Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02860403
Other study ID # 2008-541
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2013
Est. completion date March 2013

Study information

Verified date August 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
motor imagery
Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).

Locations

Country Name City State
France Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles, Saint-Genis-Laval

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Motor imagery ability Motor imagery ability assessed by magnetoencephalography measurements 10 weeks
Secondary Movement time (MT) Kinematic parameters of movement: temporal parameters: movement time (MT) 10 weeks
Secondary absolute time to peak velocity Kinematic parameters of movement: temporal parameters: absolute time to peak velocity 10 weeks
Secondary movement amplitude at peak velocity Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity 10 weeks
Secondary time to opening Kinematic parameters of movement: temporal parameters: time to opening 10 weeks
Secondary time to maximal opening Kinematic parameters of movement: temporal parameters: time to maximal opening 10 weeks
Secondary amplitude of maximal opening Kinematic parameters of movement: temporal parameters: amplitude of maximal opening 10 weeks
Secondary Trajectory of movement measured in the XY plane Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane 10 weeks
Secondary height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane Kinematic parameters of movement: spatial parameters: height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane 10 weeks
Secondary muscular force evaluated by muscle testing performed by a physiotherapist muscular force evaluated by muscle testing performed by a physiotherapist (score from 0 to 5) 10 weeks
Secondary joint amplitude evaluated in degrees (°) by the physiotherapist 10 weeks
Secondary Box and Block test Box and Block test performed by an occupational therapist 10 weeks
Secondary Minnesota test. Minnesota test performed by an occupational therapist 10 weeks
Secondary amplitude of electrodermal responses mental chronometric assessment associated with acquisition of electrodermal responses 10 weeks
Secondary duration of electrodermal responses mental chronometric assessment associated with acquisition of electrodermal responses 10 weeks
Secondary Kinesthetic and Visual Imagery Questionnaire The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients 10 weeks