NCT03212846

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

July 7, 2017

Last Update Submit

July 9, 2017

Conditions

Keywords

hippotherapycerebral palsyspasticity

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

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.

Other: Hippotherapy

Control group

NO INTERVENTION

Children will receive the conventional treatment, based on physiotherapy related techniques, such as neurodevelopmental treatment (twice a week).

Interventions

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.

Treatment group

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Primor diagnosis of spastic cerebral palsy
  • Children aged 3-14

You may not qualify if:

  • Children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing and Physiotherapy

Cadiz, 11009, Spain

Location

Related Publications (7)

  • 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.

    PMID: 17057544BACKGROUND
  • McGibbon 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.

    PMID: 9881805BACKGROUND
  • Whalen 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.

    PMID: 22122355BACKGROUND
  • Sterba 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.

  • 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 Aug;53(8):684-91. doi: 10.1111/j.1469-8749.2011.03951.x. Epub 2011 Mar 24.

  • Kwon 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.

  • McGibbon 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.

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Radomized controlled trial with two groups: intervention group (hippotherapy + conventional treatment) and control group (conventional treatment).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Clinical Professor

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 12, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

No provided.

Locations