Balance; DistortedNCT04793321
Impact of Baby Carrying Methods on Females Balance During Standing
A study testing Baby carrier, Biodex Balance System and Infant mannequin in people with Balance; Distorted, run by Hamada Ahmed at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Baby carrier, Biodex Balance System and Infant mannequin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Dec 2020to 17 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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?
- Conditions
- Balance; Distorted
- Being tested
- Baby carrier, Biodex Balance System, Infant mannequin, Biodex gait trainer 2 TM
- Keywords
- Biodex, baby caryying methods, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby carrierDevice
- 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 SystemDevice
- 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.
Infant mannequinOther
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 .
Biodex gait trainer 2 TMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Baby carrier; Device: Biodex Balance System; Other: Infant mannequin; Device: Biodex gait trainer 2 TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
APSI
Anterior-Posterior Stability Index
Measured: 20 second
MLSI
Medial-Lateral Stability Index
Measured: 20 second
OSI
the Overall Stability Index
Measured: 20 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start29 Dec 2020
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Balance; DistortedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamada Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamada Ahmed, Cairo University
- Investigators
- Prof. Dr. Amel Mohamed Yousef, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793321
- Sponsor's protocol ID
- baby carrying methods
- Status last verified
- Sep 2020
- First submitted
- 1 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24630464Brown 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.
PubMed 29244534
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Baby Carrying Methods on Females Balance During Standing
- ClinicalTrials.gov ID
- NCT04793321
- Acronym / sponsor ID
- baby carrying methods
- Conditions
- Balance; Distorted
- Keywords
- Biodex, baby caryying methods, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hamada AhmedUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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?
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| healty nulliparous females | Other | Device: Baby carrier, Device: Biodex Balance System, Other: Infant mannequin, Device: Biodex gait trainer 2 TMeach 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). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Subjects were excluded if they had the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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/" | Device | healty nulliparous females |
| 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. | Device | healty nulliparous females |
| Infant mannequinThe 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 . | Other | healty nulliparous females |
| Biodex gait trainer 2 TMGait 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 | Device | healty nulliparous females |
Primary outcome
APSI
Time frame: 20 second
Anterior-Posterior Stability Index
MLSI
Time frame: 20 second
Medial-Lateral Stability Index
OSI
Time frame: 20 second
the Overall Stability Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 24630464Inanir 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.
- Background: PubMed 29244534Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Amel Mohamed Yousef, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby carrier, Biodex Balance System and Infant mannequin in people with Balance; Distorted, run by Hamada Ahmed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APSI (time frame: 20 second). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793321, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.