Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia (TETRAMINF)
Primary Purpose
Individuals With C6-C7 Tetraplegia (AIS A or B)
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motor imagery combined with neurofeedback (MINF)
Motor imagery (MI)
Control (C)
Sponsored by
About this trial
This is an interventional treatment trial for Individuals With C6-C7 Tetraplegia (AIS A or B) focused on measuring Tenodesis grasp, Neurofeedback, Motor imagery, Reach-to-grasp, Rehabilitation, Physical therapy, Cervical spinal cord injury, Tetraplegia, AIS A, AIS B
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).
Sites / Locations
- Le Centre Mutualiste Neurologique PROPARA, Parc EuromédecineRecruiting
- Service de médecine physique et de réadaptation, Hôpital Henry GabrielleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Motor imagery combined with neurofeedback (MINF)
Motor imagery (MI)
Control (C)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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.
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.
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
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
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
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
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.
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.
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.
Full Information
NCT ID
NCT03190863
First Posted
April 25, 2017
Last Updated
September 28, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03190863
Brief Title
Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia
Acronym
TETRAMINF
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
May 29, 2025 (Anticipated)
Study Completion Date
May 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motor imagery combined with neurofeedback (MINF)
Arm Type
Experimental
Arm Title
Motor imagery (MI)
Arm Type
Active Comparator
Arm Title
Control (C)
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motor imagery combined with neurofeedback (MINF)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor imagery (MI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control (C)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wrist extension angle in degree during grasping with 3D motion analysis system
Description
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.
Time Frame
Up to 19 weeks
Secondary Outcome Measure Information:
Title
Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
Description
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.
Time Frame
Up to 19 weeks
Title
Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
Description
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.
Time Frame
Up to 19 weeks
Title
Brain activity change in response to intervention using magnetoencephalography
Description
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.
Time Frame
Up to 19 weeks
Title
passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer
Description
This outcome will be measured using goniometer and/or inclinometer by the same blind and experienced physical therapist
Time Frame
Up to 19 weeks
Title
Upper limb strength measured using the hand held dynamometer
Description
This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist.
Time Frame
Up to 19 weeks
Title
Upper limb strength measured using the manual muscle test
Description
This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist.
Time Frame
Up to 19 weeks
Title
Hand dexterity measured using the Box and Block test
Description
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
Time Frame
Up to 19 weeks
Title
Hand dexterity measured using the Nine Hole Peg test
Description
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
Time Frame
Up to 19 weeks
Title
Hand dexterity measured using the Jebsen test
Description
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
Time Frame
Up to 19 weeks
Title
Hand dexterity measured using the Capability of Upper Limb test
Description
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
Time Frame
Up to 19 weeks
Title
Quality of Life measured using the WHOQOL-Bref
Description
This outcome will be measured using the WHOQOL-Bref by the same blind and experienced physical therapist.
Time Frame
Up to 19 weeks
Title
Daily life autonomy measured using the Quadriplegic Index of Function
Description
This outcome will be measured using the Quadriplegic Index of Function by the same blind and experienced physical therapist.
Time Frame
Up to 19 weeks
Title
Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire
Description
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.
Time Frame
Up to 19 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien MATEO, PhD
Phone
478 865 066
Ext
+33
Email
sebastien.mateo@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles RODE, PhD
Phone
478 865 066
Ext
+33
Email
gilles.rode@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien MATEO, PhD
Organizational Affiliation
Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony GELIS, MD
Email
a.gelis@propara.fr
First Name & Middle Initial & Last Name & Degree
Anthony GELIS, MD
Facility Name
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien MATEO
Email
ext-sebastien.mateo@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Gilles RODE, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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:
Box and Block test
Nine Hole Peg test
hand held dynamometer for each of 4 muscles
This includes for each visit and each participant the total score of:
manual muscle testing of the upper limb key muscles as defined by the ASIA score for each arm
Capability of Upper Limb
WHOQOL-Bref
Quadriplegic Index of Function
Kinesthetic Visual Imagery Questionnaire This also includes for each visit and each participant the passive range of motion expressed in degree and measured using goniometer for shoulder, elbow and wrist.
This do not include electrophysiological measurements.
IPD Sharing Time Frame
Immediately following publication and ending 5 years following article publication.
IPD Sharing Access Criteria
Proposals should be directed to sebastien.mateo@chu-lyon.fr. To gain access, data requestors will need to sign a data access agreement.
Citations:
PubMed Identifier
26409412
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.
Results Reference
background
Links:
URL
https://www.cermep.fr/ged.php?login=vvv&catagenda=678404593d4722c&pk_orga=9&pkcateg=238
Description
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Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia
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