Down SyndromeNCT05912803
Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children
A study testing Simulated Equestrian Therapy and Neuro-Motor Therapy in people with Down Syndrome, run by Ziauddin University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Simulated Equestrian Therapy and Neuro-Motor Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jan 2023to 25 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Individuals with diagnosed DS are referred by a physician.
- Age 6-12 years.
- Ability to independently walk, GMFCS level-I.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Simulated Equestrian Therapy, Neuro-Motor Therapy
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Equestrian TherapyDevice
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Simulated Equestrian Therapy | Experimental | 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 Receives: Device: Simulated Equestrian Therapy |
| Neuro-Motor Therapy | Active comparator | 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. Receives: Other: Neuro-Motor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start29 Jan 2023
- Primary completion15 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Siddiqui, Ziauddin University
- Investigators
- Sumaira Farooqui, PhD, Study director, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912803
- Sponsor's protocol ID
- 6803223MHREH
- Status last verified
- Oct 2023
- First submitted
- 2 Jun 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simulated Equestrian Therapy on Motor Proficiency and Gait Parameters Among Down Syndrome Children-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05912803
- Acronym / sponsor ID
- 6803223MHREH
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulated Equestrian Therapy | Experimental | Device: Simulated Equestrian TherapyThe 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 |
| Neuro-Motor Therapy | Active comparator | Other: Neuro-Motor TherapyThis 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Individuals with diagnosed DS are referred by a physician.
- Age 6-12 years.
- Ability to independently walk, GMFCS level-I.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated Equestrian TherapyThe 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. | Device | Simulated Equestrian Therapy |
| Neuro-Motor TherapyThis 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. | Other | Neuro-Motor Therapy |
Primary outcome
Bilateral Coordination
Time frame: Baseline
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.
Bilateral Coordination
Time frame: 6 weeks after intervention
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.
Bilateral Coordination
Time frame: 12 weeks after intervention
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.
Balance
Time frame: Baseline
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.
Balance
Time frame: 6 weeks after intervention
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.
Balance
Time frame: 12 weeks after intervention
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.
Speed agility
Time frame: Baseline
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.
Speed agility
Time frame: 6 weeks after intervention
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.
Speed agility
Time frame: 12 weeks after intervention
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.
Strength
Time frame: Baseline
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.
Strength
Time frame: 6 weeks after intervention
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.
Strength
Time frame: 12 weeks after intervention
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.
Cadence
Time frame: Baseline
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.
Cadence
Time frame: 6 weeks after intervention
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.
Cadence
Time frame: 12 weeks after intervention
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.
Gait Velocity
Time frame: Baseline
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.
Gait Velocity
Time frame: 6 weeks after intervention
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.
Gait Velocity
Time frame: 12 weeks after intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumaira Farooqui, PhD study director
Ziauddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated Equestrian Therapy and Neuro-Motor Therapy in people with Down Syndrome, run by Ziauddin University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral Coordination (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.