The Effects of Game-Based Exercises on Upper Extremity

April 5, 2024 updated by: KTO Karatay University

The Effects of Game-Based Exercises on Upper Extremity Muscle Strength, Sensory and Functionality: A Randomized Controlled Study

The aim of this research is to investigate the impact of game-based exercises on upper extremity muscle strength, sensory perception, and functionality in adult individuals. The focus lies in measuring and assessing the effects of these exercises on this particular group. The goal is to determine the potential benefits of game-based exercises concerning upper extremity muscle strength, sensory perception, and overall functionality in adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study focuses on exploring how game-based exercises affect upper extremity muscle strength, sensory perception, and functionality in adults. It addresses the potential impact of these exercises on physical activity levels, sensory development, and body awareness. The research highlights the significance of physical engagement, particularly in digitally inactive environments, emphasizing the need for supportive physical activity interventions. Additionally, it delves into the intricate hand movements and functions related to grasping activities, emphasizing the importance of sensory perceptions in these processes. Ultimately, the study aims to understand the correlation between game-based exercises and various facets of upper extremity functionality in adults.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Konya, Turkey, 42020
        • KTO Karatay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The inclusion criteria comprise participants aged between 18 and 25 years, having good overall health with no significant upper extremity issues.
  • Participants should demonstrate active use of both hands.
  • Preference is given to individuals who have not previously engaged in regular upper extremity-focused exercises or do not have a habit of regular exercise.
  • Voluntary participation in the study and willingness to comply with program requirements are necessary.

Exclusion Criteria:

  • Encompass individuals with significant upper extremity disorders or a history of serious - hand, arm, or shoulder injuries,
  • Those with sensory impairments,
  • Individuals whose health conditions deem them unsuitable for participation in the exercise program,
  • Individuals outside the specified age range,
  • Participants who have previously engaged in upper extremity-focused exercise or similar studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No intervention will be applied to the control group
Experimental: Game-Based Exercises
The participants will engage in game-based exercise training twice a week for a total of 6 weeks. Each session will last for 45 minutes, and to ensure participants' sustained engagement, the activities will vary weekly. Here's an outline of the weekly activities:
Other: Game-Based Exercises
Week 1: Dough Kneading, Sorting Legumes, Cutting Lines with Scissors, Coloring with Dry Crayons Week 2: Dough Rolling, Scissor Use, Crumpling Paper, Finger Exercises, Tying Knots with Rubber Bands Week 3: Dough Cutting, Dough Rolling, Dough Stretching, Sewing with Needles, Wrapping Thread like a Spool, Sorting Legumes, Untying Knots in String Week 4: Rhythm Exercises, Dough Kneading and Rolling, Scissor Use, Sorting Legumes, Untying Knots in String Week 5: Stringing Beads on Thread, Unlocking, Tearing Paper, Sorting Legumes, Untying Knots in String Week 6: Tying Shoe Laces, Opening-Closing Jar Lids, Sorting Legumes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hand Muscle Strength Assessment
Time Frame: Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6
Hand muscle strength will be evaluated with the Jamar Hand Dynamometer. The unit of measurement for evaluations is kilogram-force.
Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6
Finger Muscle Strength Assessment
Time Frame: Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6
Pinch force will be measured with Jamar Hydraulic Pinchmeter. The unit of measurement for evaluations is kilogram-force.
Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensory Assessment
Time Frame: Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6
Sensory Assessment will be evaluated by two-point discrimination test. The unit of measurement for evaluations is milimeter.
Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6
Functional Assessment
Time Frame: Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6
Functional assessment will be evaluated with the Nine Hole Peg Test. The unit of measurement for evaluations is seconds.
Baseline measurement before the Gamed-Based Exercises begin (pre-intervention), post-intervention at week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KTO Karatay University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: EMİNE ARSLAN KILIÇOĞLU, PhD(c), KTO Karatay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KARATAY_EAK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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