Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04793321
Other study ID # baby carrying methods
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 29, 2020
Est. completion date February 17, 2021

Study information

Verified date September 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Babywearing is defined as using a supporting device that helps to keep an infant close to a caregiver's trunk. The practice of babywearing has many benefits to both children and caregivers as it is an extension of "skin-to-skin care (SSC)" or "kangaroo care" which has well-known therapeutic benefits. Such benefits for the infant include: improve physical and cognitive state, good sleep, less likely to continuously cry, better breastfeeding, temperature stability. For mothers, many benefits were found as well for example lower stress and anxiety levels, decrease in heart rate HR and blood pressure BP, higher breastfeeding rates, increase maternal satisfaction, increased bonding of mother with their neonate . Despite the great advantage of infant carrying, there are many adverse effects on the musculoskeletal system and ergonomics of the mother. Women who carry their babies throughout the day will probably have similar consequences as carrying an extra load so pain and injuries will occur. It has been reported that infant carrying in-arms caused acute muscle soreness in the ipsilateral upper limb that was used to support the infant over the left shoulder. While during the front infant carrying methods (ICMs), the pressure of the infant carrier shoulder straps caused shoulder discomfort and pain. The front infant carrying position has the next highest fatigue score as it results in lower Metabolic equivalent (METS) and VO2max value which means that it places significant demand on the metabolic system. It have been reported that the increased cost of carrying an infant in one's arms is the cause for the development of infant carrying tools rapidly. Infant carrying is a form of exterogestation, just like in pregnancy, there is an alteration that swings the center of gravity of the body, shifts the postural balance, and increases the risk of falls . Contrariwise, the usage of the carrier resulted in more similar postural control variables to the unloaded condition. Mannen and colleagues advised the use of babywearing as it provides a mechanical advantage to the caregiver. Surprisingly, no study so far has quantified the actual balance changes with different carrying methods (including carrying in arms and carrying in a baby carrier) during typical movements of daily life, such as walking or standing upright. Previous research has indicated that carrying externals loads elicits an increase in the center of pressure (COP) measures of postural sway during quiet standing . Mathew W. Hill & Price reported that holding external loads during standing is an important issue for many daily and occupational activities and these external loads can affect postural stability, which is important for the mother's and fetus's safety. Also, holding a load in the hand may have restricted and/or delayed postural reactions. From this perspective, both carrying methods are considered extra load and the question is that there any carrying methods that have an advantage over others concerning balance?


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 17, 2021
Est. primary completion date February 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: 1. Had normal menstrual cycles. 2. All females were recruited on a day other than mese days. 3. Their age ranged from 20 to 35 years old. 4. Their body mass index ranged from 18-30 kg/m². 5. Had no experience with babywearing or in arm-carrying methods Exclusion Criteria: - Subjects were excluded if they had the following criteria: 1. Females who had irregular menstrual cycles. 2. Females who used oral contraceptive drugs or hormonal supplementary and injections through the previous 3 months. 3. Females who had Musculoskeletal disorders or pain in the upper and lower extremities in the prior 6 months. 4. Females complained of knee, ankle, or back pain. 5. Females with a severe chronic illness that interfere with balance such as vestibular dysfunction. 6. Any health condition that could interfere with the ability to maintain balance was excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Baby carrier
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/"
Biodex Balance System
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.
Other:
Infant mannequin
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 .
Device:
Biodex gait trainer 2 TM
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

Locations

Country Name City State
Egypt Faculty of Physical Therapy/ Cairo University Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Hamada Ahmed

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary APSI Anterior-Posterior Stability Index 20 second
Primary MLSI Medial-Lateral Stability Index 20 second
Primary OSI the Overall Stability Index 20 second
See also
  Status Clinical Trial Phase
Recruiting NCT04568070 - Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients N/A
Completed NCT05056298 - Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot N/A
Recruiting NCT04538690 - The Effect of Exercise Therapy in Painful Shoulder Disorders N/A
Completed NCT05420194 - Assessment of Postural Stability in Patients With Total Knee Arthroplasty
Completed NCT03307265 - Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder. N/A
Completed NCT06003868 - Investigation of the Effect of Hippotherapy Simulator in Children With Spastic Diplegia and Cerebral Palsy N/A
Completed NCT06006533 - Fascia Release Techniques Applied to Plantar Flexor Muscles and Acute Efficacy of Kinesio Taping N/A
Completed NCT04334746 - The Discriminative Ability of the Four Balance Measures for Fall History
Completed NCT04919161 - Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke N/A
Recruiting NCT04700605 - Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.
Completed NCT04622657 - Validity Reliability of The Dubousset Functional Test in Parkinson Disease N/A
Completed NCT04615533 - Validity Reliability of FrailBESTest in Older Adults
Completed NCT03538756 - walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis N/A
Active, not recruiting NCT01265134 - Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly N/A
Completed NCT04595292 - Validity Reliability of The Dubousset Functional Test in Older Adults
Completed NCT04834141 - Correlation Between Thoracic Kyphosis Posture and Static Balance
Completed NCT05344755 - Effects of Plantar Sensory Training in Individuals With Hallux Valgus. N/A
Recruiting NCT03881930 - Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy N/A
Completed NCT04627558 - Validity Reliability of The Dubousset Functional Test in Stroke Patients
Enrolling by invitation NCT05115461 - Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy