Down S SyndromeNCT05392309
Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
A study testing Manual ankle rocking training and Conventional in people with Down S Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Down S Syndrome
- What is being tested?
- Manual ankle rocking training and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 31 Oct 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed children with down syndrome
- Age 8 to 15
- Both gender (male and female)
Who cannot join
- Musculoskeletal contractures
- Visual or other sensory input impairment
- Any surgical procedure
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rising Sun Institute For Special Children, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. Strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening. Aim of this research is to determine the effects of manual Ankle rocking training on postural control and foot function in children with Down syndrome. Those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for Ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by SPSS. 22
- Conditions
- Down S Syndrome
- Being tested
- Manual ankle rocking training, Conventional
- Keywords
- Down syndrome, Postural control, Postural stability, Balance
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ankle rocking trainingOther
Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk
ConventionalOther
Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week
| Study group | Role | What they receive |
|---|---|---|
| Manual ankle rocking training | Experimental | Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk Receives: Other: Manual ankle rocking training; Other: Conventional |
| conventional | Active comparator | Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in foot function index score
A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced.
Measured: Baseline and 9th week
Static standing balance test
Static standing balance test for postural control and stability
Measured: baseline and 9th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Mar 2022
- Primary completion15 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Down S 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392309
- Sponsor's protocol ID
- REC/RCR & AHS/22/0704
- Status last verified
- Jan 2023
- First submitted
- 23 May 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balan V, Georgescu M. Postural control in Down syndrome subjects. European Proceedings of Social and Behavioural Sciences. 2019;11.
Palomba A, Perez D, Tafuri D. THE EFFECTS OF PHYSICAL ACTIVITY ON BALANCE AND POSTURAL CONTROL IN PEOPLE WITH DOWN SYNDROME.
Shields N, Lim P, Wollersheim D, Nikolopoulos N, Barrett J, Evans A, et al. Do foot posture, deformity, and footwear fit influence physical activity levels in children with Down syndrome? A prospective cohort study. Journal of Intellectual & Developmental Disability. 2017;42(4):332-8
Wang HY, Long IM, Liu MF. Relationships between task-oriented postural control and motor ability in children and adolescents with Down syndrome. Res Dev Disabil. 2012 Nov-Dec;33(6):1792-8. doi: 10.1016/j.ridd.2012.05.002. Epub 2012 Jun 13.
PubMed 22699252Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.
PubMed 32273655Eltohamy AM, Mahran MA, Elassal MI, Kamel AH. Ankle Rocking Training and Functional Abilities in Children with Cerebral Palsy. The Egyptian Journal of Hospital Medicine. 2021;85(1):3301-5
Chen HL, Yeh CF, Howe TH. Postural control during standing reach in children with Down syndrome. Res Dev Disabil. 2015 Mar;38:345-51. doi: 10.1016/j.ridd.2014.12.024. Epub 2015 Jan 13.
PubMed 25590172Brugnaro BH, Oliveira MFP, de Campos AC, Pavao SL, Rocha NACF. Postural control in Down syndrome and relationships with the dimensions of the International Classification of Functioning, Disability and Health - a systematic review. Disabil Rehabil. 2022 Jun;44(11):2207-2222. doi: 10.1080/09638288.2020.1830439. Epub 2020 Oct 13.
PubMed 33049152
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05392309
- Acronym / sponsor ID
- REC/RCR & AHS/22/0704
- Conditions
- Down S Syndrome
- Keywords
- Down syndrome, Postural control, Postural stability, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 26 May 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.
Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. Strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening. Aim of this research is to determine the effects of manual Ankle rocking training on postural control and foot function in children with Down syndrome. Those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for Ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by SPSS. 22
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual ankle rocking training | Experimental | Other: Manual ankle rocking training, Other: ConventionalGroup will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk |
| conventional | Active comparator | Other: ConventionalGroup will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed children with down syndrome
- Age 8 to 15
- Both gender (male and female)
Key exclusion criteria (3 listed)
- Musculoskeletal contractures
- Visual or other sensory input impairment
- Any surgical procedure
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 |
|---|---|---|
| Manual ankle rocking trainingGroup will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk | Other | Manual ankle rocking training |
| ConventionalGroup will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week | Other | Manual ankle rocking training, conventional |
Primary outcome
Changes in foot function index score
Time frame: Baseline and 9th week
A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced.
Static standing balance test
Time frame: baseline and 9th week
Static standing balance test for postural control and stability
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 5 Jan 2023.
- BackgroundBalan V, Georgescu M. Postural control in Down syndrome subjects. European Proceedings of Social and Behavioural Sciences. 2019;11.
- BackgroundPalomba A, Perez D, Tafuri D. THE EFFECTS OF PHYSICAL ACTIVITY ON BALANCE AND POSTURAL CONTROL IN PEOPLE WITH DOWN SYNDROME.
- BackgroundShields N, Lim P, Wollersheim D, Nikolopoulos N, Barrett J, Evans A, et al. Do foot posture, deformity, and footwear fit influence physical activity levels in children with Down syndrome? A prospective cohort study. Journal of Intellectual & Developmental Disability. 2017;42(4):332-8
- Background: PubMed 22699252Wang HY, Long IM, Liu MF. Relationships between task-oriented postural control and motor ability in children and adolescents with Down syndrome. Res Dev Disabil. 2012 Nov-Dec;33(6):1792-8. doi: 10.1016/j.ridd.2012.05.002. Epub 2012 Jun 13.
- Background: PubMed 32273655Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.
- BackgroundEltohamy AM, Mahran MA, Elassal MI, Kamel AH. Ankle Rocking Training and Functional Abilities in Children with Cerebral Palsy. The Egyptian Journal of Hospital Medicine. 2021;85(1):3301-5
- Background: PubMed 25590172Chen HL, Yeh CF, Howe TH. Postural control during standing reach in children with Down syndrome. Res Dev Disabil. 2015 Mar;38:345-51. doi: 10.1016/j.ridd.2014.12.024. Epub 2015 Jan 13.
- Background: PubMed 33049152Brugnaro BH, Oliveira MFP, de Campos AC, Pavao SL, Rocha NACF. Postural control in Down syndrome and relationships with the dimensions of the International Classification of Functioning, Disability and Health - a systematic review. Disabil Rehabil. 2022 Jun;44(11):2207-2222. doi: 10.1080/09638288.2020.1830439. Epub 2020 Oct 13.
- Individual participant dataSharing planned: No
Related trials for Down S Syndrome
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
RecruitingPhase 3
Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome
Down Syndrome, Autonomic Dysfunction
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.
Sidra Afzal, PP-DPT 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 Manual ankle rocking training and Conventional in people with Down S 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 5 Jan 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?
Changes in foot function index score (time frame: Baseline and 9th week). The study lists 2 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 NCT05392309, which also lists 8 linked publications.
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 5 Jan 2023.