- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05466513
Facial Tactile Stimulation and Hamstring Flexibility
Effect of Tactile Stimulation of Facial Skin on Hamstring Flexibility in Healthy Young Males
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty-six young healthy males in the age range 20-30 years participated in the study. They were free of any musculoskeletal conditions that would affect their performance during the test procedures. Subjects were randomly divided into two groups, the experimental group (EG) and control CG) groups. After each subject was briefed about the objectives and procedure of the experiment, written informed consent was obtained. The study fully complied with the ethical standards for human research of our university review board.
The 'Sit and Reach' (SR) test in long sitting and the 'Toe touch' (TT) test in standing were performed according to previously described protocols. Before the start of each testing session of flexibility tests (SR and TT), subjects were asked to perform about 3-5 minutes of warm-up and standardized static stretching exercises focused on the lower back and hamstring muscles.
For the SR test, a strong cubic wooden box of 35 cm was placed against the wall and each subject sat on the floor mat in a long sitting position. The knees were in full extension and the soles of the shoeless feet in neutral ankle position were placed against the box. Subjects were asked to slowly reach forward towards the toes as far as possible while keeping elbows and fingers fully extended, with palms facing down. The subjects had to maintain this position for about five seconds. The distance (in centimeters) between the tips of the middle finger and a reference point on the wooden box was noted.
For the TT test, subjects had to stand upright on the wooden box with feet at hip-width apart and were instructed to bend slowly to reach towards the toes as far as possible while keeping the knees, elbows, and fingers fully extended, with palms facing backward. The subjects had to maintain this position for about five seconds. Again, the distance (in centimeters) between the tips of the middle finger and a reference point on the floor was noted.
For both the SR and the TT tests, the calculated mean recorded distance between the tips of the middle fingers and the reference point during three trials with two-minute rest intervals in-between was used as a reference value for each subject for subsequent analyzes. These mean values were termed Pretest-SR and Pretest TT, respectively. Following the baseline assessment value of the SR and TT tests, each subject of CG or EG underwent three additional trials for each test, with a two-minute interval in between the trials. SR and TT tests were performed randomly without any specific order for both groups of subjects at the same time of day and room temperature. During the two-minute interval, the CG subjects spent their time resting in the supine position with closed eyes, while the EG subjects received tactile stimulation on the facial skin in the supine position with closed eyes. The tactile stimulation to the facial skin of the EG subjects was given by one of the authors and consisted of random strokes similar to a paintbrush around the face with soft tissue paper for two minutes.
For each subject of the CG and EG, the mean distance values between the tips of the middle fingers and the reference point during three trials during the SR and TT tests were calculated, respectively. These mean values were termed Post-test-SR and Post-test-TT, respectively. For all subjects of both the CG and EG, the difference between the Post-test-SR and Pre-test-SR; and Pre-test-TT and Pre-test-TT mean values were calculated. A greater difference between the Post-test-SR and Pre-test-SR; and the Post-test-TT and Pre-test-TT mean values were considered as increased flexibility of the hamstring muscles.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- young healthy adults
Exclusion Criteria:
- Musculoskeletal disease that can affect the testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Facial tactile stimulation was applied for 2 minutes.
|
Tactile stimulation was given around the face with soft tissue paper for two minutes.
|
|
No Intervention: Control Group
No intervention was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamstring flexibility
Time Frame: 2 minutes.
|
Hamstring muscle length was measured by Sit and reach test and Toe-touch test.
|
2 minutes.
|
Collaborators and Investigators
Sponsor
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
- RRC-2013-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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