Effectivity of Motor Imagery and MirrorTherapy in Amputees

October 11, 2019 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees

This study evaluates the effectiveness of imagery motor on phantom pain and amputation process

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The expected increase in the number of amputations in the coming decades requires special attention to the common effect after called phantom limb amputation. That term refers to the phenomena covering the sensations that occur in the affected limb and whose prevalence rate is an important part of amputees subjects. Developed theories about their origin focus their attention on the central nervous system and the peripheral nervous system. Thus, the imaginary movement is a complex cognitive, sensory and proprioceptive process leading to a mental representation of movement and it is a widely used technique in neurological rehabilitation and complex pain syndrome.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cádiz, Spain, 11510
        • Hospital de Puerto Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pain in the stump area ≥ 3 months, no intermittent
  2. Have three months elapsed amputation,
  3. Submit subjective sensation of phantom limb not blinking

Exclusion Criteria:

  • Clinical signs of radiculopathy.
  • Lumbar stenosis, fibromyalgia, spondylolisthesis.
  • History of spinal surgery.
  • Corticosteroid therapy in the past two weeks.
  • Disease of the central nervous system or peripheral.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Traditional and Motor Imaginary Program
Amputees patients also conservative protocol will undergo physiotherapy techniques work Motor Imaginary Program, based on a system of two videos that allow the patient to recreate the "normal" way. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases. This protocol will be applied 3 days a week (25-30minutos) for one month.
Other: Treatment Traditional and Imaginary Motor Program
Amputees patients also conservative protocol will undergo physiotherapy techniques work Imaginary Motor. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases: a) relaxation of Benson, b) phase external imagination where cycles of normal running on a video provided by the physiotherapist, c) phase internal imagination where the patient will identify the problem discussed compared with the normal course presented in the video, d) recreation of images in the first person made an e normalized locomotion) closing his eyes, prompted the patient to mentally recreate sequences normal gait and analyzed and subsequently verbalize differences of these with respect to their own way of getting around.
Active Comparator: Treatment Traditional and Mirror Therapy
Amputees patients also conservative protocol will undergo physical therapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation.
Other: Treatment Traditional and Mirror Therapy
Amputees patients also conservative protocol will undergo physiotherapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numerical Rating Scale (NRS)
Time Frame: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months
Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGiII Pain Questionnaire (MPQ)
Time Frame: Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months
Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months
The Vividness of Visual Imagery Questionnaire
Time Frame: Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months
Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months
Beck Depression Inventory
Time Frame: Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months
Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months
Neuropathic Pain Questionnaire (DN4)
Time Frame: Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months
Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months
Pressure Algometer (kg/cm2)
Time Frame: Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months
Pressure algometer in lumbar pain, amputated limb and health limb
Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months
West-Haven-Yale Multidimensional Pain Inventory
Time Frame: Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months
Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months
The Barthel Index of ADLs
Time Frame: Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months
Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months
Instrumental Activities of Daily Living Scale (IADL)
Time Frame: Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months
Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months
The Functional Independence Measure Scale (FIM)
Time Frame: Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months
Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months
Quality of Life Questionnaire scoring (SF36)
Time Frame: Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months
Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months
Multidimensional Body Self Relations Questionnaire (MBSRQ)
Time Frame: Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months
Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months
Tampa Scale for Kinesiophobia (TSK)
Time Frame: Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months
Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months
Pain Catastrophizing Scale (PCS)
Time Frame: Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months
Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months
Pain Management Inventory
Time Frame: Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months
Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

May 1, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEI15_25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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