- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694107
Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy
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) .
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Gestational diabetes,
- Pre-eclampsia,
- Toxemia,
- Gestational hypertension,
- Previous abortion,
- High-risk pregnancy,
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proprioceptive exercises
Proprioceptive exercises performed 3 sessions per week for 4weeks
|
|
No Intervention: Control
Without any exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 20 weeks
|
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).
|
up to 24 weeks
|
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).
|
up to 32 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ana Paula Ribeiro, Prof. Dr, 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FF1972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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