Postural StabilityPhase 2/3NCT06354803
Effect of Pezzi Ball on Balance in Pregnant Women
A Phase 2/3 study testing proprioceptive training in people with Postural Stability, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum Read more about this study
- Who is it for?
- Ages 25 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Stability
- What is being tested?
- proprioceptive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2023to 3 Mar 2024
- Phase
- Phase 2/3
- 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 25 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 25 and 30 years a body mass index (BMI) not exceeding 32 kg/m2, low-risk gestation primiparous pregnancy intact sensory motor integration in the lower extremities.
Who cannot join
- more than 28 weeks gestation
- had chronic disease
- multiparous
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy kafrelshiekh university
Kafr ash Shaykh, Kafrelshiekh, 6850001
About this study
Official title: Amelioration of Kinaesthesia in Pregnant Women Using Pezzi Ball Exercises: Randomized Controlled Trial
The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum
Read the detailed description
The effect of kinaesthetic training using pezzi ball for 12 sessions with rate of 3 session per week on postural stability and performance during pregnancy and at the 2-week postpartum follow-up. Postural stability was measured using a balance check board 636-1
- Conditions
- Postural Stability
- Being tested
- proprioceptive training
- Keywords
- Kinaesthetic training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive trainingOther
Also called Standard antenatal care
Proprioceptive training using swiss ball for 12 sessions
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 23 women below 28 week gestation were received kinaesthetic exercises on the Pezzi ball and standard antenatal care Receives: Other: proprioceptive training |
| control group | No intervention | 22 women belowe 28 week gestation were received just standard antenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of postural stability
By the use of balance check board 636-1 the balance of pregnant women changed significantly which appears in change in the rate of falling
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start2 Mar 2023
- Primary completion2 Feb 2024
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural StabilityStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 45 participants with gestational age below 28 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed elsaied moghazy ahmed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354803
- Sponsor's protocol ID
- KafrelsheikhU 30
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amelioration of Kinaesthesia in Pregnant Women Using Pezzi Ball Exercises: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06354803
- Acronym / sponsor ID
- KafrelsheikhU 30
- Conditions
- Postural Stability
- Keywords
- Kinaesthetic training
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 9 Apr 2024 (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 effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum
Detailed description
The effect of kinaesthetic training using pezzi ball for 12 sessions with rate of 3 session per week on postural stability and performance during pregnancy and at the 2-week postpartum follow-up. Postural stability was measured using a balance check board 636-1
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 45 participants with gestational age below 28 weeks
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: proprioceptive training23 women below 28 week gestation were received kinaesthetic exercises on the Pezzi ball and standard antenatal care |
| control group | No intervention | –22 women belowe 28 week gestation were received just standard antenatal care |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between 25 and 30 years a body mass index (BMI) not exceeding 32 kg/m2, low-risk gestation primiparous pregnancy intact sensory motor integration in the lower extremities.
Key exclusion criteria (3 listed)
- more than 28 weeks gestation
- had chronic disease
- multiparous
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 |
|---|---|---|
| proprioceptive trainingAlso: Standard antenatal careProprioceptive training using swiss ball for 12 sessions | Other | intervention group |
Primary outcome
change of postural stability
Time frame: 1 month
By the use of balance check board 636-1 the balance of pregnant women changed significantly which appears in change in the rate of falling
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 9 Apr 2024.
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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.
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 Phase 2/3 study testing proprioceptive training in people with Postural Stability, run by Kafrelsheikh University at 1 site in Egypt.
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 1 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 9 Apr 2024. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change of postural stability (time frame: 1 month). 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 9 Apr 2024.