Status:
COMPLETED
Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
Lead Sponsor:
Integrum
Collaborating Sponsors:
Sahlgrenska University Hospital
Region Örebro County
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02281539
Start Date
September 1 2014
End Date
January 1 2016
Last Update
May 27 2016
Active Locations (1)
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1
Rehabilitation Center for Upper Limb Prosthetics
Gothenburg, Sweden