NCT04793321

Brief Summary

The purpose of this study was to investigate the effect of different baby carrying methods (including carrying in arms and carrying in a baby carrier) in the females' balance during standing and walking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

March 1, 2021

Last Update Submit

March 9, 2021

Conditions

Keywords

Biodexbaby caryying methodsBalance

Outcome Measures

Primary Outcomes (3)

  • APSI

    Anterior-Posterior Stability Index

    20 second

  • MLSI

    Medial-Lateral Stability Index

    20 second

  • OSI

    the Overall Stability Index

    20 second

Study Arms (1)

healty nulliparous females

OTHER

each participant did three conditions: 1. holding nothing (unloaded). 2. holding an infant mannequin in arms(arms). 3. holding an infant mannequin in the baby carrier(carriers).

Device: Baby carrierDevice: Biodex Balance SystemOther: Infant mannequinDevice: Biodex gait trainer 2 TM

Interventions

* It is made in china. * It is made of Cotton-Polyester. * It has 3 belts - 2 shoulder belts and one waist belt for superior lumbar support. Shoulder straps are padded and adjustable for the parent's comfort. It has webbing straps for shoulder and waist strap adjustment. * It is suitable for newborn to 12-months baby * It is available online at babyshopstores "https://www.babyshopstores.com/"

healty nulliparous females

* The Biodex Balance System SD (The Biodex Balance System SD Model 945-300, 115 VAC, Shirley, NY, USA) is used to assess the balance in this study. * It is an objective device that measures dynamic postural stability. It uses a circular platform that allows up to 20˚of of platform tilt in a 360˚ range of motion. * The measures of postural stability score for BBS are the Overall Stability Index (OSI), Medial-Lateral Stability Index (MLSI), and Anterior-Posterior Stability Index (APSI). These indices are standard deviations that assess the path of sway around the zero point from the center of the platform and are measured in degrees. A high score in these stability indices indicates poor balance.

healty nulliparous females

The mannequin infant has 3 Kg which corresponds to the infant's age from birth until 1month. This weight is selected as it corresponds to the age at which the infants are frequently carried by the mother .

healty nulliparous females

Gait Trainer 2™ ( model number:950-385, 115 VAC 50/60 Hz, made in the USA) is used for participants to walk on as walking is one of the most common daily life activities. because caregivers commonly walk while carrying their infants as it has a calming effect on crying infants It consists of : * Display: Use Audio and Visual Biofeedback - real-time biofeedback prompts patients into a proper gait pattern. * Heart Rate Monitoring * Handrail * Open Platform

healty nulliparous females

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Had normal menstrual cycles.
  • All females were recruited on a day other than mese days.
  • Their age ranged from 20 to 35 years old.
  • Their body mass index ranged from 18-30 kg/m².
  • Had no experience with babywearing or in arm-carrying methods

You may not qualify if:

  • Subjects were excluded if they had the following criteria:
  • Females who had irregular menstrual cycles.
  • Females who used oral contraceptive drugs or hormonal supplementary and injections through the previous 3 months.
  • Females who had Musculoskeletal disorders or pain in the upper and lower extremities in the prior 6 months.
  • Females complained of knee, ankle, or back pain.
  • Females with a severe chronic illness that interfere with balance such as vestibular dysfunction.
  • Any health condition that could interfere with the ability to maintain balance was excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy/ Cairo University

Giza, Dokki, Egypt

Location

Related Publications (2)

  • Inanir A, Cakmak B, Hisim Y, Demirturk F. Evaluation of postural equilibrium and fall risk during pregnancy. Gait Posture. 2014 Apr;39(4):1122-5. doi: 10.1016/j.gaitpost.2014.01.013. Epub 2014 Feb 2.

    PMID: 24630464BACKGROUND
  • Brown MB, Digby-Bowl CJ, Todd SD. Assessing Infant Carriage Systems: Ground Reaction Force Implications for Gait of the Caregiver. Hum Factors. 2018 Mar;60(2):160-171. doi: 10.1177/0018720817744661. Epub 2017 Dec 15.

    PMID: 29244534BACKGROUND

Study Officials

  • Prof. Dr. Amel Mohamed Yousef, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A single group repeated measures design was used under which each participant had their balance tested during three conditions: 1. holding nothing (unloaded). 2. holding an infant mannequin in arms(arms). 3. holding an infant mannequin in the baby carrier(carriers).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Biomechanics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 11, 2021

Study Start

December 29, 2020

Primary Completion

February 17, 2021

Study Completion

February 17, 2021

Last Updated

March 11, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations