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Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin

NCT03149432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-12-03

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.

Conditions

  • Amputation
  • Phantom Pain Following Amputation of Lower Limb

Interventions

PROCEDURE

Mirror Therapy

by a mirror effect the patient sees his remaining arm at the place of the amputated arm that cause an illusion of presence of this arm to the brain and would have an effect of reducing phantom pain

DRUG

Gabapentin

titration of Gabapentin up to 3600 mg or maximum tolerated dose for 8 weeks

PROCEDURE

Rehabilitation

Daily care with physiotherapist ; orthoprosthetists , and specialized sports educators ; if necessary : occupational therapy.

OTHER

Local care

local care for directed healing of the stump.

Sponsors & Collaborators

  • Centre d'Investigation Clinique et Technologique 805

    lead OTHER

Principal Investigators

  • Larlène Lacout, MD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149432 on ClinicalTrials.gov