Viewing Study NCT03125538



Ignite Creation Date: 2024-05-06 @ 9:59 AM
Last Modification Date: 2024-10-26 @ 12:22 PM
Study NCT ID: NCT03125538
Status: UNKNOWN
Last Update Posted: 2017-04-28
First Post: 2017-04-19

Brief Title: Motor Imagery Practice on Amputees MIPA
Sponsor: Laboratoire Interuniversitaire de Biologie de la Motricité
Organization: Laboratoire Interuniversitaire de Biologie de la Motricité

Study Overview

Official Title: Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation
Status: UNKNOWN
Status Verified Date: 2017-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MIPA
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
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 timesday 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 timesday 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None