Clinical trial NCT06669871: Effects of Weight of Dress Shirt on Arthrokinematics of Cervical Spine in Healthy Females
Official title: Effects of Weight of Dress Shirts on Arthrokinematics of Cervical Spine and Shoulders in Healthy Females Using Motion Capture Analysis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Mass Index, Normal
Body Mass Index 18.5 or Greater
Keywords: Neck arthrokinematics;
Dress Shirt
Health females
Motion Capture Analysis
Lead sponsor: CMH Lahore Medical College and Institute of Dentistry
Sponsor class: OTHER
Collaborators: name: Lahore University of Management Sciences
First posted: 2024-11-01
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: arthrokinematics of cervicle spine
timeFrame: With the application of intervention Shirt-A, and at 1 week with the application of intervention Shirt-B
Secondary outcomes:
measure: recruitment of muscles on EMG
timeFrame: 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
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: School of Allied Health Sciences, CMH Lahore Medical College & Institute of Dentistry
state: Punjab
Study officials:
affiliation: CMH Lahore Medical College and Institute of Dentistry, Lahore Pakistan
name: Wajida Perveen, PhD* (PT)
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahore University of Management Sciences
name: Mian M Awais, PhD
role: STUDY_DIRECTOR
References: