Individuals With C6-C7 Tetraplegia (AIS A or B) Clinical Trial
— TETRAMINFOfficial title:
Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.
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.
| Status | Recruiting |
| Enrollment | 21 |
| Est. completion date | May 29, 2025 |
| Est. primary completion date | May 29, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Volunteer individuals with C6-C7 tetraplegia with complete finger flexor paralysis restricting grasping capabilities to the tenodesis. - Consent to participate to the study after receiving clear, loyal and appropriate information. - Aged between 18 and 55 years. - Time since spinal cord injury above 6 months - Stabilized condition in particular sensori-motor deficit. - Sitting position for more than 1 hour - Able to imagine movement - Health care beneficiary Exclusion Criteria: - Long-lasting autonomic disorders while sitting (orthostatic hypotension and/or blood pressure instability) limiting sitting position to less than 1 hour. - Upper limb pain for either mechanic or neuropathic reasons preventing all grasping movement and/or the ability to imagine those movements. - Restricted wrist and finger range of motion preventing the tenodesis grasp. - Patient after surgical tendon transfer that improved grasping capabilities (e.g. active finger flexion). - Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias. - Specific contraindication to Magnetoencephalography with the presence of metallic fragments inside the body such as pace-maker, neurostimulator, cochlear implants, steel dental implant and osteosynthesis material only applicable to the participants included in Lyon hospital center (n=15). |
| Country | Name | City | State |
|---|---|---|---|
| France | Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine | Montpellier | |
| France | Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle | Saint-Genis-Laval |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |