Clinical trial NCT03190863: Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Individuals With C6-C7 Tetraplegia (AIS A or B)
Keywords: Tenodesis grasp
Neurofeedback
Motor imagery
Reach-to-grasp
Rehabilitation
Physical therapy
Cervical spinal cord injury
Tetraplegia
AIS A
AIS B
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Wrist extension angle in degree during grasping with 3D motion analysis system
timeFrame: Up to 19 weeks
Secondary outcomes:
measure: Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
timeFrame: Up to 19 weeks
measure: Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
timeFrame: Up to 19 weeks
measure: Brain activity change in response to intervention using magnetoencephalography
timeFrame: Up to 19 weeks
measure: passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer
timeFrame: Up to 19 weeks
measure: Upper limb strength measured using the hand held dynamometer
timeFrame: Up to 19 weeks
measure: Upper limb strength measured using the manual muscle test
timeFrame: Up to 19 weeks
measure: Hand dexterity measured using the Box and Block test
timeFrame: Up to 19 weeks
measure: Hand dexterity measured using the Nine Hole Peg test
timeFrame: Up to 19 weeks
measure: Hand dexterity measured using the Jebsen test
timeFrame: Up to 19 weeks
measure: Hand dexterity measured using the Capability of Upper Limb test
timeFrame: Up to 19 weeks
measure: Quality of Life measured using the WHOQOL-Bref
timeFrame: Up to 19 weeks
measure: Daily life autonomy measured using the Quadriplegic Index of Function
timeFrame: Up to 19 weeks
measure: Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire
timeFrame: Up to 19 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine
city: Saint-Genis-Laval
country: France
facility: Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle
Study officials:
affiliation: Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
name: Sébastien MATEO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.