Clinical trial NCT05912803: Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children
Official title: Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bilateral Coordination
timeFrame: Baseline
measure: Bilateral Coordination
timeFrame: 6 weeks after intervention
measure: Bilateral Coordination
timeFrame: 12 weeks after intervention
measure: Balance
timeFrame: Baseline
measure: Balance
timeFrame: 6 weeks after intervention
measure: Balance
timeFrame: 12 weeks after intervention
measure: Speed agility
timeFrame: Baseline
measure: Speed agility
timeFrame: 6 weeks after intervention
measure: Speed agility
timeFrame: 12 weeks after intervention
measure: Strength
timeFrame: Baseline
measure: Strength
timeFrame: 6 weeks after intervention
measure: Strength
timeFrame: 12 weeks after intervention
measure: Cadence
timeFrame: Baseline
measure: Cadence
timeFrame: 6 weeks after intervention
measure: Cadence
timeFrame: 12 weeks after intervention
measure: Gait Velocity
timeFrame: Baseline
measure: Gait Velocity
timeFrame: 6 weeks after intervention
measure: Gait Velocity
timeFrame: 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University and Dar-ul-Sukoon
state: Sindh
Study officials:
affiliation: Ziauddin University
name: Sumaira Farooqui, PhD
role: STUDY_DIRECTOR
References: