Impact of Baby Carrying Methods on Females Balance During Standing
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
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
December 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2021
CompletedFirst Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedMarch 11, 2021
September 1, 2020
2 months
March 1, 2021
March 9, 2021
Conditions
Keywords
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
OTHEReach 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).
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/"
* 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.
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 .
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
Eligibility Criteria
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
- Hamada Ahmedlead
Study Sites (1)
Faculty of Physical Therapy/ Cairo University
Giza, Dokki, Egypt
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: 24630464BACKGROUNDBrown 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
- PRINCIPAL INVESTIGATOR
Prof. Dr. Amel Mohamed Yousef, Professor
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- 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