RehabilitationPlayBionicNCT03547310
PlayBionic: Interactive Mobile Training App
A study testing MyoBeatz in people with Rehabilitation, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- MyoBeatz
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- 24 Apr 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Transradial amputees are included in the study.
Who cannot join
- Exclusion criterion is the inappropriate handling of the Android tablet or the computer ,as well as cyber sickness.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, CD Laboratory for Restoration of Extremity Function
Vienna, 1090
Cosima Prahm, MSc, BA, 004314040061098, cosima.prahm@meduniwien.ac.at
About this study
Official title: PlayBionic: Interactive Mobile Training App After Nerve Transfer or Amputation of the Upper Extremity
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.
Read the 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
- Being tested
- MyoBeatz
- Keywords
- EMG, Prosthesis control, Neuromuscular rehabilitation, Games for health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoBeatzBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MyoBeatz | Experimental | 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. Receives: Behavioral: MyoBeatz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Voluntary Contraction
Testing the patients voluntary myoelectric (EMG) contraction strength, given in millivolt (mV).
This assessment is used as a calibration of the voltage detected by the electrodes. Participants are asked to maximally contract one muscle and to hold this contraction for 1.3 seconds, of which only the last second is taken for calculating the activation baseline.
Measured: 10 minutes
Precision Control
Testing the patient's ability to precisely control their muscle contraction, given in percentage of target deviation.
The Assessment of Precision Control evaluates the participant's fine EMG control accuracy. The range of this test was adapted based on the outcome of the MVC test. The participant is asked to reach 30 randomly preselected activation levels in the range of 10-90% of maximum voluntary contraction, and sustain them for 300 milliseconds each. The required level of activation is indicated by a triangular mark on the EMG bar. A total of 30 marks (3 trials consisting of 10 levels) are performed. The percentile deviation from the mark is taken as outcome measure.
Measured: 30 minutes
Endurance Control
The Assessment of Endurance Control assesses muscle coordination and muscle fatigue while the participants used their EMG signals to closely follow a sine curve o 1/4 hertz on the screen until they feel fatigued. The estimated force needed to reach the peaks of the sine curve corresponds to 60% maximum voluntary contraction. Electrode activation needs to be separate to reach the peaks of the sine curve. The minimum time to be reached in this test is 5 minutes. The outcome measure is the EMG signal deviation from the desired sine curve, given as correlation r².
Measured: 15 minutes
Secondary outcomes (1)
Phantom limb pain
Evaluation if the patient's phantom limb pain has been alleviated during or after the intervention. A questionnaire will be given that includes questions from the MPI - German version of the Multidimensional Pain Inventory. Three parts of the inventory, comprised of 12 scales, examine the impact of pain on the patients' lives, the responses of others to the patients' communications of pain, and the extent to which patients participate in common daily activities. The outcome measure is a number that will represent the pain felt by the patient
Measured: At the beginning and at the end of the study (after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start24 Apr 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cosima Prahm, Medical University of Vienna
- Investigators
- Oskar Aszmann, Prof., Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547310
- Sponsor's protocol ID
- 1193/2017
- Acronym
- PlayBionic
- Status last verified
- May 2018
- First submitted
- 24 Apr 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28183689
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PlayBionic: Interactive Mobile Training App After Nerve Transfer or Amputation of the Upper Extremity
- ClinicalTrials.gov ID
- NCT03547310
- Acronym / sponsor ID
- PlayBionic / 1193/2017
- Conditions
- Rehabilitation
- Keywords
- EMG, Prosthesis control, Neuromuscular rehabilitation, Games for health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 6 Jun 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoBeatz | Experimental | Behavioral: MyoBeatzThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Transradial amputees are included in the study.
Key exclusion criteria (1 listed)
- Exclusion criterion is the inappropriate handling of the Android tablet or the computer ,as well as cyber sickness.
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 |
|---|---|---|
| MyoBeatzTraining 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. | Behavioural | MyoBeatz |
Primary outcome
Maximum Voluntary Contraction
Time frame: 10 minutes
Testing the patients voluntary myoelectric (EMG) contraction strength, given in millivolt (mV). This assessment is used as a calibration of the voltage detected by the electrodes. Participants are asked to maximally contract one muscle and to hold this contraction for 1.3 seconds, of which only the last second is taken for calculating the activation baseline.
Precision Control
Time frame: 30 minutes
Testing the patient's ability to precisely control their muscle contraction, given in percentage of target deviation. The Assessment of Precision Control evaluates the participant's fine EMG control accuracy. The range of this test was adapted based on the outcome of the MVC test. The participant is asked to reach 30 randomly preselected activation levels in the range of 10-90% of maximum voluntary contraction, and sustain them for 300 milliseconds each. The required level of activation is indicated by a triangular mark on the EMG bar. A total of 30 marks (3 trials consisting of 10 levels) are performed. The percentile deviation from the mark is taken as outcome measure.
Endurance Control
Time frame: 15 minutes
The Assessment of Endurance Control assesses muscle coordination and muscle fatigue while the participants used their EMG signals to closely follow a sine curve o 1/4 hertz on the screen until they feel fatigued. The estimated force needed to reach the peaks of the sine curve corresponds to 60% maximum voluntary contraction. Electrode activation needs to be separate to reach the peaks of the sine curve. The minimum time to be reached in this test is 5 minutes. The outcome measure is the EMG signal deviation from the desired sine curve, given as correlation r².
1 secondary outcome
Phantom limb pain
Time frame: At the beginning and at the end of the study (after 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 28183689Prahm 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Oskar Aszmann, Prof. study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoBeatz in people with Rehabilitation, run by Medical University of Vienna at 1 site in Austria.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cosima Prahm, MSc, BA (004314040061098, cosima.prahm@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Voluntary Contraction (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547310, which also lists 1 linked publication.
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 6 Jun 2018; AzTrials last refreshed its copy on 28 Oct 2026.