NCT04885023

Brief Summary

This study showed that the addition of hippotherapy to Schroth exercises is more effective in improving postural asymmetry and balance ability in adolescents with idiopathic scoliosis compared to Schroth exercises alone. Therefore, this combination should be considered during designing a rehabilitation program for AIS

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

May 4, 2021

Last Update Submit

May 9, 2021

Conditions

Keywords

HipptherapyFormatericBalanceSchroth exercises

Outcome Measures

Primary Outcomes (5)

  • Scoliotic angle un degrees

    Measured by formatric 4-D system

    10 weeks

  • Kyphotic angle in degrees

    Measured by formatric 4-D system

    10 weeks

  • Pelvic obliquity in degrees

    Measured by formatric 4-D system

    10 weeks

  • Pelvic torsion in degrees

    Measured by formatric 4-D system

    10 weeks

  • Vertical spinal rotation in degrees

    Measured by formatric 4-D system

    10 weeks

Secondary Outcomes (3)

  • Overall balance index

    10 weeks

  • Anteroposterior balance index

    10 weeks

  • Mediolateral balance index

    10 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Twenty six patients who received hippotherapy combined with Schroth exercises for ten weeks

Other: Hippotherapy

Control group

OTHER

Twenty six patients who received only Schroth exercises for ten weeks

Other: Hippotherapy

Interventions

The hippotherapy program for 10 weeks

Also known as: Schroth exercises
Control groupStudy group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • AIS,
  • all curve types,
  • curves with Cobb angle ranged between 10 and 25 degrees,
  • a Risser grade 0 to 5, and
  • the ability to attend weekly visits.

You may not qualify if:

  • Children with any significant history of riding horses,
  • with diagnosis other than AIS,
  • having other treatment which might affect scoliosis,
  • having chronic diseases requiring any drug usage,
  • presence of other neurologic, muscular or rheumatic diseases, and
  • having non-idiopathic scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batterjee Medical College

Jeddah, Mecca Region, 21442, Saudi Arabia

Location

MeSH Terms

Interventions

Equine-Assisted Therapy

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Amr A AbdelAziem, Ph.D

    Tyiaf University, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
All participants in two groups in addition to the formetric measurements and Biodex body balance assessors were not aware of the purpose of the study
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A total of 52 patients (15 males and 37 females) participated in the current study, assigned to 2 groups, which were the group A who received hippotherapy combined with Schroth exercises and group B who received only Schroth exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 13, 2021

Study Start

February 20, 2020

Primary Completion

December 18, 2020

Study Completion

March 7, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Data Will Be available only for third parties

Locations