Motor Imagery Practice on Amputees (MIPA)

NCT03125538 | Unknown

• 1 other identifier: Libm
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

Motor Imagery; Amputation; Functional rehabilitation; Locomotion; Phantom-limb pain

Outcome Measures

Primary Outcomes (3)

• MIP effects on simple walking

  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)

  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

  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 Outcomes (3)

• Phantom-limb pain

  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

  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

  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)

Study Arms (2)

Motor Imagery

EXPERIMENTAL

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

Other: Motor Imagery

Control task

ACTIVE COMPARATOR

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

Interventions

Motor Imagery 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.

Motor Imagery

Control Task 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.

Control task

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoire Interuniversitaire de Biologie de la Motricité: lead

Study Sites (1)

Centre Médico-Chirirgical de Réadaptation des Massues

Lyon, Rhône, 69322, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 38622634 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Aymeric Guillot, Professor

  Laboratoire Interuniversitaire de Biologie de la Motricité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Laroyenne, Doctor

CONTACT

+33 472 38 46 18; i-laroyenne@cmcr-massues.com

Elodie Saruco, Master

CONTACT

+33 626 38 49 50; elodie.saruco@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: February 25, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)