## Protocol Section
### Identification Module
**NCT ID:** NCT06417970

**Brief Title:** Proprioception, Touch and Psychometric Relationship in Volleyball Players

**Official Title:** The Relationship Between Shoulder Proprioception, Palmar Touch Sensation and Psychometric Parameters in Volleyball Players

#### Organization Study ID Info
**ID:** Voleybolcu Omuz
#### Organization
**Class:** OTHER
**Full Name:** Suleyman Demirel University
### Status Module
#### Completion Date
**Date:** 2024-05-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-17

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Suleyman Demirel University

#### Responsible Party

**Investigator Affiliation:** Suleyman Demirel University

**Investigator Full Name:** Ramazan Kursat Erdas

**Investigator Title:** Dr

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Improvement of proprioception in athletes has been found to be effective in preventing fear of movement. The importance of these parameters has not been sufficiently emphasized in volleyball players. In addition, the relationship between upper extremity proprioception and the sense of touch, which is an important component of the somatosensory system, and common anxiety states in athletes has not been evaluated. Therefore, the aim of our study was to investigate the relationship between shoulder joint proprioception and psychometric parameters, kinesiophobia and palmar tactile sensation in volleyball players.

**Detailed Description:** The study will not include any intervention program. Volleyball players who are volleyball players in their school team and volleyball players who apply to the Sports Medicine Polyclinic with a general health examination or lower extremity injury complaint will be invited to the study. Volleyball players between the ages of 18-30, who meet the inclusion criteria and consent to participate will be included in the study. At the beginning, the participants will be informed and if they volunteer, they will sign an informed consent form. The demographic data of the participants will be filled in on a form prepared by the researchers.

The parameters to be evaluated during the study are glenohumeral joint proprioception measurements (internal rotation, external rotation), Athlete Psychological Strain Questionnaire, Tampa Kinesiophobia Questionnaire and palmar tactile sensation measurement with Semmes-Weinstein Monofilament.

Glenohumeral joint proprioception measurements: Visual input is eliminated with a blindfold while the participant is in a seated position with the arm in 90° abduction and elbow in 90° flexion. The measurement reference angles are 30° and 60°. The upper extremity will be moved passively from the neutral position in the direction of internal and external rotation up to the reference angle. It will be held at the reference angle for 10 seconds and then passively moved back to the neutral position. The speed of the dynamometer will be set to 0.5°/s. The participant will then be instructed to repeat the position in which the upper limb was previously placed, taking into account the reference angle. After the learning trial, the average of the absolute error of the three test trials will be recorded as the position sense test result.

Athlete Psychological Strain Questionnaire: This questionnaire will be used to measure sport-specific psychological tension. It consists of 10 items and each item is scored on a 5-point Likert scale (1=never to 5=always) and assesses self-regulation (e.g. "I felt less motivated"), performance (e.g. "I found training more stressful") and external coping (e.g. "I took unusual risks off the field"). The minimum score is 10, while the maximum score is 50. Higher scores indicate greater psychological strain.

Tampa kinesiophobia questionnaire: This questionnaire measures fear of movement/reinjury. It consists of 17 items and the normal score range is between 17 and 68. A lower score indicates a better condition.

Palmar tactile sensation: Palmar tactile sensation will be measured with the Semmes-Weinstein Monofilament. The tested hand will be placed on a towel and hidden behind a screen with the forearm supinated. Monofilaments will be placed in contact with the tip of the thumb (median nerve), the tip of the little finger (ulnar nerve) and between the index finger and thumb on the dorsal side of the hand (radial nerve). Patients will be asked to verbally answer "Yes" when they feel touched by the monofilaments. The monofilament will be applied perpendicular to the skin until it is slightly bent for 1.5 seconds. The measurement time (approach, pressure and withdrawal of the monofilament) will not exceed 3 seconds and the test will start with the thinnest monofilament (lowest pressure) and end when at least 1 positive response is collected from 3 trials.

The power analysis of the study was performed with the program GPower 3.1.9.7 (Universitaet Kiel, Germany). In the study, the correlation value between the Y-Balance Test Inferolateral and Internal Rotation Active Joint Position Sensation measurements calculated in Mendez-Rebolledo et al. (2022), r=-0.57, was used. Accordingly, test family "Exact" and analysis type "Correlation: Bivariate normal model" were selected. The explanatory coefficient R2=0.33 and the alternative hypothesis effect size was calculated as 0.574. The sample size was determined as n=33 with a two-way table value, 95% power and 5% type-I margin of error.

### Conditions Module

**Conditions:**

- Proprioceptive Disorders

- Sports Physical Therapy

- Kinesiophobia

- Somatosensory Disorders

- Shoulder Injuries

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 33

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Shoulder Proprioception, Palmar Touch Sensation and Psychometric Parameters

**Label:** Volleyball Players

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Volleyball Players

**Description:** Shoulder Proprioception: Proprioception will be measured with isokinetic device. The measurement reference angles are 30° and 60°.

