NCT06669871

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

October 31, 2024

Last Update Submit

June 3, 2025

Conditions

Keywords

Neck arthrokinematics;Dress ShirtHealth femalesMotion Capture Analysis

Outcome Measures

Primary Outcomes (1)

  • arthrokinematics of cervicle spine

    craniovertebral angle will be measured.

    With the application of intervention Shirt-A, and at 1 week with the application of intervention Shirt-B

Secondary Outcomes (1)

  • recruitment of muscles on EMG

    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

Study Arms (2)

BMI-Normal

EXPERIMENTAL

Participants with BMI 18.50-24.50 will be included

Other: Shirt-AOther: Shirt-B

BMI greater than 25

EXPERIMENTAL

Participants with BMI 25 and above will be included

Other: Shirt-AOther: Shirt-B

Interventions

Shirt-AOTHER

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.

BMI greater than 25BMI-Normal
Shirt-BOTHER

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 25BMI-Normal

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale Health volunteers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-45 years.
  • BMI 18-40

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lahore, Punjab Province, 54810, Pakistan

Location

Study Officials

  • Wajida Perveen, PhD* (PT)

    CMH Lahore Medical College and Institute of Dentistry, Lahore Pakistan

    PRINCIPAL INVESTIGATOR
  • Mian M Awais, PhD

    Lahore University of Management Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Head of Physical Therapy Department

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 1, 2024

Study Start

December 25, 2024

Primary Completion

April 28, 2025

Study Completion

May 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

only outcome specific data may be shared on reasonable request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
after completion of project and dissemination of the findings as research articles or conference papers.
Access Criteria
specific data may be shared on reasonable request to Principal Investigator.

Locations