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
1 other identifier
interventional
39
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedFebruary 29, 2016
February 1, 2016
2 months
February 1, 2016
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
EXPERIMENTALProprioceptive exercises performed 3 sessions per week for 4weeks
Control
NO INTERVENTIONWithout any exercises
Interventions
Eligibility Criteria
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
- 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 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