Down SyndromeNCT06838754
Effect of Whole Body Vibration on Down Syndrome
A study testing Whole body vibration therapy and Routine physical therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
A congenital condition known as Down syndrome is typified by an excess of genetic material from chromosome 21, making 47 chromosomes in total. Development of the body and brain may be impacted. About 1 in 700-1100 live births have the condition, and 1 in 700-1100 live births inherit it. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Whole body vibration therapy and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2024to 7 Mar 2025
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 5-12
- Both sexes are chosen
- Children with Down syndrome older than 5 who are more knowledgeable about the exercise to be done are given preference.
Who cannot join
- Children with cardiac conditions and other conditions
- Atlantoaxial instability and prosthesis implantation are excluded.
- DS kids who don't have their parents or legal guardians sign the consent form.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54700
About this study
Official title: Effects of Whole Body Vibration on Gait Parameters and Postural Control in Children With Down Syndrome
A congenital condition known as Down syndrome is typified by an excess of genetic material from chromosome 21, making 47 chromosomes in total. Development of the body and brain may be impacted. About 1 in 700-1100 live births have the condition, and 1 in 700-1100 live births inherit it. Heart disease, hypotonia, ligament laxity, cerebral disabilities, thyroid abnormalities, and metabolic diseases are among the physical, cognitive, and metabolic changes that define it. Reduced performance, increased energy consumption, and altered gait patterns are frequently the results of motor disorders. This study intends to ascertain the effects of whole body vibrations (WBV), an activity that has been recommended for individuals with Down syndrome, on gait parameters and postural control in children with this condition.
Read the detailed description
Whole Body Vibration (WBV) and routine physical therapy (RPT) are given to Group A, whereas routine physical therapy is given to Group B as a control. Two sessions of 20 minutes each are given to both groups twice a week. Postural control and gait metrics are the outcomes that will be examined. The present investigation will be conducted over a two-month period and will be a randomized control experiment. Alkhidmat Hospital in Sargodha and Al-Ghafoor Hospital in Bhera will provide the data. 16 participants will participate in the trial; they will be randomly assigned to two equal groups. Children with DS, ages 5 to 12, of both sexes, will be eligible to participate in the study. The condition of improved comprehension of children older than five years was taken into consideration when determining the inclusion criteria.
- Conditions
- Down Syndrome
- Being tested
- Whole body vibration therapy, Routine physical therapy
- Keywords
- Down syndrome, Motor skills, Vibrations
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration therapyOther
Experimental group will get whole body vibrations. WBV will be performed by the patient while seated on the vibrating plate's base. Five series with a 30-second wait will make up each session. Five minutes and thirty seconds will be spent on vibration, and twenty minutes and thirty seconds will be spent on exercise. 5 Hz will be the frequency utilized. Over the course of two months, 16 classes will be held twice a week.
Routine physical therapyOther
Group B will only get routine physical therapy. Walking in all directions, advancing past the point of stability in a variety of positions, including half-kneeling, standing on both soft and hard surfaces, stepping up and down, walking and standing simultaneously, and standing on one leg with eyes open and closed were all part of the postural control exercise. There will be a 20-minute session.As each participant's functional improvement progresses, the intensity of the workout program will progressively rise. There will be 16 sessions in total (two days a week), with 8 sessions for each group.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration therapy | Experimental | Experimental group will receive whole body vibrations while sitting. Walking in all directions, Receives: Other: Whole body vibration therapy |
| Routine physical therapy | Other | Group B will be the only one performing routine physical therapy (RPT). Stretching exercises will be part of these regular workouts. Walking in all directions, Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length
Step length will be measured from consecutive heel contacts in cm.
Measured: 2 months.
Posture and postural ability test (PPAS)
The PPAS assesses 4 positions. Standing, sitting, supine and prone Each position is assessed according to the postural ability, quality of posture and within postural ability seven levels are designated, ranging from Level 1 = 'Unplaceable in an aligned posture' to 7 = Able to move into and out of position.
Measured: 2 months.
Stride length
Stride length is the distance between the previous heel strike of the right foot and the new heel strike of the right foot and measured in cm.
Measured: 2 months.
Step width
Step width will be measured from the mediolateral space between the two feet in cm.
Measured: 2 months.
Foot angle
Foot angle will be measured by the angle between the line of progression and the foot axis in degree.
Measured: 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start28 Oct 2024
- Primary completion23 Feb 2025
- Study completion7 Mar 2025
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 randomised control trial in which non probability snowball sampling will be used. Two groups of 5-12 age will be performed in which participants will be randomly divided. Group A will be receive Whole body Vibrations and routine physical therapy and Group B will be receive routine therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuba Sameen, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838754
- Sponsor's protocol ID
- REC/RCR & AHS/24/0716
- Status last verified
- Mar 2025
- First submitted
- 3 Nov 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yaqoob M, Manzoor J, Hyder SN, Sadiq M. Congenital heart disease and thyroid dysfunction in Down syndrome reported at Children;s Hospital, Lahore, Pakistan. Turk J Pediatr. 2019;61(6):915-924. doi: 10.24953/turkjped.2019.06.013.
