NCT03547310

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

April 24, 2018

Last Update Submit

May 23, 2018

Conditions

Rehabilitation

Keywords

EMGProsthesis controlNeuromuscular rehabilitationGames for health

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    15 minutes

Secondary Outcomes (1)

  • Phantom limb pain

    At the beginning and at the end of the study (after 4 weeks)

Study Arms (1)

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.

Behavioral: MyoBeatz

Interventions

MyoBeatzBEHAVIORAL

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.

MyoBeatz

Eligibility Criteria

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

You may qualify if:

  • Transradial amputees are included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28183689BACKGROUND

Study Officials

  • Oskar Aszmann, Prof.

    Medical University of Vienna

    STUDY CHAIR

Central Study Contacts

Cosima Prahm, MSc, BA

CONTACT

004314040061098cosima.prahm@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, BA

Study Record Dates

First Submitted

April 24, 2018

First Posted

June 6, 2018

Study Start

April 24, 2018

Primary Completion

February 1, 2019

Study Completion

April 1, 2019

Last Updated

June 6, 2018

Record last verified: 2018-05

Locations

AU(1)