Palmar Touch Sensation: Palmar tactile sensation will be measured with the Semmes-Weinstein Monofilament.

Psychometric Parameters: Athlete Psychological Strain Questionnaire, Tampa kinesiophobia questionnaire

**Name:** Shoulder Proprioception, Palmar Touch Sensation and Psychometric Parameters

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Visual input is eliminated with a blindfold while the participant is in a seated position with the arm in 90° abduction and elbow in 90° flexion. The measurement reference angles are 30° and 60°. The upper extremity will be moved passively from the neutral position in the direction of internal and external rotation up to the reference angle. It will be held at the reference angle for 10 seconds and then passively moved back to the neutral position. The speed of the dynamometer will be set to 0.5°/s. The participant will then be instructed to repeat the position in which the upper limb was previously placed, taking into account the reference angle. After the learning trial, the average of the absolute error of the three test trials will be recorded as the position sense test result.

**Measure:** Glenohumeral joint proprioception measurement

**Time Frame:** Change from Baseline glenohumeral joint proprioception measurement at first day

**Description:** This questionnaire will be used to measure sport-specific psychological tension. It consists of 10 items and each item is scored on a 5-point Likert scale (1=never to 5=always) and assesses self-regulation (e.g. "I felt less motivated"), performance (e.g. "I found training more stressful") and external coping (e.g. "I took unusual risks off the field"). The minimum score is 10, while the maximum score is 50. Higher scores indicate greater psychological strain.

**Measure:** Athlete Psychological Strain Questionnaire

**Time Frame:** Change from Baseline Athlete Psychological Strain Questionnaire at first day

**Description:** This questionnaire measures fear of movement/reinjury. It consists of 17 items and the normal score range is between 17 and 68. A lower score indicates a better condition.

**Measure:** Tampa kinesiophobia questionnaire

**Time Frame:** Change from Baseline Tampa kinesiophobia questionnaire at first day

**Description:** Palmar tactile sensation will be measured with the Semmes-Weinstein Monofilament. The tested hand will be placed on a towel and hidden behind a screen with the forearm supinated. Monofilaments will be placed in contact with the tip of the thumb (median nerve), the tip of the little finger (ulnar nerve) and between the index finger and thumb on the dorsal side of the hand (radial nerve). Patients will be asked to verbally answer "Yes" when they feel touched by the monofilaments. The monofilament will be applied perpendicular to the skin until it is slightly bent for 1.5 seconds. The measurement time (approach, pressure and withdrawal of the monofilament) will not exceed 3 seconds and the test will start with the thinnest monofilament (lowest pressure) and end when at least 1 positive response is collected from 3 trials.

**Measure:** Palmar tactile sensation

**Time Frame:** Change from Baseline palmar tactile sensation at first day

#### Secondary Outcomes

**Description:** Whether the athlete is healthy or not, age, gender, height, weight, history of upper extremity injuries, presence of chronic diseases, sport position, weekly training frequency, how long he/she has been playing volleyball, dominant side, shoulder range of motion will be recorded.

**Measure:** Demographic data

**Time Frame:** Change from Baseline demographic data at first day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Being between 18-30 years old
* Being a sub-elite level volleyball player (school team / student athlete)
* Regular volleyball training (at least once a week)
* No history of upper extremity injury in the last 1 year

Exclusion Criteria:

* Having undergone a surgery involving the upper extremity
* Any orthopedic problems that may affect the assessments
* Not giving consent to participate in the study

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** Healthy volleyball athlete

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Isparta

**Country:** Turkey

**Facility:** Süleyman Demirel University Faculty of Medicine, Clinic of Sports Medicine

#### Overall Officials

**Official 1:**

**Affiliation:** Süleyman Demirel University

**Name:** Ferdi Başkurt, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Süleyman Demirel University

**Name:** Sabriye Ercan, PhD

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Süleyman Demirel University

**Name:** Elif Şahin, MSc

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Süleyman Demirel University

**Name:** İsmet Tümtürk, MSc

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** Süleyman Demirel University

**Name:** Ramazan Kürşat Erdaş, MD

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** Süleyman Demirel University

**Name:** Fatih Uğur Taş, MD

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** Süleyman Demirel University

**Name:** Furkan Hasan Küçük, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010698

- Term: Phobic Disorders

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M2922

- Name: Kinesiophobia

- Relevance: HIGH

- As Found: Kinesiophobia

- ID: M22625

- Name: Somatosensory Disorders

- Relevance: HIGH

- As Found: Somatosensory Disorders

- ID: M602

- Name: Shoulder Injuries

- Relevance: HIGH

- As Found: Shoulder Injuries

- ID: M13603

- Name: Phobic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020886

- Term: Somatosensory Disorders

- ID: D000070599

- Term: Shoulder Injuries

- ID: D000092442

- Term: Kinesiophobia

### Misc Info Module

- Version Holder: 2024-05-31
