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Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

Primary Purpose

Tetraplegia C5-C6, Tetraplegia C6-C7

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
motor imagery
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tetraplegia C5-C6 focused on measuring Cervical spinal cord injury, Motor imagery, Magnetoencephalography

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

C6-C7 patients

C5-C6 patients

Control group

Arm Description

C6-C7 patients able to recover tenodesis grasp.

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

a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder

Outcomes

Primary Outcome Measures

Motor imagery ability
Motor imagery ability assessed by magnetoencephalography measurements

Secondary Outcome Measures

Movement time (MT)
Kinematic parameters of movement: temporal parameters: movement time (MT)
absolute time to peak velocity
Kinematic parameters of movement: temporal parameters: absolute time to peak velocity
movement amplitude at peak velocity
Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity
time to opening
Kinematic parameters of movement: temporal parameters: time to opening
time to maximal opening
Kinematic parameters of movement: temporal parameters: time to maximal opening
amplitude of maximal opening
Kinematic parameters of movement: temporal parameters: amplitude of maximal opening
Trajectory of movement measured in the XY plane
Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane
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
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)
joint amplitude evaluated in degrees (°) by the physiotherapist
Box and Block test
Box and Block test performed by an occupational therapist
Minnesota test.
Minnesota test performed by an occupational therapist
amplitude of electrodermal responses
mental chronometric assessment associated with acquisition of electrodermal responses
duration of electrodermal responses
mental chronometric assessment associated with acquisition of electrodermal responses
Kinesthetic and Visual Imagery Questionnaire
The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients

Full Information

First Posted
August 4, 2016
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02860403
Brief Title
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
Official Title
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia C5-C6, Tetraplegia C6-C7
Keywords
Cervical spinal cord injury, Motor imagery, Magnetoencephalography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C6-C7 patients
Arm Type
Experimental
Arm Description
C6-C7 patients able to recover tenodesis grasp.
Arm Title
C5-C6 patients
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder
Intervention Type
Procedure
Intervention Name(s)
motor imagery
Intervention Description
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).
Primary Outcome Measure Information:
Title
Motor imagery ability
Description
Motor imagery ability assessed by magnetoencephalography measurements
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Movement time (MT)
Description
Kinematic parameters of movement: temporal parameters: movement time (MT)
Time Frame
10 weeks
Title
absolute time to peak velocity
Description
Kinematic parameters of movement: temporal parameters: absolute time to peak velocity
Time Frame
10 weeks
Title
movement amplitude at peak velocity
Description
Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity
Time Frame
10 weeks
Title
time to opening
Description
Kinematic parameters of movement: temporal parameters: time to opening
Time Frame
10 weeks
Title
time to maximal opening
Description
Kinematic parameters of movement: temporal parameters: time to maximal opening
Time Frame
10 weeks
Title
amplitude of maximal opening
Description
Kinematic parameters of movement: temporal parameters: amplitude of maximal opening
Time Frame
10 weeks
Title
Trajectory of movement measured in the XY plane
Description
Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane
Time Frame
10 weeks
Title
height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane
Description
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
Time Frame
10 weeks
Title
muscular force evaluated by muscle testing performed by a physiotherapist
Description
muscular force evaluated by muscle testing performed by a physiotherapist (score from 0 to 5)
Time Frame
10 weeks
Title
joint amplitude evaluated in degrees (°) by the physiotherapist
Time Frame
10 weeks
Title
Box and Block test
Description
Box and Block test performed by an occupational therapist
Time Frame
10 weeks
Title
Minnesota test.
Description
Minnesota test performed by an occupational therapist
Time Frame
10 weeks
Title
amplitude of electrodermal responses
Description
mental chronometric assessment associated with acquisition of electrodermal responses
Time Frame
10 weeks
Title
duration of electrodermal responses
Description
mental chronometric assessment associated with acquisition of electrodermal responses
Time Frame
10 weeks
Title
Kinesthetic and Visual Imagery Questionnaire
Description
The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles RODE, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29944923
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.
Results Reference
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Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

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