Tetraplegia C5-C6 Clinical Trial
Official title:
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
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 |
Verified date | August 2016 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles, | Saint-Genis-Laval |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
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
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 |