Motor Imagery Practice on Amputees (MIPA)

Rehabilitation Clinical Trial

— MIPA  

Official title:

Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03125538
• Other study ID #: Libm
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2017
• Last updated: April 27, 2017
• Start date: February 25, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: April 2017
• Source: Laboratoire Interuniversitaire de Biologie de la Motricité
• Contact: Isabelle Laroyenne, Doctor
• Phone: +33 472 38 46 18
• Email: i-laroyenne[@]cmcr-massues.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre Médico-Chirirgical de Réadaptation des Massues	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire Interuniversitaire de Biologie de la Motricité

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)