Motor Imagery Practice on Amputees (MIPA)

NCT ID: NCT03125538

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-25

Study Completion Date

2017-10-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Rehabilitation

Keywords

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Motor Imagery Amputation Functional rehabilitation Locomotion Phantom-limb pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Motor Imagery

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

Group Type EXPERIMENTAL

Motor Imagery

Intervention Type OTHER

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.

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).

Group Type ACTIVE_COMPARATOR

Control Task

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire Interuniversitaire de Biologie de la Motricité

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aymeric Guillot, Professor

Role: PRINCIPAL_INVESTIGATOR

Laboratoire Interuniversitaire de Biologie de la Motricité

Locations

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Centre Médico-Chirirgical de Réadaptation des Massues

Lyon, Rhône, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle Laroyenne, Doctor

Role: CONTACT

Phone: +33 472 38 46 18

Email: [email protected]

Elodie Saruco, Master

Role: CONTACT

Phone: +33 626 38 49 50

Email: [email protected]

Facility Contacts

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Isabelle Laroyenne, Doctor

Role: primary

Elodie Saruco, Master

Role: backup

References

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Saruco E, Saimpont A, Di Rienzo F, De Witte B, Laroyenne I, Mateo F, Lapenderie M, Solard SG, Perretant I, Frenot C, Jackson PL, Guillot A. Towards efficient motor imagery interventions after lower-limb amputation. J Neuroeng Rehabil. 2024 Apr 15;21(1):55. doi: 10.1186/s12984-024-01348-3.

Reference Type DERIVED
PMID: 38622634 (View on PubMed)

Other Identifiers

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Libm

Identifier Type: -

Identifier Source: org_study_id