NCT06731972

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 2, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

ThumbRehabilitationGamesTechnology

Outcome Measures

Primary Outcomes (1)

  • 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.

    1st week and 4th week

Secondary Outcomes (4)

  • Duruöz Hand Index (DEİ)

    1st week and 4th week

  • Assessment of Range of Motion (ROM)

    1st week and 4th week

  • Pain Assessment

    1st week and 4th week

  • Assessment of Adherence to Home Exercises

    1st, 2nd, 3rd and 4th week

Other Outcomes (1)

  • Case Follow-up Form

    1st week

Study Arms (2)

Group 1 (Routine treatment)

ACTIVE COMPARATOR

Routine treatment (classical massage, stretching, functional exercises, electrical modalities, thermal agents, home exercises, etc.) will be applied.

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.

Other: ExercisesDevice: Mobile game

Interventions

Classical massage, stretching, functional exercises, electrical modalities, thermal agents, home exercises, etc., plus home exercises.

Group 1 (Routine treatment)Group 2 (Routine treatment + mobile game)

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.

Group 2 (Routine treatment + mobile game)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Illiteracy, lack of a smartphone, or the presence of neurological, orthopedic, or rheumatological chronic diseases in the affected limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kirşehi̇r, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cell Phone Use

Interventions

Exercise

Condition Hierarchy (Ancestors)

CommunicationBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Seher Karaçam, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, MSc., Physiotherapist

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 13, 2024

Study Start

May 15, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations