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

NCT02281539 | Completed

• 1 other identifier: PLP-004664
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Keywords

Phantom Limb Pain; Augmented Reality; Myoelectric control; Virtual reality; electromyography; pattern recognition; neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Secondary Outcomes (4)

• Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D)

  12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

• 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".

  12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

• Descriptive analysis on the effect of the proposed treatment in medicaments intake

  12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

• Patients having the same treatment administration will be classified in subgroups and their results compared.

  12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Study Arms (1)

Treatment using myoelectric signals

EXPERIMENTAL

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

Device: Neuromotus

Interventions

Neuromotus DEVICE

Treatment using myoelectric signals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrum: lead
• Sahlgrenska University Hospital: collaborator
• Region Örebro County: collaborator
• Bräcke diakoni Rehabcenter Sfären: collaborator
• University Rehabilitation Institute, Republic of Slovenia: collaborator

Study Sites (1)

Rehabilitation Center for Upper Limb Prosthetics

Gothenburg, Sweden

Location

Related Publications (2)

• 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.

  PMID: 24616655 RESULT

• 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.

  PMID: 27916234 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Rickard Brånemark, MD MSC, PhD

  Integrum AB

  STUDY CHAIR

• Kerstin Caine-Winterberger, OT

  Rehabilitation Center for Upper Limb Prosthetics, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2014
• First Posted: November 3, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

SE (1)