Phantom Motor Execution via Myoelectric Pattern Recognition, Augmented Reality, and Serious Gaming as a treatment of Phantom Limb Pai

Completed

• Conditions: Fantoompijn na een amputatie; Phantom Limb Pain

• Registration Number: NL-OMON48734
• Lead Sponsor: Chalmers Technical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: Changes in PLP will be measured in terms of differences between the<br /><br>Pain Rating Index registered at the beginning (1st session) and at the end of<br /><br>the treatment (15th session).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: The effects of the treatment will be measured as changes in the PDI<br /><br>measures at the beginning (1st session) and at the end of the treatment (15th<br /><br>session).</p><br>