Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807122461346 Date of Approval: 17/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of front infant carrying method on selected gait parameters and cost of energy on young females.
Official scientific title Effect of front infant carrying on selected gait parameters and cost of energy .
Brief summary describing the background and objectives of the trial carrying is one of the essential tasks in child care. Among the cost of reproduction, carrying one's infant incurs one of the greatest drains on maternal energy because of added mass(Wall-Scheffler et al.,2007). It involves the various method of holding and transporting infant that is be achieved by using tools to support the infant on various position on the trunk or carrying the child in the arms. The need for infant carrying cannot be under estimated despite the energy draining implications on the mother and its effect on gait parameters The front wrap infant carrying method is usually achieved by carrying an infant in front of the torso by using a single piece of cloth or baby carrier that wraps around the mother and over her shoulders. It is found in the Mayan society and among westerners today in form of front sling and pouch baby carrier.The front infant carrying for the study includes,the upper front carrying method,the mid front carrying method,lower front carrying method .: The objectives of the study includes the effect of vertical trunk loading on the step length,stride length ,cadence and walking velocity. Also the evaluation of upper,mid d lower trunk loading on the cardio respirator indices which are heart rate,respiratory rate and the oxygen saturation rate and finally evaluation of various front vertical trunk loading on energy cost demands .The energy cost parameters included the physiological cost index and the VO²maximum.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Gait disorder,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 28/04/2018
Actual trial start date 30/04/2018
Anticipated date of last follow up 15/05/2018
Actual Last follow-up date 18/05/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Upper front infant carrying Once 240meter distance Walking a mapped distance of 240meters carrying the dummy at the upper front position to ascertain the effect on gait and cost of locomotion. They served as their own control too 30
Control Group Mid front infant carrying Once 240meter distance The participants are made to walk a distance of 240meters already mapped out and at the same time carrying the infant dummy anteriorly and fitted with an adjustable baby carrier such that the centre of gravity of the infant is at the level of L3 vertebrae which is the umblical level They served as their own control 30 Dose Comparison
Experimental Group Lower front infant carrying method Once 240meter distance The participants are made to walk a distance of 240meters already mapped out and at the same time carrying the infant dummy anteriorly and fitted with an adjustable baby carrier such that the centre of gravity of the infant is below level of L3 vertebrae. They served as their own control too 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Apparently healthy young females within age range 18 to 35. 2.young females who are able to understand English and Igbo languages were permitted to participate since the study directives were communicated in both languages. 3.Nulliparous non-pregnant females who have not been actively engaging in trunk loading activities like carrying infants or front packs .This was to rule out the confounding influence of survivor effect . 1.Young females with a history of neuromuscular or musculoskeletal pathologies of the spine,thorax and or lower limbs . 2.participants with limb length discrepancy and lower limb disability affecting their gait and balance . 3.young females with cardivascular diseases interfering with the heart rate Adult: 19 Year-44 Year 18 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2018 University of Nigeria teaching hospital health research ethics and committee
Ethics Committee Address
Street address City Postal code Country
University of Nigeria teaching hospital Ituku-Ozalla Enugu 400211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Walking at the normal self walking speed carrying the infant dummy placed at different positions anteriorly After a participant covers a distance of 240meters walking
Secondary Outcome Cardiorespiratory indices(heart rate ,respiratory rate and oxygen saturations rate ) just immediately the experiment is concluded
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Enugu campus College Road Enugu 400 Nigeria
University of Nigeria Enugu campus College Road Enugu state 400 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Okwor Ignatius Enyiduru house Nsukka Nigeria
Dr.Chidiebele Ojukwu University of Nigeria Enugu campus Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr.Chidiebele Ojukwu University of Nigeria Enugu campus Enugu Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Nwankwo chidimma 11/13 onwudiwe street uwani Enugu Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chisom Okwor okwor707@gmail.com 08062524629 University of Nigeria Enugu campus
City Postal code Country Position/Affiliation
Enugu Nigeria
Role Name Email Phone Street address
Public Enquiries Chidiebele Ojukwu chidiebele.ojukwu@unn.edu.ng 08039470324 University of Nigeria Enugu campus
City Postal code Country Position/Affiliation
Enugu Nigeria
Role Name Email Phone Street address
Scientific Enquiries Chidiebele Ojukwu chidiebele.ojukwu@unn.edu.ng 08039470324 University of Nigeria Enugu campus
City Postal code Country Position/Affiliation
Enugu Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information