PlayBionic: Interactive Mobile Training App

NCT ID: NCT03547310

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2019-04-01

Brief Summary

Often prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train. To properly control a prosthesis, amputation patients must learn how to activate, isolate and sustain nerve signals to the muscles left at the stump. Results of clinical validations show that game-based training leads to an improvement in clinical parameters for prosthesis control and patient engagement.

Detailed Description

Relevance:

Many users of a myoelectric arm prosthesis do not use their device because they find it too difficult to control the prosthesis. This may be due to the fact that patients cannot contract their muscles in the residual limb in a sufficiently controlled manner. Exactly this circumstance is trained during the physiotherapy with the patients. But at home many patients lack the motivation to continue the exercises from physiotherapy. Mobile games on the smartphone can provide patients with long-term motivation to continue the repetitive exercises that prepare the muscles for controlling a prosthesis at home.

Aim:

The aim of this study is to support patients in training at home with a game on their smartphone. This should increase motivation and improve the ability to control a prosthesis efficiently.

Design:

The Smartphone App is a rhythmic, music-based game consisting of different game modes. It has not only a display for real-time bio-feedback, but also many other audiovisually motivating incentives to continue playing the game. Similar to the classical control of a commercial prosthesis, the muscle signals are measured by two surface electrodes and, in this case, transferred to the app instead of the prosthesis. With these 2 electrodes the game is controlled. Test persons receive feedback on their performance through the constantly displayed bio-feedback, but also through high scores of the various levels and user statistics. By testing the muscle coordination twice a week, the neuromuscular improvements in the control of the game can be monitored.

Method/Procedure:

Eight transradially (below the elbow) amputated patients participate in this study. The intervention consists of playing with the smartphone training program using the muscle signals picked up by surface electrodes. The study will run over a period of 5 weeks, with participants playing with the training program at home for 4 weeks. The program should be used 5 times per week, therefore the intervention takes place 20 times in total. In the 5th week the final assessment, a final evaluation and the return of the devices take place. All usage data, such as starting and exiting the program and the duration of use, are recorded by the program itself and treated anonymously.

Conditions

Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MyoBeatz

The intervention consists of playing with the smartphone training program using the muscle signals picked up by surface electrodes. The study will run over a period of 5 weeks, with participants playing with the training program at home for 4 weeks.

Group Type: EXPERIMENTAL

MyoBeatz

Intervention Type: BEHAVIORAL

Training of the patient's muscle coordination, strength and ability to separately contract muscles, while holding up patient motivation. The patient is expected to follow a protocol of 4 weeks of training.

Interventions

MyoBeatz

Training of the patient's muscle coordination, strength and ability to separately contract muscles, while holding up patient motivation. The patient is expected to follow a protocol of 4 weeks of training.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Transradial amputees are included in the study.

Exclusion Criteria

• Exclusion criterion is the inappropriate handling of the Android tablet or the computer ,as well as cyber sickness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Cosima Prahm

MSc, BA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oskar Aszmann, Prof.

Role: STUDY_CHAIR

Medical University of Vienna

Locations

Medical University of Vienna, CD Laboratory for Restoration of Extremity Function

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Cosima Prahm, MSc, BA

Role: CONTACT

cosima.prahm@meduniwien.ac.at

004314040061098

Facility Contacts

Cosima Prahm, MSc, BA

Role: primary

cosima.prahm@meduniwien.ac.at

004314040061098

References

Prahm C, Vujaklija I, Kayali F, Purgathofer P, Aszmann OC. Game-Based Rehabilitation for Myoelectric Prosthesis Control. JMIR Serious Games. 2017 Feb 9;5(1):e3. doi: 10.2196/games.6026.

Reference Type: BACKGROUND

PMID: 28183689 (View on PubMed)

Other Identifiers

1193/2017

Identifier Type: -

Identifier Source: org_study_id