Effects of Weight of Dress Shirt on Arthrokinematics of Cervical Spine in Healthy Females

NCT ID: NCT06669871

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-25

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Body Mass Index, Normal Body Mass Index 18.5 or Greater

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Two interventions; shirt A with customized design and another shirt B with simple design will be provided to the participants. Half of the participants will use shirt A, while remaining half will use Shirt B and their motion will be captured by hi speed cameras by trained engineers under the supervision of Co-PI. After one week of initial recording, they will be invited for second recording with the other design of the shirt.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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BMI-Normal

Participants with BMI 18.50-24.50 will be included

Group Type EXPERIMENTAL

Shirt-A

Intervention Type OTHER

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.

Shirt-B

Intervention Type OTHER

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.

BMI greater than 25

Participants with BMI 25 and above will be included

Group Type EXPERIMENTAL

Shirt-A

Intervention Type OTHER

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.

Shirt-B

Intervention Type OTHER

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.

Interventions

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Shirt-A

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.

Intervention Type OTHER

Shirt-B

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lahore University of Management Sciences

OTHER

Sponsor Role collaborator

CMH Lahore Medical College and Institute of Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Wajida Perveen

Associate Professor & Head of Physical Therapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wajida Perveen, PhD* (PT)

Role: PRINCIPAL_INVESTIGATOR

CMH Lahore Medical College and Institute of Dentistry, Lahore Pakistan

Mian M Awais, PhD

Role: STUDY_DIRECTOR

Lahore University of Management Sciences

Locations

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School of Allied Health Sciences, CMH Lahore Medical College & Institute of Dentistry

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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06/ERC/CMH/LMC

Identifier Type: -

Identifier Source: org_study_id

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