Down SyndromeNCT05951543
Effects of Plyometric Exercises on Static and Dynamic Balance of Children With Down,s Syndrome.
A study testing plyometric exercises in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down syndrome is a condition in which a person has an extra chromosome. Typically, a baby is born with 46 chromosomes. Down syndrome is a genetic condition that causes mild to serious physical and developmental problems. 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?
- plyometric exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 23 May 2023to 15 Sep 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
- 6 to 12 years of age both genders will be included.
- Children with medical diagnosis of DS.
- Able to follow the command
Who cannot join
- Recent injury to lower extremities.
- Children with cerebral palsy and other neuromuscular disease will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Plyometric Exercises on Static and Dynamic Balance in Children With Down,s Syndrome
Down syndrome is a condition in which a person has an extra chromosome. Typically, a baby is born with 46 chromosomes. Down syndrome is a genetic condition that causes mild to serious physical and developmental problems. Symptoms associated with the syndrome include mental retardation, distinctive facial characteristics, and increased risk for heart defects and digestive problems, which can range from mild to severe.. Early treatment programs can help improve skills. They may include speech, physical, occupational, and/or educational therapy. The aim of the the current study is to determine the effects of plyometric exercise on static and dynamic balance in children with Down syndrome
Read the detailed description
This will be a randomized controlled trail. After approval from ethical committee, data will be collected from rising sun institute of special education, Lahore. Total sample size will be 20 and there will be two groups. Group A will be given with Standard Physical therapy treatment twice a week for 8 weeks. While group B will be given with plyometric exercises along with standard physical therapy treatment twice a week for 8 weeks. Patients will be evaluated before and after the intervention on Pediatric balance scale, time up and go test, five times sit to stand. Data will be analyzed on SPSS 26.0 and necessary analysis will be done after checking the normality of data.
- Conditions
- Down Syndrome
- Being tested
- plyometric exercises, dynamic balance group control group
- Keywords
- Balance, Dynamic, Down syndrome, Plyometric, Static.
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plyometric exercisesOther
Also called Balance
Experimental group will be given baseline exercises along with plyometric exercises such as Vertical jump, run and jump, drop jump (jump height between 40 and 50 cm) drop jump and horizontal jump with same height from 3rd week.particepents perform exercises carrying medicine balls. Participants will place their hands on the wall and performed foot stretches with the feet apart, 30 to 50 cm from the wall. Side row, biceps stretch and frontal row. Throwing and receiving, with a distance between 3 to 4 m.
dynamic balance group control groupOther
Control group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises
| Study group | Role | What they receive |
|---|---|---|
| plyometric group | Experimental | Experimental group will be given baseline exercises along with plyometric exercises such as Vertical jump, run and jump, drop jump (jump height between 40 and 50 cm) drop jump and horizontal jump with same height from 3rd week.particepents perform exercises carrying medicine balls. Participants will place their hands on the wall and performed foot stretches with the feet apart, 30 to 50 cm from the wall. Side row, biceps stretch and frontal row. Throwing and receiving, with a distance between 3 to 4 m. Receives: Other: plyometric exercises |
| dynamic balance group control group | Other | Control group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises Receives: Other: dynamic balance group control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance and standing
Paediatric berg balance scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start23 May 2023
- Primary completion31 Aug 2023
- Study completion15 Sep 2023
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 is a randomize control trail ,used to evaluate the effects of plyometric exercises on static and dynamic balance of children with down syndrome.subjects with down syndrome meeting the predetermine inclusion and exclusion criteria will be devided into two groups using simple random sampling technique.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Khalid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951543
- Sponsor's protocol ID
- REC/RCR&AHS/23/0709
- Status last verified
- Nov 2023
- First submitted
- 6 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elnaggar RK. Effects of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hemiplegic cerebral palsy. Physiother Theory Pract. 2022 Sep;38(9):1165-1173. doi: 10.1080/09593985.2020.1833389. Epub 2020 Oct 12.
PubMed 33044886
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plyometric Exercises on Static and Dynamic Balance in Children With Down,s Syndrome
- ClinicalTrials.gov ID
- NCT05951543
- Acronym / sponsor ID
- REC/RCR&AHS/23/0709
- Conditions
- Down Syndrome
- Keywords
- Balance, Dynamic, Down syndrome, Plyometric, Static.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 Jul 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.
Down syndrome is a condition in which a person has an extra chromosome. Typically, a baby is born with 46 chromosomes. Down syndrome is a genetic condition that causes mild to serious physical and developmental problems. Symptoms associated with the syndrome include mental retardation, distinctive facial characteristics, and increased risk for heart defects and digestive problems, which can range from mild to severe.. Early treatment programs can help improve skills. They may include speech, physical, occupational, and/or educational therapy. The aim of the the current study is to determine the effects of plyometric exercise on static and dynamic balance in children with Down syndrome
Detailed description
This will be a randomized controlled trail. After approval from ethical committee, data will be collected from rising sun institute of special education, Lahore. Total sample size will be 20 and there will be two groups. Group A will be given with Standard Physical therapy treatment twice a week for 8 weeks. While group B will be given with plyometric exercises along with standard physical therapy treatment twice a week for 8 weeks. Patients will be evaluated before and after the intervention on Pediatric balance scale, time up and go test, five times sit to stand. Data will be analyzed on SPSS 26.0 and necessary analysis will be done after checking the normality of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a randomize control trail ,used to evaluate the effects of plyometric exercises on static and dynamic balance of children with down syndrome.subjects with down syndrome meeting the predetermine inclusion and exclusion criteria will be devided into two groups using simple random sampling technique.
| Arm | Type | Receives |
|---|---|---|
| plyometric group | Experimental | Other: plyometric exercisesExperimental group will be given baseline exercises along with plyometric exercises such as Vertical jump, run and jump, drop jump (jump height between 40 and 50 cm) drop jump and horizontal jump with same height from 3rd week.particepents perform exercises carrying medicine balls. Participants will place their hands on the wall and performed foot stretches with the feet apart, 30 to 50 cm from the wall. Side row, biceps stretch and frontal row. Throwing and receiving, with a distance between 3 to 4 m. |
| dynamic balance group control group | Other | Other: dynamic balance group control groupControl group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 to 12 years of age both genders will be included.
- Children with medical diagnosis of DS.
- Able to follow the command
Key exclusion criteria (2 listed)
- Recent injury to lower extremities.
- Children with cerebral palsy and other neuromuscular disease will be excluded.
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 |
|---|---|---|
| plyometric exercisesAlso: BalanceExperimental group will be given baseline exercises along with plyometric exercises such as Vertical jump, run and jump, drop jump (jump height between 40 and 50 cm) drop jump and horizontal jump with same height from 3rd week.particepents perform exercises carrying medicine balls. Participants will place their hands on the wall and performed foot stretches with the feet apart, 30 to 50 cm from the wall. Side row, biceps stretch and frontal row. Throwing and receiving, with a distance between 3 to 4 m. | Other | plyometric group |
| dynamic balance group control groupControl group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises | Other | dynamic balance group control group |
Primary outcome
Balance and standing
Time frame: 8 weeks
Paediatric berg balance scale
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 13 Nov 2023.
- Background: PubMed 33044886Elnaggar RK. Effects of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hemiplegic cerebral palsy. Physiother Theory Pract. 2022 Sep;38(9):1165-1173. doi: 10.1080/09593985.2020.1833389. Epub 2020 Oct 12.
- 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.
Ayesha 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 plyometric exercises 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 3 inclusion and 2 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 13 Nov 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?
Balance and standing (time frame: 8 weeks). 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 NCT05951543, 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 13 Nov 2023.