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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02694107
Other study ID # FF1972
Secondary ID
Status Completed
Phase N/A
First received February 1, 2016
Last updated February 23, 2016
Start date July 2015
Est. completion date October 2015

Study information

Verified date February 2016
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical 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 group(n=19, no intervention) .


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive exercises

Control


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Outcome

Type Measure Description Time frame Safety issue
Primary 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). up to 20 weeks Yes
Primary 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). up to 24 weeks Yes
Primary 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). up to 32 weeks Yes
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