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

NCT ID: NCT05912803

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-29
• Study Completion Date: 2023-08-25

Brief Summary

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.

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.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Simulated Equestrian Therapy

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Neuro-Motor Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Maha Siddiqui

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sumaira Farooqui, PhD

Role: STUDY_DIRECTOR

Ziauddin University

Locations

Ziauddin University and Dar-ul-Sukoon

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

6803223MHREH

Identifier Type: -

Identifier Source: org_study_id