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Clinical Trials/NCT03125538
NCT03125538UnknownNot Applicable

Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation

Laboratoire Interuniversitaire de Biologie de la Motricité2 sites in 1 country40 target enrollmentStarted: February 25, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
MIP effects on simple walking

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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

  • 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

Outcomes

Primary Outcomes

MIP effects on simple walking

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)

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.

MIP effects on the Timed Up and Go test (complex walking task involving turning, and raise and sit movements)

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)

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.

MIP effects on a climbing locomotor task

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)

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.

Secondary Outcomes

  • 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))
  • 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))

Investigators

Sponsor
Laboratoire Interuniversitaire de Biologie de la Motricité
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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