Clinical trial NCT03547310: PlayBionic: Interactive Mobile Training App
Official title: PlayBionic: Interactive Mobile Training App After Nerve Transfer or Amputation of the Upper Extremity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Keywords: EMG
Prosthesis control
Neuromuscular rehabilitation
Games for health
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum Voluntary Contraction
timeFrame: 10 minutes
measure: Precision Control
timeFrame: 30 minutes
measure: Endurance Control
timeFrame: 15 minutes
Secondary outcomes:
measure: Phantom limb pain
timeFrame: At the beginning and at the end of the study (after 4 weeks)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, CD Laboratory for Restoration of Extremity Function
Study officials:
affiliation: Medical University of Vienna
name: Oskar Aszmann, Prof.
role: STUDY_CHAIR
References:
citation: 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.