PubMed 32134586
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration on Gait Parameters and Postural Control in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06838754
- Acronym / sponsor ID
- REC/RCR & AHS/24/0716
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Motor skills, Vibrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 21 Feb 2025 (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.
A congenital condition known as Down syndrome is typified by an excess of genetic material from chromosome 21, making 47 chromosomes in total. Development of the body and brain may be impacted. About 1 in 700-1100 live births have the condition, and 1 in 700-1100 live births inherit it. Heart disease, hypotonia, ligament laxity, cerebral disabilities, thyroid abnormalities, and metabolic diseases are among the physical, cognitive, and metabolic changes that define it. Reduced performance, increased energy consumption, and altered gait patterns are frequently the results of motor disorders. This study intends to ascertain the effects of whole body vibrations (WBV), an activity that has been recommended for individuals with Down syndrome, on gait parameters and postural control in children with this condition.
Detailed description
Whole Body Vibration (WBV) and routine physical therapy (RPT) are given to Group A, whereas routine physical therapy is given to Group B as a control. Two sessions of 20 minutes each are given to both groups twice a week. Postural control and gait metrics are the outcomes that will be examined. The present investigation will be conducted over a two-month period and will be a randomized control experiment. Alkhidmat Hospital in Sargodha and Al-Ghafoor Hospital in Bhera will provide the data. 16 participants will participate in the trial; they will be randomly assigned to two equal groups. Children with DS, ages 5 to 12, of both sexes, will be eligible to participate in the study. The condition of improved comprehension of children older than five years was taken into consideration when determining the inclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomised control trial in which non probability snowball sampling will be used. Two groups of 5-12 age will be performed in which participants will be randomly divided. Group A will be receive Whole body Vibrations and routine physical therapy and Group B will be receive routine therapy.
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration therapy | Experimental | Other: Whole body vibration therapyExperimental group will receive whole body vibrations while sitting. Walking in all directions, |
| Routine physical therapy | Other | Other: Routine physical therapyGroup B will be the only one performing routine physical therapy (RPT). Stretching exercises will be part of these regular workouts. Walking in all directions, |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 5-12
- Both sexes are chosen
- Children with Down syndrome older than 5 who are more knowledgeable about the exercise to be done are given preference.
Key exclusion criteria (3 listed)
- Children with cardiac conditions and other conditions
- Atlantoaxial instability and prosthesis implantation are excluded.
- DS kids who don't have their parents or legal guardians sign the consent form.
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 |
|---|---|---|
| Whole body vibration therapyExperimental group will get whole body vibrations. WBV will be performed by the patient while seated on the vibrating plate's base. Five series with a 30-second wait will make up each session. Five minutes and thirty seconds will be spent on vibration, and twenty minutes and thirty seconds will be spent on exercise. 5 Hz will be the frequency utilized. Over the course of two months, 16 classes will be held twice a week. | Other | Whole body vibration therapy |
| Routine physical therapyGroup B will only get routine physical therapy. Walking in all directions, advancing past the point of stability in a variety of positions, including half-kneeling, standing on both soft and hard surfaces, stepping up and down, walking and standing simultaneously, and standing on one leg with eyes open and closed were all part of the postural control exercise. There will be a 20-minute session.As each participant's functional improvement progresses, the intensity of the workout program will progressively rise. There will be 16 sessions in total (two days a week), with 8 sessions for each group. | Other | Routine physical therapy |
Primary outcome
Step length
Time frame: 2 months.
Step length will be measured from consecutive heel contacts in cm.
Posture and postural ability test (PPAS)
Time frame: 2 months.
The PPAS assesses 4 positions. Standing, sitting, supine and prone Each position is assessed according to the postural ability, quality of posture and within postural ability seven levels are designated, ranging from Level 1 = 'Unplaceable in an aligned posture' to 7 = Able to move into and out of position.
Stride length
Time frame: 2 months.
Stride length is the distance between the previous heel strike of the right foot and the new heel strike of the right foot and measured in cm.
Step width
Time frame: 2 months.
Step width will be measured from the mediolateral space between the two feet in cm.
Foot angle
Time frame: 2 months.
Foot angle will be measured by the angle between the line of progression and the foot axis in degree.
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 20 Mar 2025.
- Background: PubMed 32134586Yaqoob M, Manzoor J, Hyder SN, Sadiq M. Congenital heart disease and thyroid dysfunction in Down syndrome reported at Children;s Hospital, Lahore, Pakistan. Turk J Pediatr. 2019;61(6):915-924. doi: 10.24953/turkjped.2019.06.013.
- Individual participant dataSharing planned: No
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
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.
Tuba Sameen, 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 Whole body vibration therapy and Routine physical therapy 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 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 20 Mar 2025. 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?
Step length (time frame: 2 months.). The study lists 5 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 NCT06838754, 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 20 Mar 2025.