Motor Imagery Practice on Amputees (MIPA) (MIPA)

April 27, 2017 updated by: Laboratoire Interuniversitaire de Biologie de la Motricité

Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation

Motor imagery practice (MIP), which is the repeated internal representation of a movement without engaging its physical execution and which shares a neurofunctional equivalence with physical practice, has been show to contribute to promote motor recovery and pain alleviation. Despite the extensive body of evidence concerning MIP therapeutic effects, the impact of mental training during lower-limb amputees' rehabilitation process remains to be investigated. This study was designed to assess MIP effects on the relearning of walking and the frequency and intensity of phantom-limb pain among acute lower-limb amputees. Data should contribute to scale up the tools made available to therapists and extend the scope of MIP application. Moreover, results may contribute to directly provide patients recovering from a lower-limb amputation with a cost-effective and adaptable technique that could considerably improve their quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Arms:

Arm label: Experimental

Arm type: Experimental

Arm description: Participants from the experimental group will perform MIP concomitantly with usual physical rehabilitation program.

Intervention type: Other

Intervention name: Motor Imagery Practice of locomotor tasks

Intervention Description: Together with physical rehabilitation performed with physiotherapists, participants from the experimental group will mentally rehearse 3 different locomotor exercises that they already physically performed beforehand.

Exercise 1: 10m Walk

Exercise 2: Timed Up and Go test (rise up from a chair, walk 3 meters, turn around, come back to the chair, turn around and sit down)

Exercise 3: Stairs climbing test (climb up 4 stairs, turn around, climb down the for stairs)

Two min of MIP will be scheduled 5 times/day, during rest periods, so that patients complete 10min of MIP per day.

Locomotor capacities and phantom-limb pain intensity will be assessed at 5 different moments of the functional rehabilitation:

Evaluation 1: first day of functional rehabilitation Evaluation 2: right after prosthesis fitting and when patients are able to walk with it during 10min Evaluation 3: three weeks after the second evaluation (to have temporally equivalent data for all patients) Evaluation 4: one week before leaving the rehabilitation center (to have functionally equivalent data for all patients) Evaluation 5: six weeks after patients left the center, for follow-up assessment

Arm label: Control

Arm type: Active comparator

Arm description: Concomitantly with usual physical rehabilitation program, participants from the control group will perform a cognitive task that has no impact on motor rehabilitation (word scramble game).

Intervention type: Other

Intervention name: Control cognitive task

Intervention Description: Together with physical rehabilitation performed with physiotherapists, participants from the control group will spend equivalent time focusing on a cognitive task without impact on motor rehabilitation.

Two min of this cognitive task will be scheduled 5 times/day, during rest periods, so that patients complete 10min of control task per day.

As for patients of the experimental group, locomotor capacities and phantom-limb pain intensity of participants from the control group will be assessed at 5 different moments of the functional rehabilitation:

Evaluation 1: first day of functional rehabilitation Evaluation 2: right after prosthesis fitting and when patients are able to walk with it during 10min Evaluation 3: three weeks after the second evaluation (to have temporally equivalent data for all patients) Evaluation 4: one week before leaving the rehabilitation center (to have functionally equivalent data for all patients) Evaluation 5: six weeks after patients left the center, for follow-up assessment

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Rhône
      • Lyon, Rhône, France, 69322
        • Recruiting
        • Centre Médico-Chirirgical de Réadaptation des Massues
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aymeric Guillot, Professor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suffering from acute transtibial or transfemoral lower-limb amputation
  • Having signed informed consent for an clinical study
  • Having a score above 24/30 at the Mini Mental Status Examination

Exclusion Criteria:

  • Persons under any administrative/judicial measure
  • Participants refusing to be informed of the results of the experiment
  • Persons with other motor impairments
  • Persons with neurologic and/or psychiatric disorders

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motor Imagery
Participants from the experimental group will perform MIP concomitantly with usual physical rehabilitation program.
Other: Motor Imagery

Together with physical rehabilitation performed with physiotherapists, participants from the experimental group will mentally rehearse 3 different locomotor exercises that they already physically performed beforehand.

Exercise 1: 10m Walk

Exercise 2: Timed Up and Go test (rise up from a chair, walk 3 meters, turn around, come back to the chair, turn around and sit down)

Exercise 3: Stairs climbing test (climb up 4 stairs, turn around, climb down the for stairs)

Two min of MIP will be scheduled 5 times/day, during rest periods, so that patients complete 10min of MIP per day.
Active Comparator: Control task
Concomitantly with usual physical rehabilitation program, participants from the control group will perform a cognitive task that has no impact on motor rehabilitation (word scramble game).
Other: Control Task

Together with physical rehabilitation performed with physiotherapists, participants from the control group will spend equivalent time focusing on a cognitive task without impact on motor rehabilitation ((word scramble game).

Two min of this cognitive task will be scheduled 5 times/day, during rest periods, so that patients complete 10min of control task per day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MIP effects on simple walking
Time Frame: From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
Duration required to perform a 10m walk will be assessed at 1) patients first day of functional rehabilitation, 2) right after prosthesis fitting and when they are able to walk with it during 10min, 3) three weeks after the second evaluation (to have temporally equivalent data for all the patients), 4) one week before leaving the rehabilitation center (to have functionally equivalent data for all patients), and 5) six weeks after patients left the center, for follow-up assessment.
From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
MIP effects on the Timed Up and Go test (complex walking task involving turning, and raise and sit movements)
Time Frame: From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
Duration required to perform the test Timed Up and Go will be assessed at 1) patients first day of functional rehabilitation, 2) right after prosthesis fitting and when they are able to walk with it during 10min, 3) three weeks after the second evaluation (to have temporally equivalent data for all the patients), 4) one week before leaving the rehabilitation center (to have functionally equivalent data for all patients), and 5) six weeks after patients left the center, for follow-up assessment.
From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
MIP effects on a climbing locomotor task
Time Frame: From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
Duration required to perform 4 stairs climbing test (up and down) will be assessed at 1) patients first day of functional rehabilitation, 2) right after prosthesis fitting and when they are able to walk with it during 10min, 3) three weeks after the second evaluation (to have temporally equivalent data for all the patients), 4) one week before leaving the rehabilitation center (to have functionally equivalent data for all patients), and 5) six weeks after patients left the center, for follow-up assessment.
From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phantom-limb pain
Time Frame: From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
Patients will rate from 0 (no pain at all) to 100 (the worst pain possible), the intensity of the phantom-limb pain they experienced during the last 24h. Assessment will be performed during the 5 evaluations, as described for the primary outcome measure.
From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
Motor imagery time
Time Frame: From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
The time required to imagine the three locomotor tasks (walking, Timed Up and Go and stairs climbing tests) and a simple movement (hip abduction) will be recorded. Assessment will be performed during the 5 evaluations, as described for the primary outcome measure.
From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
Motor imagery vividness
Time Frame: From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)
The capacity of patients to perform vivid MI (clear images and intense kinesthetic sensations while imaging) will be measured with the Kinesthetic and Visual Motor Imagery Questionnaire. Assessment will be performed during the 5 evaluations, as described for the primary outcome measure.
From first day of functional rehabilitation until patients leave the center (approximately from 6 to 10 weeks depending on their ability to recover enough functional autonomy)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratoire Interuniversitaire de Biologie de la Motricité

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aymeric Guillot, Professor, Laboratoire Interuniversitaire de Biologie de la Motricité

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Libm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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