Thumb InjuryNCT06731972
The Impact of Using Mobile Games on Rehabilitation Outcomes in Thumb Rehabilitation
A study testing Exercises and Mobile game in people with Thumb Injury and Rehabilitation Outcome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Hand injuries and diseases are common reasons for hospital visits and lead to both functional and workforce losses, making them a persistent problem in treatment and rehabilitation approaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thumb Injury, Rehabilitation Outcome, Mobile Phone Use
- What is being tested?
- Exercises and Mobile game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65
- With sufficient communication skills
- Experiencing pain and functional impairment in the thumb (e.g., thumb fractures, tendon injuries, nerve injuries, osteoarthritis, trigger thumb, carpal tunnel syndrome, ligament injuries, soft tissue damage, etc.),
- who are willing to volunteer.
Who cannot join
- Illiteracy, lack of a smartphone, or the presence of neurological, orthopedic, or rheumatological chronic diseases in the affected limb.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırşehir Ahi Evran University
Kirşehi̇r
seher karaçam, MSc
About this study
Hand injuries and diseases are common reasons for hospital visits and lead to both functional and workforce losses, making them a persistent problem in treatment and rehabilitation approaches. Among the various functions of the hand, the thumb is of particular importance due to its large representation in the brain and its contribution to all gripping and holding functions. Loss of function in the thumb leads to a loss of at least 40% of hand skills. Therefore, restoring the thumb's original functionality is this study primary goal in rehabilitation. To achieve this goal, intensive rehabilitation is required, which cannot be fully accomplished through clinic sessions alone, as home exercises contribute significantly to this process. The low adherence of patients to home exercises has led researchers to explore various alternatives.
The aim of this study is to investigate the effect of mobile application games on rehabilitation outcomes in patients who have lost thumb function. For the pre- and post-treatment evaluations of the patients, the following assessment tools will be used: the Visual Analog Scale (VAS) for pain, the eight-shaped tape measure for edema, the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) scale for upper extremity functionality, a finger goniometer for joint range of motion, the DuruÖz Hand Index for measuring activities of daily living, and a home exercise adherence tracking form to evaluate adherence to home exercises.
Read more
As determined by this study power analysis, 38 patients with thumb injuries will be included in the study. These patients will be randomly assigned into two groups: the routine treatment group (19 patients) and the routine treatment plus mobile game group (19 patients). The routine treatment group will receive standard treatment at the Kırşehir Ahi Evran University Faculty of Physiotherapy and Rehabilitation Hand Clinic, including classical massage, stretching, functional exercises, electrical modalities, thermal agents, and home exercises. In the routine treatment plus mobile game group, in addition to the standard treatment, patients will engage in 20-30 minutes of mobile application games (e.g., Temple Run, Flappy Bird, Angry Birds) as part of their home exercise program.
Researchers hypothesize that the group receiving mobile games in addition to the standard treatment will experience a better rehabilitation process in terms of thumb functionality, pain, and edema compared to the routine treatment group, and they will reach rehabilitation goals more quickly. Additionally, mobile games will increase motivation for home exercises and improve adherence. This study will be the first to examine the use of mobile games in thumb rehabilitation and their effect on adherence to home exercises. Researchers anticipate that the results of this study will inspire both clinicians and future research, reaching a wider audience through presentations and publications.
- Conditions
- Thumb Injury, Rehabilitation Outcome, Mobile Phone Use
- Being tested
- Exercises, Mobile game
- Keywords
- Thumb, Rehabilitation, Games, Technology
- Medical subject headings
- Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Classical massage, stretching, functional exercises, electrical modalities, thermal agents, home exercises, etc., plus home exercises.
Mobile gameDevice
mobile application games (such as Temple Run, Flappy Bird, Angry Birds, etc., or games the patient is already playing) as part of their home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Routine treatment) | Active comparator | Routine treatment (classical massage, stretching, functional exercises, electrical modalities, thermal agents, home exercises, etc.) will be applied. Receives: Other: Exercises |
| Group 2 (Routine treatment + mobile game) | Experimental | The routine treatment plus mobile game group will receive routine treatment along with 20-30 minutes of mobile application games (such as Temple Run, Flappy Bird, Angry Birds, etc.) daily as part of their home exercise program. Receives: Other: Exercises; Device: Mobile game |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) Questionnaire
The Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) is a valid and reliable scale consisting of 11 questions that assess the functional status and symptoms of the upper extremity in cases of disease and injury. It is a shorter version of the original DASH. Each question has five response options (1: no difficulty, 5: unable to do). To calculate the score, at least 10 questions must be answered. The total score is calculated out of 100 points, with higher scores indicating greater levels of disability.
Measured: 1st week and 4th week
Secondary outcomes (4)
Duruöz Hand Index (DEİ)
It is an 18-item scale that assesses hand function in activities such as cooking, dressing, personal hygiene, and other daily tasks, without inquiring about pain, numbness, social life, or psychological state. The assessment takes approximately three minutes to complete. The score is calculated out of 90 points, with higher scores indicating greater limitations and difficulty in daily living activities.
Measured: 1st week and 4th week
Assessment of Range of Motion (ROM)
The most commonly used objective method for assessing joint motion in the literature is goniometric measurement, which is both valid and reliable. Although the universal goniometer is the most frequently used goniometric tool, the finger goniometer is also one of the types of goniometers. An appropriate, satisfactory, adaptable, and reliable goniometer tool should be selected based on the situation. Measuring joint motion is difficult due to the large number of joints, small area, and complex movements involved. Due to the inherent challenges of the hand, we will prefer the finger goniometer in our study and measure the active flexion and extension angles of the thumb's metacarpophalangeal and interphalangeal joints.
Measured: 1st week and 4th week
Pain Assessment
Patients' pain during night, rest, and activity will be assessed using the Visual Analog Pain Scale (VAS). The VAS is a subjective evaluation method consisting of a horizontal or vertical 10 cm straight line. It corresponds to the expressions 0: no pain, 10: extreme/unbearable pain. The patient is asked to mark a point on the line according to the severity of their pain, considering these endpoints. The distance from the marked point to 0 is measured and recorded in centimeters.
Measured: 1st week and 4th week
Assessment of Adherence to Home Exercises
Patients will be provided with a home exercise tracking chart to monitor adherence to home exercises. In this chart, the relevant boxes will be marked each day the patient performs the home exercises over a period of 3 weeks.
Measured: 1st, 2nd, 3rd and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 May 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb InjuryStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher karaçam, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731972
- Sponsor's protocol ID
- 167638
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Mobile Games on Rehabilitation Outcomes in Thumb Rehabilitation
- ClinicalTrials.gov ID
- NCT06731972
- Acronym / sponsor ID
- 167638
- Conditions
- Thumb Injury, Rehabilitation Outcome, Mobile Phone Use
- Keywords
- Thumb, Rehabilitation, Games, Technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand injuries and diseases are common reasons for hospital visits and lead to both functional and workforce losses, making them a persistent problem in treatment and rehabilitation approaches. Among the various functions of the hand, the thumb is of particular importance due to its large representation in the brain and its contribution to all gripping and holding functions. Loss of function in the thumb leads to a loss of at least 40% of hand skills. Therefore, restoring the thumb's original functionality is this study primary goal in rehabilitation. To achieve this goal, intensive rehabilitation is required, which cannot be fully accomplished through clinic sessions alone, as home exercises contribute significantly to this process. The low adherence of patients to home exercises has led researchers to explore various alternatives.
The aim of this study is to investigate the effect of mobile application games on rehabilitation outcomes in patients who have lost thumb function. For the pre- and post-treatment evaluations of the patients, the following assessment tools will be used: the Visual Analog Scale (VAS) for pain, the eight-shaped tape measure for edema, the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) scale for upper extremity functionality, a finger goniometer for joint range of motion, the DuruÖz Hand Index for measuring activities of daily living, and a home exercise adherence tracking form to evaluate adherence to home exercises.
As determined by this study power analysis, 38 patients with thumb injuries will be included in the study. These patients will be randomly assigned into two groups: the routine treatment group (19 patients) and the routine treatment plus mobile game group (19 patients). The routine treatment group will receive standard treatment at the Kırşehir Ahi Evran University Faculty of Physiotherapy and Rehabilitation Hand Clinic, including classical massage, stretching, functional exercises, electrical modalities, thermal agents, and home exercises. In the routine treatment plus mobile game group, in addition to the standard treatment, patients will engage in 20-30 minutes of mobile application games (e.g., Temple Run, Flappy Bird, Angry Birds) as part of their home exercise program.
Researchers hypothesize that the group receiving mobile games in addition to the standard treatment will experience a better rehabilitation process in terms of thumb functionality, pain, and edema compared to the routine treatment group, and they will reach rehabilitation goals more quickly. Additionally, mobile games will increase motivation for home exercises and improve adherence. This study will be the first to examine the use of mobile games in thumb rehabilitation and their effect on adherence to home exercises. Researchers anticipate that the results of this study will inspire both clinicians and future research, reaching a wider audience through presentations and publications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Routine treatment) | Active comparator | Other: ExercisesRoutine treatment (classical massage, stretching, functional exercises, electrical modalities, thermal agents, home exercises, etc.) will be applied. |
| Group 2 (Routine treatment + mobile game) | Experimental | Other: Exercises, Device: Mobile gameThe routine treatment plus mobile game group will receive routine treatment along with 20-30 minutes of mobile application games (such as Temple Run, Flappy Bird, Angry Birds, etc.) daily as part of their home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65
- With sufficient communication skills
- Experiencing pain and functional impairment in the thumb (e.g., thumb fractures, tendon injuries, nerve injuries, osteoarthritis, trigger thumb, carpal tunnel syndrome, ligament injuries, soft tissue damage, etc.),
- who are willing to volunteer.
Key exclusion criteria (1 listed)
- Illiteracy, lack of a smartphone, or the presence of neurological, orthopedic, or rheumatological chronic diseases in the affected limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisesClassical massage, stretching, functional exercises, electrical modalities, thermal agents, home exercises, etc., plus home exercises. | Other | Group 1 (Routine treatment), Group 2 (Routine treatment + mobile game) |
| Mobile gamemobile application games (such as Temple Run, Flappy Bird, Angry Birds, etc., or games the patient is already playing) as part of their home exercise program. | Device | Group 2 (Routine treatment + mobile game) |
Primary outcome
The Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) Questionnaire
Time frame: 1st week and 4th week
The Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) is a valid and reliable scale consisting of 11 questions that assess the functional status and symptoms of the upper extremity in cases of disease and injury. It is a shorter version of the original DASH. Each question has five response options (1: no difficulty, 5: unable to do). To calculate the score, at least 10 questions must be answered. The total score is calculated out of 100 points, with higher scores indicating greater levels of disability.
4 secondary outcomes
Duruöz Hand Index (DEİ)
Time frame: 1st week and 4th week
Assessment of Range of Motion (ROM)
Time frame: 1st week and 4th week
Pain Assessment
Time frame: 1st week and 4th week
Assessment of Adherence to Home Exercises
Time frame: 1st, 2nd, 3rd and 4th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises and Mobile game in people with Thumb Injury and Rehabilitation Outcome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher Karaçam, MSc (05392031872, seher.dursun@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) Questionnaire (time frame: 1st week and 4th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.