Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281539
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : May 27, 2016
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Region Örebro County
Bräcke diakoni Rehabcenter Sfären
University Rehabilitation Institute, Republic of Slovenia
Information provided by (Responsible Party):
Integrum

Tracking Information
First Submitted Date  ICMJE October 12, 2014
First Posted Date  ICMJE November 2, 2014
Last Update Posted Date May 27, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD) [ Time Frame: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months. ]
Each patient is asked to estimate the time spent in a given level of pain (as by VAS). The WPD is the sum of the portion of time multiplied with the pain level (0 to 5). This can also be explained as weighted mean calculation. The time with a given level of pain can be estimated in minutes/hours and extrapolated to its corresponding portion from the total time. Phantom Limb pain, which is a chronic pain, is difficult to describe can not be assesst in a single point in time. That is why patients are asked to fill in the amount of time they spend in each level of pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D) [ Time Frame: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months. ]
    Questionnaires are answered before the first treatment and after the last treatment. Patients will also answer the questionnaires for a follow-up.
  • Measure the portion of patients that had a reduction of PLP with the use of visual analog scale and reduction on the "pain rating index". [ Time Frame: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months. ]
    For the Pain Rating Index (PRI), each selected word is scored from 0 (none) to 5 (Excruciating pain). The total Pain Rating Index score is obtained by summing the item scores and higher score indicates worse pain.
  • Descriptive analysis on the effect of the proposed treatment in medicaments intake [ Time Frame: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months. ]
    questionnaires compared
  • Patients having the same treatment administration will be classified in subgroups and their results compared. [ Time Frame: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months. ]
    questionnaires compared
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
Official Title  ICMJE Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
Brief Summary The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful condition affecting 70% of amputees, so as to improve these patients' quality of life.
Detailed Description

The goal of the clinical investigation is to reduce phantom limb pain (PLP), a painful condition affecting 70% of amputees, so as to improve these patients' quality of life. Traditionally, mirror box therapy and other tools based on the same concept, have been used to alleviate pain, but their efficacy varies greatly. This project targets amputees for whom other PLP treatments have failed. Various virtual environments, including virtual/augmented reality, are controlled by the patient's phantom limb using muscle (myoelectric) signals from the stump. The patient learns to reactivates areas in the brain related to motor control of the missing limb.

The medical device is non-invasive and based on surface electromyography, a standard and widely used clinical and research tool. The surface electrodes are a standard disposable electrodes widely used in clinics and hospitals for EMG and/or ECG.

  • Myoelectric amplifiers (battery operated and isolated from the power grid)
  • Data acquisition electronics
  • Personal computer
  • Standard webcam
  • Myoelectric pattern recognition (MPR) software
  • Virtual Reality (VR)
  • Augmented Reality (AR)
  • Computer game

The clinical investigation period consists of 12 sessions per patient including 3 short follow-up assessments. Length of the session: 1.5 hours (the first sessions can take longer time due to learning/familiarization). The centers participating in this study can choose between the following treatment administrations:

  • 2 times per week (advised)
  • 1 time per week
  • Daily (5 times per week)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Phantom Limb Pain
Intervention  ICMJE Device: Neuromotus
Study Arms  ICMJE Experimental: Treatment using myoelectric signals
Virtual- and augmented reality, are controlled by the patient's phantom limb using muscle (myoelectric) signals from the stump. The patient learns to reactivate areas in the brain related to motor control of the missing limb. The medical device is non-invasive and based on surface electromyography
Intervention: Device: Neuromotus
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2014)
40
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Amputee patients older than 18 years.
  • The patient has signed a written informed consent.
  • Patients must have been treated with at least one of the following therapies:

    1. Conventional mirror training
    2. Transcutaneous electrical stimulation (TENS)
    3. Acupuncture
    4. Self-hypnosis
    5. Drug-based
  • The last session of previous therapies (1 and 2) must be at least 1 month before beginning the treatment here proposed.
  • In the case of drug-based treatments (5), the patient must report no PLP reduction for at least 1 month under the drug-based treatment and no variations on the medicaments dose. Any pain reduction potentially attributed to the drug-based treatment must be at least 3 months old.
  • At least a portion of biceps and triceps muscles must be present.

Exclusion Criteria:

  • Patient must not have a significant cognitive impairment that prevents them from following instructions.
  • Upper limb amputees excluding shoulder disarticulation.
  • Obese patient will not be automatically excluded, however, an evaluation in the system is required to analyse if sufficient electromyography signals can be recorded.
  • Stump pain over 2 VAS of pain.
  • Participating in any other clinical study that could interfere with the result in the ongoing study.
  • Condition associated with risk of poor protocol compliance.
  • Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02281539
Other Study ID Numbers  ICMJE PLP-004664
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Integrum
Study Sponsor  ICMJE Integrum
Collaborators  ICMJE
  • Sahlgrenska University Hospital, Sweden
  • Region Örebro County
  • Bräcke diakoni Rehabcenter Sfären
  • University Rehabilitation Institute, Republic of Slovenia
Investigators  ICMJE
Study Chair: Rickard Brånemark, MD MSC, PhD Integrum AB
Principal Investigator: Kerstin Caine-Winterberger, OT Rehabilitation Center for Upper Limb Prosthetics, Sahlgrenska University Hospital
PRS Account Integrum
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP