DisturbanceNCT02694107
Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy
A study testing Proprioceptive exercises in people with Disturbance and Balance, run by Kafrelsheikh University.
Trial summary
The purpose of the present study was to measure the effect of proprioceptive training, short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up. Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which would perform proprioceptive exercise, or the control… 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
- Disturbance, Balance, Pregnancy
- What is being tested?
- Proprioceptive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2015
- 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 25 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maternal age between 25 and 30 years,
- Gestational age was 20 weeks gestation,
- Body mass index not exceeding 30 kg/m2,
- Low risk pregnancy,
- Single fetus,
- Healthy sensory motor function in the lower limbs.
Who cannot join
- Gestational diabetes,
- Pre-eclampsia,
- Toxemia,
- Gestational hypertension,
- Previous abortion,
- High-risk pregnancy,
Show all 14Show fewer
- Type I or Type II diabetes ,
- Any condition that could affect sensation,
- A leg or foot fracture or ankle or knee sprain within the last year,
- Current back or knee pain,
- Cardiovascular, neurologic, neuromuscular, or pulmonary disease,
- Vertigo, balance or any visual problems,or psychological illness.
- Current smokers,
- Currently taking any medication that would affect their ability to balance.
About this study
Official title: A Randomized Controlled Trial of Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy
The purpose of the present study was to measure the effect of proprioceptive training, short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.
Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which would perform proprioceptive exercise, or the control group(n=19, no intervention) .
Read the detailed description
Improvement in the postural balance of pregnant women may be the improvement in joint mechanoreceptor activation present in the joint capsules, medial ligament, posterior cruciate ligament, and meniscus, which result in improved articular stabilization and, consequently, a possible increase in the musculature's ability to provide co-contraction.
Improved their postural control after the intervention may have been due to central and peripheral nervous system balance control circuits and strength gains, which showed improvements extending from the second to the third trimester . The maintenance of postural balance requires the integration of the visual, vestibular, and somatosensory systems.
At the spinal level, first level of motor control, nervous reflex movement patterns are received from higher levels of the nervous system. This provides for reflex splinting during conditions of abnormal stress about the joint and has significant implications for rehabilitation.The muscle spindles play a major role in the control of muscular movement by adjusting activity in the lower motor neurons.
The second level of motor control is the brain stem, where the joint afferent is relayed to maintain the posture and balance of the body. Information delivered to the brain stem emanates from the joint proprioceptors, the vestibular centers in the ears, and the eyes.The final aspect of motor control includes the highest level of CNS function (motor cortex, basal ganglia, and cerebellum)and is mediated by cognitive awareness of body position and movement. Movements that are repeated can be stored as central commands, and can be performed without continuous reference to consciousness. This better joint afferent between the peripheral and central nervous system control may be reflected in the improvement of balance during pregnancy, as observed in this study as a result of proprioceptive training delivered to pregnant women.
- Conditions
- Disturbance, Balance, Pregnancy
- Being tested
- Proprioceptive exercises, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive exercisesOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive exercises | Experimental | Proprioceptive exercises performed 3 sessions per week for 4weeks Receives: Other: Proprioceptive exercises; Other: Control |
| Control | No intervention | Without any exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 20 weeks gestation
Dynamic balance(AP,ML and GPS) indices were measured by the Biodex Balance System at 20 weeks gestation(WG).
Measured: up to 20 weeks
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 24 weeks gestation
Dynamic balance(AP,ML and GPS) indices were measured by the Biodex Balance System at 24 weeks gestation(WG).
Measured: up to 24 weeks
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 32 weeks gestation
Dynamic balance(AP,ML and GPS) indices were measured by the Biodex Balance System at 32 weeks gestation(WG).
Measured: up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisturbanceStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fayiz Elshamy, Kafrelsheikh University
- Investigators
- Ana Paula Ribeiro, Prof. Dr, Study chair, Department of Physical Therapy, Laboratory of Biomechanics and Rehabilitation Musculoskeletal, University of Santo Amaro and Researcher at the University of São Paulo, São Paulo, Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694107
- Sponsor's protocol ID
- FF1972
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy
- ClinicalTrials.gov ID
- NCT02694107
- Acronym / sponsor ID
- FF1972
- Conditions
- Disturbance, Balance, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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 present study was to measure the effect of proprioceptive training, short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.
Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which would perform proprioceptive exercise, or the control group(n=19, no intervention) .
Detailed description
Improvement in the postural balance of pregnant women may be the improvement in joint mechanoreceptor activation present in the joint capsules, medial ligament, posterior cruciate ligament, and meniscus, which result in improved articular stabilization and, consequently, a possible increase in the musculature's ability to provide co-contraction.
Improved their postural control after the intervention may have been due to central and peripheral nervous system balance control circuits and strength gains, which showed improvements extending from the second to the third trimester . The maintenance of postural balance requires the integration of the visual, vestibular, and somatosensory systems.
At the spinal level, first level of motor control, nervous reflex movement patterns are received from higher levels of the nervous system. This provides for reflex splinting during conditions of abnormal stress about the joint and has significant implications for rehabilitation.The muscle spindles play a major role in the control of muscular movement by adjusting activity in the lower motor neurons.
The second level of motor control is the brain stem, where the joint afferent is relayed to maintain the posture and balance of the body. Information delivered to the brain stem emanates from the joint proprioceptors, the vestibular centers in the ears, and the eyes.The final aspect of motor control includes the highest level of CNS function (motor cortex, basal ganglia, and cerebellum)and is mediated by cognitive awareness of body position and movement. Movements that are repeated can be stored as central commands, and can be performed without continuous reference to consciousness. This better joint afferent between the peripheral and central nervous system control may be reflected in the improvement of balance during pregnancy, as observed in this study as a result of proprioceptive training delivered to pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive exercises | Experimental | Other: Proprioceptive exercises, Other: ControlProprioceptive exercises performed 3 sessions per week for 4weeks |
| Control | No intervention | –Without any exercises |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Maternal age between 25 and 30 years,
- Gestational age was 20 weeks gestation,
- Body mass index not exceeding 30 kg/m2,
- Low risk pregnancy,
- Single fetus,
Key exclusion criteria (14 listed)
- Gestational diabetes,
- Pre-eclampsia,
- Toxemia,
- Gestational hypertension,
- Previous abortion,
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 exercises | Other | Proprioceptive exercises |
| Control | Other | Proprioceptive exercises |
Primary outcome
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 20 weeks gestation
Time frame: up to 20 weeks
Dynamic balance(AP,ML and GPS) indices were measured by the Biodex Balance System at 20 weeks gestation(WG).
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 24 weeks gestation
Time frame: up to 24 weeks
Dynamic balance(AP,ML and GPS) indices were measured by the Biodex Balance System at 24 weeks gestation(WG).
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 32 weeks gestation
Time frame: up to 32 weeks
Dynamic balance(AP,ML and GPS) indices were measured by the Biodex Balance System at 32 weeks gestation(WG).
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 29 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Ana Paula Ribeiro, Prof. Dr study chair
Department of Physical Therapy, Laboratory of Biomechanics and Rehabilitation Musculoskeletal, University of Santo Amaro and Researcher at the University of São Paulo, São Paulo, Brazil.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive exercises in people with Disturbance and Balance, run by Kafrelsheikh 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 6 inclusion and 14 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 29 Feb 2016. 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?
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?
Anteroposterior (AP), mediolateral (ML), and global postural sway(GPS) indices were measured at 20 weeks gestation (time frame: up to 20 weeks). The study lists 3 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 29 Feb 2016.