Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
Primary Purpose
Phantom Limb Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neuromotus
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom Limb Pain, Augmented Reality, Myoelectric control, Virtual reality, electromyography, pattern recognition, neurorehabilitation
Eligibility Criteria
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:
- Conventional mirror training
- Transcutaneous electrical stimulation (TENS)
- Acupuncture
- Self-hypnosis
- 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.
Sites / Locations
- Rehabilitation Center for Upper Limb Prosthetics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment using myoelectric signals
Arm Description
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
Outcomes
Primary Outcome Measures
Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD)
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.
Secondary Outcome Measures
Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D)
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".
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
questionnaires compared
Patients having the same treatment administration will be classified in subgroups and their results compared.
questionnaires compared
Full Information
NCT ID
NCT02281539
First Posted
October 12, 2014
Last Updated
May 25, 2016
Sponsor
Integrum
Collaborators
Sahlgrenska University Hospital, Sweden, Region Örebro County, Bräcke diakoni Rehabcenter Sfären, University Rehabilitation Institute, Republic of Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT02281539
Brief Title
Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
Official Title
Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrum
Collaborators
Sahlgrenska University Hospital, Sweden, Region Örebro County, Bräcke diakoni Rehabcenter Sfären, University Rehabilitation Institute, Republic of Slovenia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
Phantom Limb Pain, Augmented Reality, Myoelectric control, Virtual reality, electromyography, pattern recognition, neurorehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment using myoelectric signals
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Neuromotus
Primary Outcome Measure Information:
Title
Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD)
Description
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.
Time Frame
12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.
Secondary Outcome Measure Information:
Title
Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D)
Description
Questionnaires are answered before the first treatment and after the last treatment. Patients will also answer the questionnaires for a follow-up.
Time Frame
12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.
Title
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".
Description
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.
Time Frame
12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.
Title
Descriptive analysis on the effect of the proposed treatment in medicaments intake
Description
questionnaires compared
Time Frame
12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.
Title
Patients having the same treatment administration will be classified in subgroups and their results compared.
Description
questionnaires compared
Time Frame
12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Conventional mirror training
Transcutaneous electrical stimulation (TENS)
Acupuncture
Self-hypnosis
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rickard Brånemark, MD MSC, PhD
Organizational Affiliation
Integrum AB
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kerstin Caine-Winterberger, OT
Organizational Affiliation
Rehabilitation Center for Upper Limb Prosthetics, Sahlgrenska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Center for Upper Limb Prosthetics
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24616655
Citation
Ortiz-Catalan M, Sander N, Kristoffersen MB, Hakansson B, Branemark R. Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient. Front Neurosci. 2014 Feb 25;8:24. doi: 10.3389/fnins.2014.00024. eCollection 2014.
Results Reference
result
PubMed Identifier
27916234
Citation
Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.
Results Reference
derived
Learn more about this trial
Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
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