Pes Planus Down Syndrome PatientsNCT05251935
Down Syndrome and Effects of Foot Muscle Exercise
A study testing Foot Muscle Exercise Protocol and Arch Support Insole and One Leg Balance Activities in people with Pes Planus Down Syndrome Patients, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Down syndrome (DS) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical, Speech and Language development. Hypotonity and laxity that is part of its features causes delay on motor acquisition. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Pes Planus Down Syndrome Patients
- What is being tested?
- Foot Muscle Exercise Protocol and Arch Support Insole and One Leg Balance Activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Apr 2021to 30 Nov 2021
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Clinically diagnosed cases of DS including both male and female.
- Bilateral flexible pes planus on the basis of Navicular Drop Test.
- Able to follow instructions and adhere to the exercise program.
- Ambulating independently.
Who cannot join
- • Visual or auditory impairment.
- Lower limb trauma or surgical intervention past six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Foot Muscle Exercise on Gross Motor Function and Balance Among Pes Planus Down Syndrome Patients
Down syndrome (DS) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical, Speech and Language development. Hypotonity and laxity that is part of its features causes delay on motor acquisition. Furthermore it causes musculoskeletal issues and lower extremity malalignment resulting in inefficient and abnormal pattern of movement compromising locomotion and day to day functions therefore, problems for the population further aggravates. Combined effects of these factors causes a high level of stress on foot as it provides the foundation for whole body therefore, individuals with Down syndrome are at risk for foot alignment problems. Pes planus being the most common amongst them and accounts for 91% of the total DS patients diagnosed. Pes planus causes alteration in foot kinetics and kinematics that not only interferes significantly with normal daily life activities as balance and gait but also increases the risk of musculoskeletal injuries. Hence researchers have shown interest in addressing this condition for the effective management of DS population. Conventional treatment approach are the use of insoles, foot orthosis and arch taping however, they fail to produce residual effect. Hence the present study is to determine the role of foot muscles exercises in Down Syndrome having pes planus since its effects are positively recorded in normal population.
- Conditions
- Pes Planus Down Syndrome Patients
- Being tested
- Foot Muscle Exercise Protocol, Arch Support Insole and One Leg Balance Activities
- Keywords
- Down syndrome, foot deformities, muscle hypotonia, pes planus, joint laxity, exercise training
- Medical subject headings
- Down Syndrome, Foot Deformities, Muscle Hypotonia, Flatfoot, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Muscle Exercise ProtocolOther
Foot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program
Arch Support Insole and One Leg Balance ActivitiesCombination product
Arch Support Insoles were provided that the child had to wear for 5 hours per day thrice weekly for 6 months plus performed one leg balance activities
| Study group | Role | What they receive |
|---|---|---|
| Foot Muscle Exercise | Experimental | Not described Receives: Other: Foot Muscle Exercise Protocol |
| Arch Support Insole and One Leg Balance Activities | Active comparator | Not described Receives: Combination Product: Arch Support Insole and One Leg Balance Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Measured: Baseline
Gross Motor Function
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Measured: 12 weeks
Gross Motor Function
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Measured: 24 weeks
Balance
Balance was assessed using Pediatric Balance Scale
Measured: Baseline
Balance
Balance was assessed using Pediatric Balance Scale
Measured: 12 weeks
Balance
Balance was assessed using Pediatric Balance Scale
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start22 Apr 2021
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes Planus Down Syndrome PatientsStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazia Adeeb, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251935
- Sponsor's protocol ID
- Nazia Adeeb
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Muscle Exercise on Gross Motor Function and Balance Among Pes Planus Down Syndrome Patients
- ClinicalTrials.gov ID
- NCT05251935
- Acronym / sponsor ID
- Nazia Adeeb
- Conditions
- Pes Planus Down Syndrome Patients
- Keywords
- Down syndrome, foot deformities, muscle hypotonia, pes planus, joint laxity, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 23 Feb 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 (DS) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical, Speech and Language development. Hypotonity and laxity that is part of its features causes delay on motor acquisition. Furthermore it causes musculoskeletal issues and lower extremity malalignment resulting in inefficient and abnormal pattern of movement compromising locomotion and day to day functions therefore, problems for the population further aggravates. Combined effects of these factors causes a high level of stress on foot as it provides the foundation for whole body therefore, individuals with Down syndrome are at risk for foot alignment problems. Pes planus being the most common amongst them and accounts for 91% of the total DS patients diagnosed. Pes planus causes alteration in foot kinetics and kinematics that not only interferes significantly with normal daily life activities as balance and gait but also increases the risk of musculoskeletal injuries. Hence researchers have shown interest in addressing this condition for the effective management of DS population. Conventional treatment approach are the use of insoles, foot orthosis and arch taping however, they fail to produce residual effect. Hence the present study is to determine the role of foot muscles exercises in Down Syndrome having pes planus since its effects are positively recorded in normal population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot Muscle Exercise | Experimental | Other: Foot Muscle Exercise Protocol |
| Arch Support Insole and One Leg Balance Activities | Active comparator | Combination Product: Arch Support Insole and One Leg Balance Activities |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Clinically diagnosed cases of DS including both male and female.
Key exclusion criteria (2 listed)
- • Visual or auditory impairment.
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 |
|---|---|---|
| Foot Muscle Exercise ProtocolFoot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program | Other | Foot Muscle Exercise |
| Arch Support Insole and One Leg Balance ActivitiesArch Support Insoles were provided that the child had to wear for 5 hours per day thrice weekly for 6 months plus performed one leg balance activities | Combination product | Arch Support Insole and One Leg Balance Activities |
Primary outcome
Gross Motor Function
Time frame: Baseline
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Gross Motor Function
Time frame: 12 weeks
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Gross Motor Function
Time frame: 24 weeks
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Balance
Time frame: Baseline
Balance was assessed using Pediatric Balance Scale
Balance
Time frame: 12 weeks
Balance was assessed using Pediatric Balance Scale
Balance
Time frame: 24 weeks
Balance was assessed using Pediatric 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 23 Feb 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Muscle Exercise Protocol and Arch Support Insole and One Leg Balance Activities in people with Pes Planus Down Syndrome Patients, run by Ziauddin 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 4 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 23 Feb 2022. 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?
Gross Motor Function (time frame: Baseline). The study lists 6 primary outcomes in all. 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 23 Feb 2022.