Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children

Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children-A Randomized Controlled Trial

According to the World Health Organization (WHO) and United Nations Children's Fund (UNICEF), one billion people suffer from physical and mental disabilities, with 240 million children. Whereas 26.4 million belong to Asia, and approximately 5 million are from Pakistan. The Centre for Disease Control and Prevention (CDC) reports developmental disorders as one of the leading causes of these disabilities. Several conditions are classified under this domain, including Autism Spectrum Disorder, Attention-Deficit Hyperactivity Disorder, Down syndrome, and Cerebral Palsy. Down syndrome (DS) has recently emerged as a prevailing condition in low-and middle-income countries, with an incidence of 1 in every 300 babies. DS is a genetic disorder due to the triplication of all or some parts of the 21st chromosome. Various problems characterize this disability, including; compromised motor skills proficiency and altered gait parameters. These deficits have been addressed using numerous effective techniques, one of which is 'Simulated Equestrian Therapy'. Despite advances in rehabilitating DS patients, a scarcity of literature still surfaces regarding using these simulators and their effects. To our knowledge, no study in Pakistan has been conducted to evaluate motor proficiency and gait parameters in the DS population using this intervention. Therefore, the present study is aimed to assess the effects of simulated equestrian therapy on motor proficiency and gait parameters in DS children.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Device: Simulated Equestrian Therapy; Other: Neuro-Motor Therapy

Detailed Description

A total of 58 participants will be recruited for this study after obtaining informed voluntary assent from the guardians. Simple random sampling using the envelop method will be used for the group allocation, to which the participants will be blind. Each participant will be allocated randomly to the treatment group (n=29) that will receive Simulated Equestrian Therapy and the control group (n=29) to receive Neuromotor Therapy. Each participant will be assessed at baseline, after 6 and 12 weeks of intervention using Bruinink's test of motor proficiency (BOT-2) and 10 meter walk test (10MWT). Each participant's blood pressure and heart rate will also be recorded before each session to ensure safety. The participants will be wearing protective gear (belt, helmet, knee and elbow pads) and portable telemetry during the entire session. The session duration in both groups will comprise 30-45 minutes on average, varying with the progression each week. Each session will be provided three times/a week for 3 months.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75000
      • Ziauddin University and Dar-ul-Sukoon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals with diagnosed DS are referred by a physician.
• Age 6-12 years.
• Ability to independently walk, GMFCS level-I.

Exclusion Criteria:

• Diagnosed atlantoaxial instability.
• Diagnosed osteoarticular, pulmonary or cardiovascular disorders.
• Diagnosed severe behavioral or cognitive impairment.
• Severe visual impairment that cannot be corrected with glasses.
• If equestrian therapy received in the last 1-year.
• Refusal of parents/guardians to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simulated Equestrian Therapy; The treatment group will receive Simulated Equestrian Therapy using 2 horse simulators (wooden and mechanical). Each participant will undergo a warm-up before phase I and cool-down after phase II. The treatment will be divided into following 2 phases; Phase I The child will be instructed to ride the mechanical simulator in a pre-defined area measuring 10 yards and complete a total of 4 rounds of this area. Rest periods in between and after will be provided to the child when required. Major muscles of the body will be targeted here to strengthen the core. Phase II The child will be instructed to ride the wooden simulator and a combination of goal directed activates will be performed every week for 12 weeks in the following manner; 0-2 weeks: Practicing catching and throwing. 3-5 weeks: Placing the ball, and rings on the target. 6-8 weeks: Target hitting on a game of dart. 9-12 weeks: Leaning to the head, feet, and tail of the horse	Device: Simulated Equestrian Therapy; The treatment group will receive Simulated Equestrian Therapy for 12 weeks thrice per week using 2 horse simulators (wooden and mechanical) in two phases. Phase I The child will be instructed to ride the mechanical simulator in a pre-defined area measuring 10 yards and complete a total of 4 rounds of this area. Rest periods in between and after will be provided to the child when required. Major muscles of the body will be targeted here to strengthen the core. Phase II The child will be instructed to ride the wooden simulator and a combination of goal directed activates will be performed.
Active Comparator: Neuro-Motor Therapy; This group will perform overall stability and body balancing exercises to strengthen the core and develop the coordination and balance required for task performance. Each activity will be performed in a set of 2-3, considering the activity level of the child, with 8-12 repetitions attaining the available ROM and flexibility of the child thrice for three weeks. The participants will undergo warm-up before the exercise and cool-down afterwards.	Other: Neuro-Motor Therapy; This group will perform overall stability and body balancing exercises to strengthen the core and develop the coordination and balance required for task performance. Each activity will be performed in a set of 2-3, considering the activity level of the child, with 8-12 repetitions attaining the available ROM and flexibility of the child. The participants will undergo warm-up before the exercise and cool-down afterwards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilateral Coordination	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	Baseline
Bilateral Coordination	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	6 weeks after intervention
Bilateral Coordination	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	12 weeks after intervention
Balance	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	Baseline
Balance	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	6 weeks after intervention
Balance	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	12 weeks after intervention
Speed agility	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	Baseline
Speed agility	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	6 weeks after intervention
Speed agility	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	12 weeks after intervention
Strength	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	Baseline
Strength	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	6 weeks after intervention
Strength	Motor proficiency is a combination of 4 skills including; bilateral coordination, balance, speed agility, and strength. All of these subsets of motor proficiency are assessed via a battery known as Bruinink's test of motor proficiency, BOT 2. It is a questionnaire that is filled out by the examiner after the successful motor performance of the examinee and scores are given for each attempt. These scores for each subset are summed at the end and a composite score is obtained that indicates the value of motor proficiency of an individual.	12 weeks after intervention
Cadence	In this study cadence and gait velocity are considered as Parameters of Gait. Both of these parameters are recorded via 10-meter walk test. In this test, the individual walks at their usual comfortable speed at a distance of 10 meters, the speed of walking (gait velocity) is recorded via stopwatch, and the number of steps taken (cadence) are counted as well by the examiner.	Baseline
Cadence	In this study cadence and gait velocity are considered as Parameters of Gait. Both of these parameters are recorded via 10-meter walk test. In this test, the individual walks at their usual comfortable speed at a distance of 10 meters, the speed of walking (gait velocity) is recorded via stopwatch, and the number of steps taken (cadence) are counted as well by the examiner.	6 weeks after intervention
Cadence	In this study cadence and gait velocity are considered as Parameters of Gait. Both of these parameters are recorded via 10-meter walk test. In this test, the individual walks at their usual comfortable speed at a distance of 10 meters, the speed of walking (gait velocity) is recorded via stopwatch, and the number of steps taken (cadence) are counted as well by the examiner.	12 weeks after intervention
Gait Velocity	In this study cadence and gait velocity are considered as Parameters of Gait. Both of these parameters are recorded via 10-meter walk test. In this test, the individual walks at their usual comfortable speed at a distance of 10 meters, the speed of walking (gait velocity) is recorded via stopwatch, and the number of steps taken (cadence) are counted as well by the examiner.	Baseline
Gait Velocity	In this study cadence and gait velocity are considered as Parameters of Gait. Both of these parameters are recorded via 10-meter walk test. In this test, the individual walks at their usual comfortable speed at a distance of 10 meters, the speed of walking (gait velocity) is recorded via stopwatch, and the number of steps taken (cadence) are counted as well by the examiner.	6 weeks after intervention
Gait Velocity	In this study cadence and gait velocity are considered as Parameters of Gait. Both of these parameters are recorded via 10-meter walk test. In this test, the individual walks at their usual comfortable speed at a distance of 10 meters, the speed of walking (gait velocity) is recorded via stopwatch, and the number of steps taken (cadence) are counted as well by the examiner.	12 weeks after intervention

Collaborators and Investigators

• Sponsor: Ziauddin University
• Investigators: Study Director: Sumaira Farooqui, PhD, Ziauddin University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: 6803223MHREH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No