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Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback.
The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motor imagery combined with neurofeedback (MINF) | Experimental |
| |
| Motor imagery (MI) | Active Comparator |
| |
| Control (C) | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor imagery combined with neurofeedback (MINF) | Behavioral | 7 individuals with C6-C7 tetraplegia randomize in the experimental group consisting in motor imagery practice combined with visual neurofeedback (NF - i.e. performance of the imagined movement). Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. After each imagined movement, the NF based on brain activity measured by electroencephalography is display on a screen. |
| Measure | Description | Time Frame |
|---|---|---|
| Wrist extension angle in degree during grasping with 3D motion analysis system | Individuals with C6-C7 tetraplegia extend their wrist to grasp using tenodesis. Specifically, the wrist extension shortens the tendons of fingers and thumbs flexors that elicit either a palmar or a lateral grip. A complete reach-to-grasp movement will be recorded using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Wrist extension angle in degree will be measure during grasping when the object is grasped. | Up to 19 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK). | Computation of temporal kinematic parameters (e.g. movement duration) measured during a complete reach-to-grasp movement using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Temporal parameters are also aggregated with spatial parameters. | Up to 19 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sébastien MATEO, PhD | Contact | 478 865 066 | +33 | sebastien.mateo@chu-lyon.fr |
| Gilles RODE, PhD | Contact | 478 865 066 | +33 | gilles.rode@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sébastien MATEO, PhD | Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine | Recruiting | Montpellier | 34090 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409412 | Background | Mateo S, Di Rienzo F, Reilly KT, Revol P, Delpuech C, Daligault S, Guillot A, Jacquin-Courtois S, Luaute J, Rossetti Y, Collet C, Rode G. Improvement of grasping after motor imagery in C6-C7 tetraplegia: A kinematic and MEG pilot study. Restor Neurol Neurosci. 2015;33(4):543-55. doi: 10.3233/RNN-140466. | |
| 39433413 | Derived |
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Individual participant data will be shared after deidentification (but only the data required for the new analysis will be transmitted). This includes for each visit and each participant averaged data of wrist extension angle during grasping of a single upper limb measured in degree with 3D motion analysis system.
This includes for each visit, each participant and each upper limb:
This includes for each visit and each participant the total score of:
This do not include electrophysiological measurements.
Immediately following publication and ending 5 years following article publication.
Proposals should be directed to sebastien.mateo@chu-lyon.fr. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Motor imagery (MI) | Behavioral | 7 individuals with C6-C7 tetraplegia randomized in the active comparator group consisting in motor imagery practice alone without visual NF. This means that the performance of the imagined movement is not displayed to the participants. Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. |
|
| Control (C) | Behavioral | 7 individuals with C6-C7 tetraplegia randomized in the sham comparator group consisting in imagining geometric shapes by visualization. Shapes are successively displayed on a screen. Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. |
|
| Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK). | Computation of spatial kinematic parameters (e.g. movement trajectory) measured during a complete reach-to-grasp movement using a 3D motion analysis system (Vicon Motion Systems Ltd. UK).Spatial parameters are also aggregated with temporal parameters. | Up to 19 weeks |
| Brain activity change in response to intervention using magnetoencephalography | Brain activity will be measured during upper limb movement (e.g. a complete reach-to-grasp movement) using magnetoencephalography. The device is only available in Lyon Hospital. Correspondingly, fifteen participants included in Lyon Hospital will achieve this measure. | Up to 19 weeks |
| passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer | This outcome will be measured using goniometer and/or inclinometer by the same blind and experienced physical therapist | Up to 19 weeks |
| Upper limb strength measured using the hand held dynamometer | This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist. | Up to 19 weeks |
| Upper limb strength measured using the manual muscle test | This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist. | Up to 19 weeks |
| Hand dexterity measured using the Box and Block test | This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist | Up to 19 weeks |
| Hand dexterity measured using the Nine Hole Peg test | This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist | Up to 19 weeks |
| Hand dexterity measured using the Jebsen test | This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist | Up to 19 weeks |
| Hand dexterity measured using the Capability of Upper Limb test | This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist | Up to 19 weeks |
| Quality of Life measured using the WHOQOL-Bref | This outcome will be measured using the WHOQOL-Bref by the same blind and experienced physical therapist. | Up to 19 weeks |
| Daily life autonomy measured using the Quadriplegic Index of Function | This outcome will be measured using the Quadriplegic Index of Function by the same blind and experienced physical therapist. | Up to 19 weeks |
| Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire | Motor imagery capability will be measured by the Kinesthetic Visual Imagery Questionnaire by the same blind and experienced physical therapist along with comparing overt and covert movement duration, galvanic skin response, electroencephalography activity. | Up to 19 weeks |
| Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle | Recruiting | Saint-Genis-Laval | 69230 | France |
|
| Charbonnier G, Reilly KT, Schwartz D, Daligault S, Luaute J, Rossetti Y, Collet C, Gelis A, Rode G, Mateo S. Grasping rehabilitation using motor imagery with or without neurofeedback after tetraplegia: a study protocol for a bicentric randomised controlled trial. BMJ Open. 2024 Oct 21;14(10):e074652. doi: 10.1136/bmjopen-2023-074652. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |