Down SyndromeNCT05330741
Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome
A study testing Designed Physical Therapy Program, Whole-Body Vibration and Gravity Force Stimulation in people with Down Syndrome, run by Beni-Suef University.
Trial summary
The purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with Down syndrome. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Designed Physical Therapy Program, Whole-Body Vibration and Gravity Force Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2022to 9 Jul 2022
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages will be ranged from 8 to 10 years old.
- Functional hearing and vision.
- Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale)
- Independent standing and walking.
Who cannot join
- Synptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with Down syndrome.
Read the detailed description
Down Syndrome (DS) is one of genetic disorders characterized by some common clinical and functional features. Most children with Down syndrome have deficits in postural stability or balance, co-ordination, gait, and functional mobility throughout childhood and adulthood. Postural control dysfunctions are the most common problems found in children with DS leads them to be more inactive, which contributes to functional mobility problems. Several techniques that involve proprioceptive, vestibular, and visual inputs are so beneficial to children with DS. Whole-body vibration (WBV) is one of the training methods that use high-frequency mechanical stimuli generated by a vibrating platform and transmitted through the body, leading to bone loading and sensory receptor stimulation. Gravity force stimulation (GFS) has a strong impact on the child's sensory system helping to normalize the system through exercises that send strong messages to the brain to regulate the tactile, proprioceptive and vestibular components. Hence, there is need to compare between the effects of whole-body vibration training and gravity force stimulation on postural stability in children with Down syndrome.
- Conditions
- Down Syndrome
- Being tested
- Designed Physical Therapy Program, Whole-Body Vibration, Gravity Force Stimulation
- Keywords
- Whole-Body Vibration, Gravity Force Stimulation, Biodex Balance System, Down Syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Designed Physical Therapy ProgramOther
The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
Whole-Body VibrationOther
The designed physical therapy program (mentioned before)
+ Whole-body vibration (WBV) training, child will be asked to stand with slightly flexed knees (30 degrees of knee flexion), and both feet will be placed at an equal distance from the center of the platform to achieve an equal distribution of body weight over both feet. The device will set to produce a peak-to-peak sinusoidal vibration with an amplitude of 2 mm and a vibration frequency ranged from 25 to 30 Hz. WBV will applied for (30 sec. of WBV, 1 min rest, 10 repetitions), (45 sec. of WBV, 1 min rest, 10 repetitions), (60 sec. of WBV, 1 min rest, 10 repetitions) in the 1st, 2nd. and 3rd. months respectively.
Gravity Force StimulationOther
The designed physical therapy program (mentioned before)
+ Gravity force stimulation child will be asked to maintain his balance on GFS during each of the following positions as a progression (standing and walking on the surface of two beams connecting the two boxes - standing and walking crossly on the surface of one beam connecting the two boxes - standing and walking sideward on the surface of one beam connecting the two boxes - standing and walking on the edge of the two beams - standing and walking on the edge of one beam: most difficult)
| Study group | Role | What they receive |
|---|---|---|
| Designed Physical Therapy Program | Experimental | Designed Physical Therapy Program Down syndrome children will receive the designed physical therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Designed Physical Therapy Program |
| Whole-Body Vibration | Experimental | Designed physical therapy program in addition to whole-body vibration. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to whole-body vibration with an amplitude of 2 mm, vibration frequency ranged from 25 to 30 Hz and, vibration time ranged from 5 to10 minutes. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Designed Physical Therapy Program; Other: Whole-Body Vibration |
| Gravity Force Stimulation | Experimental | Designed physical therapy program in addition to gravity force stimulation. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to gravity force stimulation with 10 repetitions for each position. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Designed Physical Therapy Program; Other: Gravity Force Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability
Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
Measured: Up to 12 weeks
Secondary outcomes (1)
Functional Mobility
Six-minute walk test will be used for measuring functional mobility. It is a sub-maximal test of aerobic capacity, in which the subjects walk as far as possible in 6 minutes (min.) around a premeasured distance
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start9 Apr 2022 (estimated)
- Primary completion9 Jul 2022 (estimated)
- Study completion9 Jul 2022 (estimated)
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
- Model description
- Designed Physical Therapy program, Whole Body Vibration and, Gravity Force Stimulation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wagdy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330741
- Sponsor's protocol ID
- P.T.REC/012/003598
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05330741
- Acronym / sponsor ID
- P.T.REC/012/003598
- Conditions
- Down Syndrome
- Keywords
- Whole-Body Vibration, Gravity Force Stimulation, Biodex Balance System, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 9 Apr 2022 (estimated)
- Primary completion
- 9 Jul 2022 (estimated)
- Study completion
- 9 Jul 2022 (estimated)
- First posted
- 15 Apr 2022 (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.
The purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with Down syndrome.
Detailed description
Down Syndrome (DS) is one of genetic disorders characterized by some common clinical and functional features. Most children with Down syndrome have deficits in postural stability or balance, co-ordination, gait, and functional mobility throughout childhood and adulthood. Postural control dysfunctions are the most common problems found in children with DS leads them to be more inactive, which contributes to functional mobility problems. Several techniques that involve proprioceptive, vestibular, and visual inputs are so beneficial to children with DS. Whole-body vibration (WBV) is one of the training methods that use high-frequency mechanical stimuli generated by a vibrating platform and transmitted through the body, leading to bone loading and sensory receptor stimulation. Gravity force stimulation (GFS) has a strong impact on the child's sensory system helping to normalize the system through exercises that send strong messages to the brain to regulate the tactile, proprioceptive and vestibular components. Hence, there is need to compare between the effects of whole-body vibration training and gravity force stimulation on postural stability in children with Down syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Designed Physical Therapy program, Whole Body Vibration and, Gravity Force Stimulation
| Arm | Type | Receives |
|---|---|---|
| Designed Physical Therapy Program | Experimental | Other: Designed Physical Therapy ProgramDesigned Physical Therapy Program Down syndrome children will receive the designed physical therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks. |
| Whole-Body Vibration | Experimental | Other: Designed Physical Therapy Program, Other: Whole-Body VibrationDesigned physical therapy program in addition to whole-body vibration. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to whole-body vibration with an amplitude of 2 mm, vibration frequency ranged from 25 to 30 Hz and, vibration time ranged from 5 to10 minutes. The duration of treatment will be 3 times/week for 12 weeks. |
| Gravity Force Stimulation | Experimental | Other: Designed Physical Therapy Program, Other: Gravity Force StimulationDesigned physical therapy program in addition to gravity force stimulation. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to gravity force stimulation with 10 repetitions for each position. The duration of treatment will be 3 times/week for 12 weeks. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages will be ranged from 8 to 10 years old.
- Functional hearing and vision.
- Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale)
- Independent standing and walking.
Key exclusion criteria (5 listed)
- Synptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
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 |
|---|---|---|
| Designed Physical Therapy ProgramThe designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down. | Other | Designed Physical Therapy Program, Gravity Force Stimulation, Whole-Body Vibration |
| Whole-Body VibrationThe designed physical therapy program (mentioned before) + Whole-body vibration (WBV) training, child will be asked to stand with slightly flexed knees (30 degrees of knee flexion), and both feet will be placed at an equal distance from the center of the platform to achieve an equal distribution of body weight over both feet. The device will set to produce a peak-to-peak sinusoidal vibration with an amplitude of 2 mm and a vibration frequency ranged from 25 to 30 Hz. WBV will applied for (30 sec. of WBV, 1 min rest, 10 repetitions), (45 sec. of WBV, 1 min rest, 10 repetitions), (60 sec. of WBV, 1 min rest, 10 repetitions) in the 1st, 2nd. and 3rd. months respectively. | Other | Whole-Body Vibration |
| Gravity Force StimulationThe designed physical therapy program (mentioned before) + Gravity force stimulation child will be asked to maintain his balance on GFS during each of the following positions as a progression (standing and walking on the surface of two beams connecting the two boxes - standing and walking crossly on the surface of one beam connecting the two boxes - standing and walking sideward on the surface of one beam connecting the two boxes - standing and walking on the edge of the two beams - standing and walking on the edge of one beam: most difficult) | Other | Gravity Force Stimulation |
Primary outcome
Postural Stability
Time frame: Up to 12 weeks
Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
1 secondary outcome
Functional Mobility
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
Related trials for Down Syndrome
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
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.
Questions about this trial
What is this clinical trial studying?
A study testing Designed Physical Therapy Program, Whole-Body Vibration and Gravity Force Stimulation in people with Down Syndrome, run by Beni-Suef University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Wagdy (01008079576, Eman.wagdy@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability (time frame: Up to 12 weeks). 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 15 Apr 2022.