- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06669871
Effects of Weight of Dress Shirt on Arthrokinematics of Cervical Spine in Healthy Females
Effects of Weight of Dress Shirts on Arthrokinematics of Cervical Spine and Shoulders in Healthy Females Using Motion Capture Analysis: A Pilot Study
Clothing is important to cover the human body, The quality of fabric is variable and a variety of designs of the dress shirts is available. Many females use biomechanically improper dress designs particularly of the shirts. This study will help us to find the effect of dress shirt design on cervical spine and shoulder joints arthrokinematics.
This non randomized pilot clinical trial with cross over assignment will be conducted on healthy female volunteers of 18-45 years of age with a BMI 18-40. Two interventions shirt with customized design will be provided to the participants. The motion will be captured by hi speed cameras by trained engineers. After one week of initial recording, participants will be invited for second recording with the other design of the shirt.
Study Overview
Status
Intervention / Treatment
Detailed Description
Food, shelter and clothes are basic necessities of the human being. Clothing is important to cover the human body, get protected from extremes of weather, assist in one's job roles, freedom for leisure activities and for cosmetic purposes. The quality of fabric is variable and a variety of designs of the dress shirts is available. Females are about half of total population in Pakistan. Many females use biomechanically improper dress designs particularly of the shirts, which cause uneven distribution of loads to the spine and may change the angles of the individual spinal segments. This study will help us to find the effect of dress shirt design on cervical spine and shoulder joints arthrokinematics, and investigator may proceed towards designing biomechanically and ergonomically more cost effective designs in terms of mobility, energy expenditure and prevention of musculoskeletal problems. Prevention of musculoskeletal problems can have good socioeconomic impact and help in improving health outcomes in females.
This non randomized pilot clinical trial with cross over assignment will be conducted on healthy female volunteers of 18-50 years of age with a BMI 18 and above. The participants will be divided into two groups on the basis of BMI (normal and overweight). Two interventions shirt with customized design and shirt with simple design of staple Lenin fabric will be provided to the participants. Markers for motion capture will be placed on appropriate places following standard protocols. participants' motions will be captured by specific cameras by trained engineers under the supervision of Co-PI at the movement recording lab. Recording may take 5-10 minutes in one session once the participants are prepared for the procedure. After one week of initial recording, participants will be invited for second recording with the other design of the shirt. Data will be analyzed sing IBM software SPSS version 26.0. On the basis of normality of the data, parametric or non-parametric test will be selected to compute the comparative quantitative results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54810
- School of Allied Health Sciences, CMH Lahore Medical College & Institute of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18-45 years.
- BMI 18-40
Exclusion Criteria:
Females with history of cervical spine injuries. Females with history of cervical spine surgeries. Females with Congenital untreated torticollis. Females with history of shoulder complex injuries Females with recent history of tumor (spine, thorax, CA Breast, upper extremity).
Females diagnosed with osteoporosis Infection (Pulmonary and or spinal Tuberculosis). Females with Rheumatoid Arthritis. Females with Joint hyper mobility. Females unable to comply with the study protocol due to cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BMI-Normal
Participants with BMI 18.50-24.50
will be included
|
A dress shirt of a specific design will be provided to the participants, in which weight of the front side will be double than the back side.
A dress shirt of a simple design will be provided to the participants, in which weight of the front side will be equal to the back side.
|
|
Experimental: BMI greater than 25
Participants with BMI 25 and above will be included
|
A dress shirt of a specific design will be provided to the participants, in which weight of the front side will be double than the back side.
A dress shirt of a simple design will be provided to the participants, in which weight of the front side will be equal to the back side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
arthrokinematics of cervicle spine
Time Frame: With the application of intervention Shirt-A, and at 1 week with the application of intervention Shirt-B
|
craniovertebral angle will be measured.
|
With the application of intervention Shirt-A, and at 1 week with the application of intervention Shirt-B
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recruitment of muscles on EMG
Time Frame: With the application of intervention Shirt-A; adopting specific static and dynamic positions , and at 1 week with the application of intervention Shirt-B, adopting specific static and dynamic positions
|
Recruitment of specific muscles will be studied using surface Electromyography
|
With the application of intervention Shirt-A; adopting specific static and dynamic positions , and at 1 week with the application of intervention Shirt-B, adopting specific static and dynamic positions
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wajida Perveen, PhD* (PT), CMH Lahore Medical College and Institute of Dentistry, Lahore Pakistan
- Study Director: Mian M Awais, PhD, Lahore University of Management Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 06/ERC/CMH/LMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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