- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860403
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
May 23, 2019 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint-Genis-Laval, France, 69230
- Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: C6-C7 patients
C6-C7 patients able to recover tenodesis grasp.
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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).
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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
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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).
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No Intervention: Control group
a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor imagery ability
Time Frame: 10 weeks
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Motor imagery ability assessed by magnetoencephalography measurements
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10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement time (MT)
Time Frame: 10 weeks
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Kinematic parameters of movement: temporal parameters: movement time (MT)
|
10 weeks
|
absolute time to peak velocity
Time Frame: 10 weeks
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Kinematic parameters of movement: temporal parameters: absolute time to peak velocity
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10 weeks
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movement amplitude at peak velocity
Time Frame: 10 weeks
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Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity
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10 weeks
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time to opening
Time Frame: 10 weeks
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Kinematic parameters of movement: temporal parameters: time to opening
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10 weeks
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time to maximal opening
Time Frame: 10 weeks
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Kinematic parameters of movement: temporal parameters: time to maximal opening
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10 weeks
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amplitude of maximal opening
Time Frame: 10 weeks
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Kinematic parameters of movement: temporal parameters: amplitude of maximal opening
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10 weeks
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Trajectory of movement measured in the XY plane
Time Frame: 10 weeks
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Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane
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10 weeks
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height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane
Time Frame: 10 weeks
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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
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10 weeks
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muscular force evaluated by muscle testing performed by a physiotherapist
Time Frame: 10 weeks
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muscular force evaluated by muscle testing performed by a physiotherapist (score from 0 to 5)
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10 weeks
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joint amplitude evaluated in degrees (°) by the physiotherapist
Time Frame: 10 weeks
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10 weeks
|
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Box and Block test
Time Frame: 10 weeks
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Box and Block test performed by an occupational therapist
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10 weeks
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Minnesota test.
Time Frame: 10 weeks
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Minnesota test performed by an occupational therapist
|
10 weeks
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amplitude of electrodermal responses
Time Frame: 10 weeks
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mental chronometric assessment associated with acquisition of electrodermal responses
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10 weeks
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duration of electrodermal responses
Time Frame: 10 weeks
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mental chronometric assessment associated with acquisition of electrodermal responses
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10 weeks
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Kinesthetic and Visual Imagery Questionnaire
Time Frame: 10 weeks
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The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients
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10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilles RODE, Pr, Hospices Civils de Lyon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 8, 2016
First Posted (Estimate)
August 9, 2016
Study Record Updates
Last Update Posted (Actual)
May 28, 2019
Last Update Submitted That Met QC Criteria
May 23, 2019
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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