy sessions were delivered once a week for 30 minutes, during 6 months. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with medical diagnosis of cerebral palsy
- Ages 4 to 12 years old
Key exclusion criteria (1 listed)
- Other CP-associated diagnoses (e.g., autism)
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 |
|---|---|---|
| HippotherapyAlso: horse therapy, equine movement therapyHippotherapy is a therapeutic intervention that is typically conducted by a physical or occupational therapist and is aimed at improving impaired body function. Hippotherapy has been proposed as a technique to decrease the energy requirements and improve walking in patients with cerebral palsy. It is thought that the natural swaying motion of the horse induces a pelvic movement in the rider that simulates human ambulation. In addition, variations in the horse's movements can also prompt natural equilibrium movements in the rider. | Other | One-group intervention |
Primary outcome
Change in Child's Postural control and balance
Time frame: From Pre-intervention to 3 months after intervention onset
The Early Clinical Assessment of Balance (ECAB) estimates the postural stability of the child according to head and trunk controls during static activities and dynamic activities
Change in Child's Postural control and balance
Time frame: From 3 months to 6 months after intervention onset
The Early Clinical Assessment of Balance (ECAB) estimates the postural stability of the child according to head and trunk controls during static activities and dynamic activities
3 secondary outcomes
Change in Child's Gross Motor Function Measure (GMFM)
Time frame: From pre-intervention to 3 months after intervention onset
Change in Child's Gross Motor Function Measure (GMFM)
Time frame: From 3 months to 6 months after intervention onset (end on intervention period)
Change in Child's Quality of Life
Time frame: From pre-intervention to 6 months after intervention onset (end on intervention period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Results publication1. Zadnikar M, Kastrin A. Effects of hippotherapy and therapeutic horseback riding on postural control or balance in children with cerebral palsy: a meta-analysis. Dev Med Child Neurol. 2011;53: 684-691. 2. Whalen CN, Case-Smith J. Therapeutic effects if horseback riding on gross motor function in children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2012;32: 229-242. 3. Meregliano G. Hippotherapy. Phys Med Rehabil Clin North Am. 2004;15: 843-854. 4. Debuse D, Gibb C, Chandler C. Effects of hippotherapy on people with cerebral palsy from the users' perspective: a qualitative study. Phys Theor Pract. 2009;25(3): 174-192.. 5. Davis E, Davies B, Wolfe R, Raadsveld R, Heine B, Thomason P, et al. A randomized controlled trial of the impact of therapeutic horse riding on the quality of life, health, and function of children with cerebral palsy. Dev Med Child Neurol. 2009;51: 111-119. 6. McCoy SW, Bartlett DJ, Yocum A, Jeffries L, Fiss AL, Chiarello L, et al. Development and validity of the early assessment of balance for young children with cerebral palsy. Dev Neurorehabil. 2014; 17: 375-383. 7. Randall KE, Bartlett DK, McCoy SW. Measuring postural stability in young children with cerebral palsy: a comparison of 2 instruments. Pediatr Phys Ther, 2014;26: 332-337. 8. Cyrillo LT, Galvão MCS. Gross Motor Function Measure [GMFM-66 & GMFM-88] (Portuguese translated manual). São Paulo: Memnon; 2011. 9. Russel DJ, Rosenbaum PL, Cadman DT, Gowland C, Hardy S, Jarvis S. The gross motor function measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol. 1989; 31: 341-352. 10. Russel DJ, Avery LM, Rosenbaum PL, Raina, PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Physical Therapy, 2000;80: 873-885. 11. Waters E, Maher E, Salmon L, Reddihpugh D, Boyd R. Developing a new quality of life scale for children with cerebral palsy. Child: Care, Health and Develop. 2005; 31: 127-135. 12. Braccialli LMP, Braccialli AC, Sankako AN, Dechandt MLC, Almeida VC, Carvalho SMR. Quality of life questionnaire for children with cerebral palsy (CP QOL-CHILD): Translation and cultural adaptation to the Brazilian Portuguese language. J Hum Growth and Develop. 2013; 23(2): 154-163. 13. Shurtleff TL, Standeven JW, Engsberg JR. Changes in dynamic trunk/head stability and functional reach after hippotherapy. Arch Phys Med Rehabil. 2009;90: 1185-1195. 14. Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004;16: 165-172. 15. Park 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;55(6): 1736-1742. 16. Hammil D, Washington K, White OR. The effect of hippotherapy on postural control in sitting for children with cerebral palsy. Phys Occup Ther Pediatr. 2007;27: 23-42. 17. Galloux P, Richard N, Dronka T, Leard M, Perrot A, Jouffroy JL, et al. Analysis of equine gait using three-dimensional accelerometers fixed on the saddle. Equine Vet J. 1994; 17(Suppl.): 44-47. 18. Temcharoensuk P, Lekskulchai R, Akamanon C, Ritruechai P, Sutcharitpongsa S. Effect of horseback riding simulator on sitting ability of children with cerebral palsy: a randomized controlled trial. J Phys Ther Sci. 2015;27: 273-277.
- 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.
Marisa C Mancini, PhD principal investigator
Federal University of Minas Gerais
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy in people with Cerebral Palsy, run by Federal University of Minas Gerais.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child's Postural control and balance (time frame: From Pre-intervention to 3 months after intervention onset). 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 NCT03548376, which also lists 1 linked publication.
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 7 Jun 2018.