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Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860403
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Tetraplegia C5-C6 Tetraplegia C6-C7 Procedure: motor imagery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: C6-C7 patients
C6-C7 patients able to recover tenodesis grasp.
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).

Experimental: C5-C6 patients
C5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation
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).

No Intervention: Control group
a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder



Primary Outcome Measures :
  1. Motor imagery ability [ Time Frame: 10 weeks ]
    Motor imagery ability assessed by magnetoencephalography measurements


Secondary Outcome Measures :
  1. Movement time (MT) [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: temporal parameters: movement time (MT)

  2. absolute time to peak velocity [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: temporal parameters: absolute time to peak velocity

  3. movement amplitude at peak velocity [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity

  4. time to opening [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: temporal parameters: time to opening

  5. time to maximal opening [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: temporal parameters: time to maximal opening

  6. amplitude of maximal opening [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: temporal parameters: amplitude of maximal opening

  7. Trajectory of movement measured in the XY plane [ Time Frame: 10 weeks ]
    Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane

  8. height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane [ Time Frame: 10 weeks ]
    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

  9. muscular force evaluated by muscle testing performed by a physiotherapist [ Time Frame: 10 weeks ]
    muscular force evaluated by muscle testing performed by a physiotherapist (score from 0 to 5)

  10. joint amplitude evaluated in degrees (°) by the physiotherapist [ Time Frame: 10 weeks ]
  11. Box and Block test [ Time Frame: 10 weeks ]
    Box and Block test performed by an occupational therapist

  12. Minnesota test. [ Time Frame: 10 weeks ]
    Minnesota test performed by an occupational therapist

  13. amplitude of electrodermal responses [ Time Frame: 10 weeks ]
    mental chronometric assessment associated with acquisition of electrodermal responses

  14. duration of electrodermal responses [ Time Frame: 10 weeks ]
    mental chronometric assessment associated with acquisition of electrodermal responses

  15. Kinesthetic and Visual Imagery Questionnaire [ Time Frame: 10 weeks ]
    The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860403


Locations
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France
Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,
Saint-Genis-Laval, France, 69230
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gilles RODE, Pr Hospices Civils de Lyon
Publications of Results:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02860403    
Other Study ID Numbers: 2008-541
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
Cervical spinal cord injury
Motor imagery
Magnetoencephalography
Additional relevant MeSH terms:
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Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases