Clinical trial NCT02860403: Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
Official title: Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetraplegia C5-C6
Tetraplegia C6-C7
Keywords: Cervical spinal cord injury
Motor imagery
Magnetoencephalography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.


Eligibility criteria: Inclusion Criteria:

* 18-55 years old,
* quadriplegia elicited by spinal cord injury (SCI) at the C5, C5-C6, C6, or C6-C7 level,
* complete infra-lesional motor deficit according to the ASIA impairment scale with finger and forearm flexor muscles paralysis,
* post-traumatic period \>6 months (since a motor recovery plateau is usually reached at 6-month post-SCI

Exclusion Criteria:

* non-stabilized hypertension or pathological autonomic nervous system dysfunction (e.g., orthostatic hypotension),
* cerebral damage and/or cognitive deficit,
* elbow or shoulder joint amplitude restriction, upper limb para-osteoarthropathy,
* participation to another study
* presence of metallic objects within the body incompatible with MEG or functional magnetic resonance imaging (fMRI) recordings.

Primary outcomes:
measure: Motor imagery ability
timeFrame: 10 weeks
Secondary outcomes:
measure: Movement time (MT)
timeFrame: 10 weeks
measure: absolute time to peak velocity
timeFrame: 10 weeks
measure: movement amplitude at peak velocity
timeFrame: 10 weeks
measure: time to opening
timeFrame: 10 weeks
measure: time to maximal opening
timeFrame: 10 weeks
measure: amplitude of maximal opening
timeFrame: 10 weeks
measure: Trajectory of movement measured in the XY plane
timeFrame: 10 weeks
measure: height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane
timeFrame: 10 weeks
measure: muscular force evaluated by muscle testing performed by a physiotherapist
timeFrame: 10 weeks
measure: joint amplitude evaluated in degrees (°) by the physiotherapist
timeFrame: 10 weeks
measure: Box and Block test
timeFrame: 10 weeks
measure: Minnesota test.
timeFrame: 10 weeks
measure: amplitude of electrodermal responses
timeFrame: 10 weeks
measure: duration of electrodermal responses
timeFrame: 10 weeks
measure: Kinesthetic and Visual Imagery Questionnaire
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,
Study officials:
affiliation: Hospices Civils de Lyon
name: Gilles RODE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mateo S, Reilly KT, Collet C, Rode G. Descriptive pilot study of vividness and temporal equivalence during motor imagery training after quadriplegia. Ann Phys Rehabil Med. 2018 Sep;61(5):300-308. doi: 10.1016/j.rehab.2018.06.003. Epub 2018 Jun 23.