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Status unknownNCT03125538MIPAUpdated Apr 28, 2017

Motor Imagery Practice on Amputees (MIPA)

An interventional study of Motor Imagery and Control Task in Rehabilitation, sponsored by Laboratoire Interuniversitaire de Biologie de la Motricité. Status unknown at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-28.

Sponsored by Laboratoire Interuniversitaire de Biologie de la Motricité · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Rehabilitation

Keywords

  • Motor Imagery
  • Amputation
  • Functional rehabilitation
  • Locomotion
  • Phantom-limb pain
03

In context

Lead sponsor

Laboratoire Interuniversitaire de Biologie de la Motricité is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Motor Imagery

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

    Other: Motor Imagery

  • 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

Interventions

  • OtherMotor 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.

  • OtherControl 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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)

  2. 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.

    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)

  3. 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.

    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)

Secondary outcomes

  1. Phantom-limb pain

    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.

    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)

  2. Motor imagery time

    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.

    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)

  3. Motor imagery vividness

    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.

    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)

07

Study locations

1 of 1 sites recruiting
  • Centre Médico-Chirirgical de Réadaptation des Massues
    Lyon, Rhône 69322, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03125538
Lead sponsor
Laboratoire Interuniversitaire de Biologie de la Motricité
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
Feb 25, 2017
Primary completion
Oct 30, 2017 (estimated)
Completion
Oct 30, 2017 (estimated)
Last update
Apr 28, 2017

Study contacts

Isabelle Laroyenne, Doctor
Contact
i-laroyenne@cmcr-massues.com
+33 472 38 46 18
Elodie Saruco, Master
Contact
elodie.saruco@univ-lyon1.fr
+33 626 38 49 50
Aymeric Guillot, Professor
principal investigator · Laboratoire Interuniversitaire de Biologie de la Motricité

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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