NCT06602401

Brief Summary

The goal of this cross-sectional study is to investigate the relationships between grip/pinch strengths, wrist flexion-extension strengths, wrist proprioception, manual dexterity, and bimanual coordination in healthy volunteers. The hypotheses are: H0: There is no relationship between grip/pinch strengths, wrist flexion-extension strengths, wrist proprioception, manual dexterity, and bimanual coordination. H1: There is a relationship between grip/pinch strengths, wrist flexion-extension strengths, wrist proprioception, manual dexterity, and bimanual coordination. Within the scope of the study, the participants' active joint position sense (AJPS) and flexion-extension strengths of the wrist were assessed using an isokinetic dynamometer. Additionally, grip strength, key pinch, tip pinch, and palmar pinch strengths were evaluated using a dynamometer. The Purdue Pegboard Test was used to assess manual dexterity and bimanual coordination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

September 17, 2024

Last Update Submit

September 17, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • The Purdue Pegboard Test was used to assess bimanual coordination.

    In the Purdue Pegboard test, participants, seated in front of the test board, were asked to placed pins into the holes on both sides of the board simultaneously with both hands as many pins as possible within 30 seconds. The total number of pins placed was recorded as the score for bimanual coordination.

    Participants will be evaluated only once.

  • The Purdue Pegboard Test was used to assess manual dexterity.

    In the Purdue Pegboard test, participants, seated in front of the test board, were first asked to use their dominant hand to pick up pins from the dominant side and place them into the holes on the same side, from top to bottom. They were instructed to place as many pins as possible within 30 seconds. The number of pins placed was recorded as the score for dominant hand manual dexterity. The same test was then conducted for the nondominant side.

    Participants will be evaluated only once.

  • The active joint position sense was assessed using an isokinetic dynamometer.

    For the assessment of wrist proprioception, an isokinetic dynamometer with demonstrated reliability \[Cybex NORM®, Humac, CA, USA\] was used. Wrist proprioception was assessed by Active Joint Position Sense (AJPS) measurement. During the test, participants wore eye masks. For the AJPS assessment, the target angle was set at 30° extension, which is the functional position of the wrist. Participants were asked to actively move their wrist from the neutral position to the 30° extension and hold this position for 5 seconds. This trial was repeated three times. Participants were then asked to find the target angle three times. The amount of error between the target angle and the achieved angle was used to define the accuracy of the active joint position sense. The arithmetic mean of these three measurements was calculated and recorded.

    Participants will be evaluated only once.

  • The flexion-extension strengths of the wrist were assessed using an isokinetic dynamometer.

    Wrist flexion and extension strengths were also evaluated using the Cybex isokinetic dynamometer. These strength assessments were conducted in the same position and range of motion as the proprioception evaluations. Before starting the measurements, participants were informed about the test. At the beginning of the test, three practice trials were performed. The concentric-concentric strength measurement was conducted with an angular velocity of 60°/s for 5 repetitions. A 20-second rest period was allowed between the practice and test trials. The peak torque parameters for wrist flexion and extension in both wrists were measured. Assessments began with the dominant side. Subsequently, the same measurements were repeated on the other extremity by adjusting the position of the dynamometer and chair. The device was calibrated before the participants were evaluated. All measurements were conducted by the same person to prevent inter-rater variability.

    Participants will be evaluated only once.

  • Grip and pinch strengths were measured using a digital dynamometer.

    The assessment of gross grip strength was performed using a digital dynamometer (J-Tech Commender Grip Track). Measurements were taken with the participant seated, the elbow flexed at 90 degrees, the wrist in up to 30 degrees of extension, and the forearm in a neutral rotation position. The dynamometer's grip width was set to the second level. Maximum grip force was measured by having the participant squeeze as hard as possible three times, and the arithmetic mean of these three measurements was calculated. Key pinch, palmar pinch, and tip pinch strength measurements were conducted using a pinch gauge (Baseline Mechanical Pinch Gauge, 60 lb) in the same position and with the same measurement technique as the gross grip strength assessment. All evaluation protocols were established according to the recommendations of the American Society of Hand Therapists.

    Participants will be evaluated only once.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

No specific age or disease/injury group is targeted. The study was conducted with healthy volunteers.

You may qualify if:

  • After providing detailed information about the research, individuals who agreed to participate were included in the study.

You may not qualify if:

  • Individuals who had undergone surgery or trauma in the upper extremity, had fractures or acute orthopedic injuries, had a history of neuromuscular diseases or congenital anomalies, had skin infections, or other conditions that could affect the assessment within the past 6 months were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barış SEVEN

Izmir, Çiğli, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. research assistant

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

April 12, 2023

Primary Completion

January 12, 2024

Study Completion

January 12, 2024

Last Updated

September 19, 2024

Record last verified: 2024-08

Locations