Primary objective: Assess the efficacy of Phantom Motor Execution (PME) aided by Myoelectric Pattern Recognition (MPR), Augmented and Virtual Reality (AR-VR), and Serious Gaming (SG) to reduce Phantom Limb Pain (PLP). Secondary objective: Assess the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fantoompijn na een amputatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Changes in PLP will be measured in terms of differences between the
Pain Rating Index registered at the beginning (1st session) and at the end of
the treatment (15th session).
Secondary outcome
Secondary: The effects of the treatment will be measured as changes in the PDI
measures at the beginning (1st session) and at the end of the treatment (15th
session).
Background summary
Phantom Motor Execution restores brain changes related to the loss of a limb
and by doing so alleviates Phantom Limb Pain, which is believed to be
maintained by such changes.
Study objective
Primary objective: Assess the efficacy of Phantom Motor Execution (PME) aided
by Myoelectric Pattern Recognition (MPR), Augmented and Virtual Reality
(AR-VR), and Serious Gaming (SG) to reduce Phantom Limb Pain (PLP).
Secondary objective: Assess the effects of the proposed treatment in terms of
disability associated with pain as evaluated by the Pain Disability Index
(PDI).
Study design
International, multicentre, double-blind, randomized, controlled, clinical
trial.
Intervention
Experimental treatment: Phantom Motor Execution (PME) aided via MPR/AR-VR/SG
(Myoelectric Pattern Recognition/Augmented Reality-Virtual Reality/Serious
Gaming). Referred in the text as PME only.
Control treatment: Phantom Motor Imagery (PMI) aided via MPR/AR-VR/SG. Referred
in the text as PMI only.
Study burden and risks
Patients will have 15 treatment sessions of maximally 2 hours. Treatment is
executed using the Neuromotus system. This system has been used in regular
patient care for more than two years already. A risk analysis has been carried
out and it was concluded that this is a low-risk treatment. The benefit of the
system is higher than all the risks in using the system.
There will be 3 follow-up sessions after the last treatment session. During the
follow-up sessions questions and questionnaires have to be answered.
Maskingränd 2 50
Gothenburg SE-412 96
SE
Maskingränd 2 50
Gothenburg SE-412 96
SE
Listed location countries
Age
Inclusion criteria
Subject must be older than 18 years, must have an acquired amputation of upper or lower limb.
• If the subjects are under pharmacological treatments, there must be no variations on the medicament dosages for at least one month (steady consumption).
• The last session of previous treatments must be at least 3 months old.
• Any pain reduction potentially attributed to previous PLP treatments must be at least 3 months old.
• Subjects must have control over at least a portion of biceps and triceps muscles for upper limb amputations, and quadriceps and hamstrings for the lower limb amputations.
• The subject has signed a written informed consent.
• The subject must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis) or being a nonuser.
• At least six months should be passed since the amputation: acute PLP cases should not be included in the study.
• The patient subject should not have a significant cognitive impairment that prevents the patient from following instructions.
• Subjects with abundant soft tissue on their stump will not be automatically excluded, however, an evaluation in the system is required to analyze if sufficient electromyography signals can be recorded.
Exclusion criteria
• The subject should not have any condition associated with risk of poor protocol compliance.
• The subject should not have any other condition or symptoms preventing the patient from entering the study, according to the investigator*s judgment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61001.042.17 |