Down SyndromeNCT06502652
Hippotherapy Versus Balance Therapy on Funvtional Mobility in Down Syndrome
A study testing hippotherapy and balance training in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down Syndrome is a genetic condition caused by having an extra copy of chromosome 21 and 47 chromosomes instead of 46. A complete or partial extra copy of chromosome 21 is responsible for the anomaly and related structural and functional abnormalities of the body systems. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- hippotherapy and balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 30 Jul 2024
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group of 6-14 years
- Both genders
Who cannot join
- Children with fixed deformity in LE
- Child with visual and hearing problems
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Hippo Therapy Versus Balance Training on Balance and Functional Mobility in Children With Down's Syndrome
Down Syndrome is a genetic condition caused by having an extra copy of chromosome 21 and 47 chromosomes instead of 46. A complete or partial extra copy of chromosome 21 is responsible for the anomaly and related structural and functional abnormalities of the body systems. Depending on the degree of abnormality, Down Syndrome has different impacts on different people as a result, differences exist in personality, abilities, talents, and physical and mental development. According to this syndrome the patients shared characteristics with one another that suggested they were siblings, including a broad, flat face, a small nose, a thick tongue, narrow palpebral fissures, obliquely positioned eyes, roundish and laterally extended cheeks, a long tongue, and varying degrees of intellectual impairment.
Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent release to participate in the project and to process personal data for scientific purposes. This study aimed to determine the effects of hippo therapy versus balance training on balance and functional mobility in children with Down's Syndrome. Randomized clinical trials will be done. The study will be conducted in special school of education, Sargodha and Najeeb ullah rehabilitation centre, Sargodha in 10 months duration after approval of synopsis. Evaluation will be done by using pediatric balance scale, times up to go test, Functional independence measure for children, Tug test for functional mobility. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation through lottery method; group A will be receiving hippo therapy and group B will be receiving balance training. Both groups will receive 8 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Data will be analyzed using SPSS-21.
Read the detailed description
GROUP A:
Group A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally
GROUP B Group B includes balance training. The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes
- Conditions
- Down Syndrome
- Being tested
- hippotherapy, balance training
- Keywords
- Balance training,, Down syndrome,, Hippotherapy
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hippotherapyOther
A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally
balance trainingOther
The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| hippotherapy | Experimental | Group A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally Receives: Other: hippotherapy |
| balance training | Active comparator | The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes Receives: Other: balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEDIATRIC BALANCE SCALE
It is modified berg scale the 14 items on the scale are: standing balance, sitting balance, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool
Measured: 4 weeks
TIMES UP TO GO TEST
The TUG was performed from a chair 40 cm high. Participants were instructed to stand and walk 3 m to a designated area at a regular pace, then turn and return to the starting position, with the time to finish being recorded. Each participant received two trials, with the best time noted.
Measured: 4 weeks
FUNCTIONAL INDEPENDENCE MEASURE
The maximum score on each of the 18 elements in the FIM is 7, the minimum score is 1, and the maximum possible score is 126 points. The 18 items in the FIM can be split down into two categories: five items for assessing cognitive ADL (which includes two items for communication and three items for social cognition) and thirteen items for testing motor ADL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jun 2024
- Primary completion15 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- it will be randomized controlled trial which is non probability sampling will be used. two groups of 6-14 years age will be performed in which participants will be randomly divided.group a will recieve hippotherapy and group b will recieve balance training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- faiza khalid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502652
- Sponsor's protocol ID
- REC/RCR&AHS/23/0797
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baburamani AA, Patkee PA, Arichi T, Rutherford MA. New approaches to studying early brain development in Down syndrome. Dev Med Child Neurol. 2019 Aug;61(8):867-879. doi: 10.1111/dmcn.14260. Epub 2019 May 17.
PubMed 31102269
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hippo Therapy Versus Balance Training on Balance and Functional Mobility in Children With Down's Syndrome
- ClinicalTrials.gov ID
- NCT06502652
- Acronym / sponsor ID
- REC/RCR&AHS/23/0797
- Conditions
- Down Syndrome
- Keywords
- Balance training,, Down syndrome,, Hippotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 16 Jul 2024 (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.
Down Syndrome is a genetic condition caused by having an extra copy of chromosome 21 and 47 chromosomes instead of 46. A complete or partial extra copy of chromosome 21 is responsible for the anomaly and related structural and functional abnormalities of the body systems. Depending on the degree of abnormality, Down Syndrome has different impacts on different people as a result, differences exist in personality, abilities, talents, and physical and mental development. According to this syndrome the patients shared characteristics with one another that suggested they were siblings, including a broad, flat face, a small nose, a thick tongue, narrow palpebral fissures, obliquely positioned eyes, roundish and laterally extended cheeks, a long tongue, and varying degrees of intellectual impairment.
Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent release to participate in the project and to process personal data for scientific purposes. This study aimed to determine the effects of hippo therapy versus balance training on balance and functional mobility in children with Down's Syndrome. Randomized clinical trials will be done. The study will be conducted in special school of education, Sargodha and Najeeb ullah rehabilitation centre, Sargodha in 10 months duration after approval of synopsis. Evaluation will be done by using pediatric balance scale, times up to go test, Functional independence measure for children, Tug test for functional mobility. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation through lottery method; group A will be receiving hippo therapy and group B will be receiving balance training. Both groups will receive 8 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Data will be analyzed using SPSS-21.
Detailed description
GROUP A:
Group A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally
GROUP B Group B includes balance training. The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it will be randomized controlled trial which is non probability sampling will be used. two groups of 6-14 years age will be performed in which participants will be randomly divided.group a will recieve hippotherapy and group b will recieve balance training.
| Arm | Type | Receives |
|---|---|---|
| hippotherapy | Experimental | Other: hippotherapyGroup A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally |
| balance training | Active comparator | Other: balance trainingThe therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age group of 6-14 years
- Both genders
Key exclusion criteria (3 listed)
- Children with fixed deformity in LE
- Child with visual and hearing problems
- History of epilepsy
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 |
|---|---|---|
| hippotherapyA hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally | Other | hippotherapy |
| balance trainingThe therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes | Other | balance training |
Primary outcome
PEDIATRIC BALANCE SCALE
Time frame: 4 weeks
It is modified berg scale the 14 items on the scale are: standing balance, sitting balance, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool
TIMES UP TO GO TEST
Time frame: 4 weeks
The TUG was performed from a chair 40 cm high. Participants were instructed to stand and walk 3 m to a designated area at a regular pace, then turn and return to the starting position, with the time to finish being recorded. Each participant received two trials, with the best time noted.
FUNCTIONAL INDEPENDENCE MEASURE
Time frame: 4 weeks
The maximum score on each of the 18 elements in the FIM is 7, the minimum score is 1, and the maximum possible score is 126 points. The 18 items in the FIM can be split down into two categories: five items for assessing cognitive ADL (which includes two items for communication and three items for social cognition) and thirteen items for testing motor ADL
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 2 Aug 2024.
- Background: PubMed 31102269Baburamani AA, Patkee PA, Arichi T, Rutherford MA. New approaches to studying early brain development in Down syndrome. Dev Med Child Neurol. 2019 Aug;61(8):867-879. doi: 10.1111/dmcn.14260. Epub 2019 May 17.
- Individual participant dataSharing planned: No
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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.
faiza khalid, MS principal investigator
Riphah International 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 hippotherapy and balance training in people with Down Syndrome, run by Riphah International 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 2 inclusion and 3 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 2 Aug 2024. 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?
PEDIATRIC BALANCE SCALE (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502652, which also lists 1 linked publication.
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 2 Aug 2024.