Neuromuscular Diseases in ChildrenNCT03212846
Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy
A study testing Hippotherapy in people with Neuromuscular Diseases in Children and Cerebral Palsy, Spastic, run by University of Cadiz at 1 site in Spain.
Trial summary
The aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in addition to traditional treatment. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Neuromuscular Diseases in Children, Cerebral Palsy, Spastic, Spasticity, Muscle
- What is being tested?
- Hippotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Oct 2016
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primor diagnosis of spastic cerebral palsy
- Children aged 3-14
Who cannot join
- Children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy: a Randomized Controlled Trial
The aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in addition to traditional treatment.
Read the detailed description
The main aim of the present study is to determine the effects of hippotherapy on the hip aductors spasticity in children with spastic cerebral palsy. Furthermore, as a secondary objective is to evaluate the changes in Modified Ashworth Scale (MAS) after intervention in children ages 3-14.
- Being tested
- Hippotherapy
- Keywords
- hippotherapy, cerebral palsy, spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Children will receive the hippotherapy treatment, based on horse walking in a regular way led by an experienced leader. Sessions will be performed for 45 minutes once weekly for 12 consecutive weeks in an indoor riding area.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Children will receive hippotherapy by a licensed physical therapist. Before riding, stretching and warming exercises of the adductor muscles will be performed. Later, the patient will be seated astride with the therapist behind. In any case, the participant had no control of the horse. Therapist will be responsible for correctly positioning the subject on the horse, but no position changes or active intervention of the subject with the therapist will be made. This positioning consists on achieving the optimal body alignment with neutral pelvis. Receives: Other: Hippotherapy |
| Control group | No intervention | Children will receive the conventional treatment, based on physiotherapy related techniques, such as neurodevelopmental treatment (twice a week). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
The aim of the scale is to assess muscle tone by the joint range of motion, manually evaluated, and clinically recording passive movements' resistance. Each participant will be examined lying supine on a couch in a relaxed position. The MAS scale is, undoubtedly, the most widely used measure for the quantification of muscular hypertonia. The trunk and the head will be maintained in a neutral position to avoid eliciting tonic neck reflexes, and the passive speed movements will be made in the course of one second. It will be performed in left and right hip, independently, 5 to 8 times to obtain a more reliable result. This modified version adds a 1+ scoring category, in order to register resistance in less than half of the range of motion. Thus, the scores range is from 0 to 4, with 6 choices.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Diseases in ChildrenStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Radomized controlled trial with two groups: intervention group (hippotherapy + conventional treatment) and control group (conventional treatment).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Manuel Lucena Anton, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212846
- Sponsor's protocol ID
- CTS671
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No provided.
Publications
Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004 Fall;16(3):165-72. doi: 10.1097/01.PEP.0000136003.15233.0C.
PubMed 17057544McGibbon NH, Andrade CK, Widener G, Cintas HL. Effect of an equine-movement therapy program on gait, energy expenditure, and motor function in children with spastic cerebral palsy: a pilot study. Dev Med Child Neurol. 1998 Nov;40(11):754-62. doi: 10.1111/j.1469-8749.1998.tb12344.x.
PubMed 9881805Whalen CN, Case-Smith J. Therapeutic effects of horseback riding therapy on gross motor function in children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2012 Aug;32(3):229-42. doi: 10.3109/01942638.2011.619251. Epub 2011 Nov 29.
PubMed 22122355Sterba JA. Does horseback riding therapy or therapist-directed hippotherapy rehabilitate children with cerebral palsy? Dev Med Child Neurol. 2007 Jan;49(1):68-73. doi: 10.1017/s0012162207000175.x.
PubMed 17209981Zadnikar 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 Aug;53(8):684-91. doi: 10.1111/j.1469-8749.2011.03951.x. Epub 2011 Mar 24.
PubMed 21729249Kwon JY, Chang HJ, Lee JY, Ha Y, Lee PK, Kim YH. Effects of hippotherapy on gait parameters in children with bilateral spastic cerebral palsy. Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031.
PubMed 21530725McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: 10.1016/j.apmr.2009.01.011.
PubMed 19480872
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03212846
- Acronym / sponsor ID
- CTS671
- Keywords
- hippotherapy, cerebral palsy, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jul 2017 (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 aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in addition to traditional treatment.
Detailed description
The main aim of the present study is to determine the effects of hippotherapy on the hip aductors spasticity in children with spastic cerebral palsy. Furthermore, as a secondary objective is to evaluate the changes in Modified Ashworth Scale (MAS) after intervention in children ages 3-14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Radomized controlled trial with two groups: intervention group (hippotherapy + conventional treatment) and control group (conventional treatment).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: HippotherapyChildren will receive hippotherapy by a licensed physical therapist. Before riding, stretching and warming exercises of the adductor muscles will be performed. Later, the patient will be seated astride with the therapist behind. In any case, the participant had no control of the horse. Therapist will be responsible for correctly positioning the subject on the horse, but no position changes or active intervention of the subject with the therapist will be made. This positioning consists on achieving the optimal body alignment with neutral pelvis. |
| Control group | No intervention | –Children will receive the conventional treatment, based on physiotherapy related techniques, such as neurodevelopmental treatment (twice a week). |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primor diagnosis of spastic cerebral palsy
- Children aged 3-14
Key exclusion criteria (1 listed)
- Children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.
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 |
|---|---|---|
| HippotherapyChildren will receive the hippotherapy treatment, based on horse walking in a regular way led by an experienced leader. Sessions will be performed for 45 minutes once weekly for 12 consecutive weeks in an indoor riding area. | Other | Treatment group |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: 12 weeks
The aim of the scale is to assess muscle tone by the joint range of motion, manually evaluated, and clinically recording passive movements' resistance. Each participant will be examined lying supine on a couch in a relaxed position. The MAS scale is, undoubtedly, the most widely used measure for the quantification of muscular hypertonia. The trunk and the head will be maintained in a neutral position to avoid eliciting tonic neck reflexes, and the passive speed movements will be made in the course of one second. It will be performed in left and right hip, independently, 5 to 8 times to obtain a more reliable result. This modified version adds a 1+ scoring category, in order to register resistance in less than half of the range of motion. Thus, the scores range is from 0 to 4, with 6 choices.
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 12 Jul 2017.
- Background: PubMed 17057544Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004 Fall;16(3):165-72. doi: 10.1097/01.PEP.0000136003.15233.0C.
- Background: PubMed 9881805McGibbon NH, Andrade CK, Widener G, Cintas HL. Effect of an equine-movement therapy program on gait, energy expenditure, and motor function in children with spastic cerebral palsy: a pilot study. Dev Med Child Neurol. 1998 Nov;40(11):754-62. doi: 10.1111/j.1469-8749.1998.tb12344.x.
- Background: PubMed 22122355Whalen CN, Case-Smith J. Therapeutic effects of horseback riding therapy on gross motor function in children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2012 Aug;32(3):229-42. doi: 10.3109/01942638.2011.619251. Epub 2011 Nov 29.
- Results publication: PubMed 17209981Sterba JA. Does horseback riding therapy or therapist-directed hippotherapy rehabilitate children with cerebral palsy? Dev Med Child Neurol. 2007 Jan;49(1):68-73. doi: 10.1017/s0012162207000175.x.
- Results publication: PubMed 21729249Zadnikar 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 Aug;53(8):684-91. doi: 10.1111/j.1469-8749.2011.03951.x. Epub 2011 Mar 24.
- Results publication: PubMed 21530725Kwon JY, Chang HJ, Lee JY, Ha Y, Lee PK, Kim YH. Effects of hippotherapy on gait parameters in children with bilateral spastic cerebral palsy. Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031.
- Results publication: PubMed 19480872McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: 10.1016/j.apmr.2009.01.011.
- Individual participant dataSharing planned: No. No provided.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy in people with Neuromuscular Diseases in Children and Cerebral Palsy, Spastic, run by University of Cadiz at 1 site in Spain.
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 12 Jul 2017. 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 Spain. 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?
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?
Modified Ashworth Scale (MAS) (time frame: 12 weeks). 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 NCT03212846, which also lists 7 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 12 Jul 2017.