Motor Imagery Practice on Amputees (MIPA)

Study Overview
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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

Official Title
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Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation

Conditions
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Rehabilitation

Intervention / Treatment
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* Other: Motor Imagery
* Other: Control Task


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Imagery<br>Participants from the experimental group will perform MIP concomitantly with usual physical rehabilitation program. | Other: Motor Imagery<br>* 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.<br>|
| Active Comparator: Control task<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Functional rehabilitation, Locomotion, Phantom-limb pain, Motor Imagery