| CTRI Number |
CTRI/2024/03/064447 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Manual Therapy and Exercise Therapy on Kyphotic Posture of Breastfeeding Females |
|
Scientific Title of Study
|
Comparison of Thoracic Joint Mobilization Along With Breathing Exercises and Scapular Stabilization Exercises Along With Pectoral Muscles Stretching Exercises in Kyphotic Postpartum Females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Sharma |
| Designation |
Research Scholar |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Health center GJUST Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
7015955736 |
| Fax |
|
| Email |
preeti.vashisth03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalindi Dev |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
GJUST Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
09996323938 |
| Fax |
|
| Email |
kalindiphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalindi Dev |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
09996323938 |
| Fax |
|
| Email |
kalindiphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001 |
|
|
Primary Sponsor
|
| Name |
Preeti Sharma |
| Address |
Department of Physiotherapy,GJUST, Hisar 125001, Haryana, India |
| Type of Sponsor |
Other [Self Funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalindi Dev |
Guru Jambheshwar University of Science and technology |
Department of Physiotherapy,GJUST, Hisar 125001, Haryana, India
Hisar
HARYANA |
09996323938
kalindiphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Department of Physiotherapy GJUST Hisar Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A |
Thoracic joint mobilization along with breathing exercises thrice a week for total 4 weeks |
| Intervention |
Group B |
Scapular stabilization exercises along with pectoral muscles stretching exercises thrice a week for total 4 weeks |
| Comparator Agent |
Group C |
Postural correction advice and back strengthening exercises thrice a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal females who have been breastfeeding for a duration of 6 months to 2 years
Females with thoracic kyphosis angle greater than 40 degree |
|
| ExclusionCriteria |
| Details |
Any associated pre-existing history of musculoskeletal pain in thoracic region
Any associated orthopedic problem such as presence of scoliosis history of spinal fracture spinal tumors rheumatoid arthritis congenital spinal abnormalities
Any associated neurological problems like significant cognitive defects etc
Any psychological disorders
Uncooperative subjects who not willing to participate in the research
Unable to perform exercises |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cobb angle
Pulmonary function test
Oxygen saturation
Interscapular distance
Interscapular pain
Postnatal depression |
Baseline
4th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Exclusive breastfeeding is defined by WHO and UNICEF as supplying a baby with exclusively human milk for the first six months of life and continuing this practice while supplementing the baby’s nutrition for the remaining two years after birth. Only 35% of infants worldwide are exclusively breastfed between birth and age 5 months, according to WHO estimates. Only 46% of Indian newborns between the ages of 0 and 6 months are exclusively breastfed, according to the national family survey-3 (NFHS-3). The average nursing session lasts between 15-20 minutes, is completed every two to three hours, and occurs 8 to 12 times a day. While breastfeeding, a mother takes a variety of postures or positions for extended periods of time, which can change the spine’s natural curvature and result in a number of postural abnormalities. Postnatal females are more likely to experience mechanical neck discomfort, carpal tunnel syndrome, kyphosis, scoliosis, sciatica, and low back pain. Trunk flexion is a abnormal posture assumed during breastfeeding that may be one of the causes of hyper kyphosis, was among the most common posture habits (66.7%). Thoracic kyphosis is the anteroposterior curve of the thoracic spine in the sagittal plane. The normal range of kyphosis is between 20 and 40 degrees, while severe forward curvature of the thoracic spine is often greater than 40 degrees is defined as hyper kyphosis. The prevalence of this abnormality was 15% in 11-year-old children and 38% in 20–50-year-old people. Kyphosis may occur in young age groups due to changes in lifestyle that are causing people to engage in less physical activity and spend a significant amount of time in sitting with a severe flexion posture. Breastfeeding mothers are more likely to develop hyper kyphosis because they adopt this flexion position for a prolonged period of time to care for and feed their infants several times throughout the day. The respiratory function parameters are impacted by kyphotic posture. In India, the majority of women feed for at least a year, and if this breastfeeding is done while maintaining poor posture for such a long time, it may result in increasing scapular muscle weakening. Therefore it become essential to explore the easiest or simple ways for the mothers of managing problems associated to postural hyper-kyphosis. Participants of postural hyper kyphosis will be screened on the basis of inclusion and exclusion criteria and will be randomized into 3 groups. Informed consent will be taken for the participation in the study. The outcomes measure will be evaluated at Baseline, at 4th week (at the end of treatment protocol).
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