NCT04833868

Brief Summary

BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that negatively impacts the respiratory system and physical conditioning in adolescents. Hippotherapy is an equestrian intervention that optimizes physical performance and mobility in a bunch of contexts; however, its influence on pulmonary function remains unclear. AIM: This research aimed to analyze the impact of ten weeks of hippotherapy combined with Schroth exercises on ventilatory function and aerobic capacity in AIS. DESIGN: Randomized Controlled Trial SETTING: Outpatients attend a single center that includes a rehabilitation room and recreational riding center. POPULATION: Forty-five patients were arbitrarily recruited to the experimental (N= 22) and control group (N=23). METHODS: Patients in the experimental group received 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks. The two groups attended a 60-minute session of Schroth's intervention, 3 times/ week for 10 weeks. Two-way ANOVA for between-group comparisons and independent t-test for within-group comparisons were used in the statistical analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

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
24 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

March 31, 2021

Last Update Submit

April 8, 2021

Conditions

Keywords

HippotherapyPulmonary FunctionIdiopathic Scoliosis

Outcome Measures

Primary Outcomes (5)

  • FVC in liters

    change in FVC measured Using Spiromaster PC-10 Spirometer

    ten weeks

  • FEV1 in liters

    change in FEV1 measured Using Spiromaster PC-10 Spirometer

    ten weeks

  • MVV in liters/min

    change in MVV measured Using Spiromaster PC-10 Spirometer

    ten weeks

  • FEV1/FVC in percentage

    change in FEV1/FVC measured Using Spiromaster PC-10 Spirometer

    ten weeks

  • aerobic capacity

    6MWT

    ten weeks

Study Arms (2)

hippotherapy combined with Schroth Exercise

EXPERIMENTAL

received hippotherapy combined with Schroth Exercise hippotherapy session for 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks in addition to 60-minute session Schroth's intervention, 3 times/ week for 10 weeks

Other: hippotherapy and schroth exercise

Schroth Exercise

ACTIVE COMPARATOR

received Schroth's intervention for a 60-minute session, 3 times/ week for 10 weeks

Other: schroth exercise

Interventions

pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise

hippotherapy combined with Schroth Exercise

pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise

Schroth Exercise

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • all types of curves,
  • curves between 10 and 20 degrees (29),
  • Risser grade 0 to 5
  • the availability to be engaged in once a week visit

You may not qualify if:

  • Adolescents with:
  • obstructive pulmonary diseases
  • associated neuromuscular diseases
  • recent infectious episodes in the previous two months
  • history of cardiovascular or psychological disorders
  • any significant history of riding horses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Battarjee Medical College

Jeddah, 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

  • Mohamed M. Abdel Ghafar, Ph.D

    Batterjee Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 6, 2021

Study Start

February 20, 2020

Primary Completion

December 18, 2020

Study Completion

March 7, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations