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Motor Imagery Practice on Amputees (MIPA) (MIPA)

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ClinicalTrials.gov Identifier: NCT03125538
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoire Interuniversitaire de Biologie de la Motricité

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rehabilitation Other: Motor Imagery Other: Control Task Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: To avoid group contamination, a first group of 10 control participants will be completed. Then, an experimental group of 10 patients will be assessed. In order to complete a 40 persons cohort, this will be repeated one time (other 10 control then 10 experimental participants).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants sign an informed written consent but are not aware of the expectations of the study. Assessments will be performed by a PhD student who does not know neither to which group each participants belongs, nor the expectations of the study.
Primary Purpose: Health Services Research
Official Title: Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation
Actual Study Start Date : February 25, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125538


Contacts
Contact: Isabelle Laroyenne, Doctor +33 472 38 46 18 i-laroyenne@cmcr-massues.com
Contact: Elodie Saruco, Master +33 626 38 49 50 elodie.saruco@univ-lyon1.fr

Locations
France
Centre Médico-Chirirgical de Réadaptation des Massues Recruiting
Lyon, Rhône, France, 69322
Contact: Isabelle Laroyenne, Doctor    +33 472 38 46 18    i-laroyenne@cmcr-massues.com   
Contact: Elodie Saruco, Master    +33 626 38 49 50    elodie.saruco@univ-lyon1.fr   
Principal Investigator: Aymeric Guillot, Professor         
Sponsors and Collaborators
Laboratoire Interuniversitaire de Biologie de la Motricité
Investigators
Principal Investigator: Aymeric Guillot, Professor Laboratoire Interuniversitaire de Biologie de la Motricité

Responsible Party: Laboratoire Interuniversitaire de Biologie de la Motricité
ClinicalTrials.gov Identifier: NCT03125538     History of Changes
Other Study ID Numbers: Libm
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laboratoire Interuniversitaire de Biologie de la Motricité:
Motor Imagery
Amputation
Functional rehabilitation
Locomotion
Phantom-limb pain