NCT02694107

Brief 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) .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

February 1, 2016

Last Update Submit

February 23, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Proprioceptive exercises

EXPERIMENTAL

Proprioceptive exercises performed 3 sessions per week for 4weeks

Other: Proprioceptive exercisesOther: Control

Control

NO INTERVENTION

Without any exercises

Interventions

Proprioceptive exercises
ControlOTHER
Proprioceptive exercises

Eligibility Criteria

Age25 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of physical therapy

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 29, 2016

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 29, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share