Tetraplegia C5-C6NCT02860403
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
A study testing motor imagery in people with Tetraplegia C5-C6 and Tetraplegia C6-C7, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetraplegia C5-C6, Tetraplegia C6-C7
- What is being tested?
- motor imagery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,
Saint-Genis-Laval, 69230
About this study
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.
- Conditions
- Tetraplegia C5-C6, Tetraplegia C6-C7
- Being tested
- motor imagery
- Keywords
- Cervical spinal cord injury, Motor imagery, Magnetoencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor imageryProcedure or surgery
Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).
| Study group | Role | What they receive |
|---|---|---|
| C6-C7 patients | Experimental | C6-C7 patients able to recover tenodesis grasp. Receives: Procedure: motor imagery |
| C5-C6 patients | Experimental | C5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation Receives: Procedure: motor imagery |
| Control group | No intervention | a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor imagery ability
Motor imagery ability assessed by magnetoencephalography measurements
Measured: 10 weeks
Secondary outcomes (15)
Movement time (MT)
Kinematic parameters of movement: temporal parameters: movement time (MT)
Measured: 10 weeks
absolute time to peak velocity
Kinematic parameters of movement: temporal parameters: absolute time to peak velocity
Measured: 10 weeks
movement amplitude at peak velocity
Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity
Measured: 10 weeks
time to opening
Kinematic parameters of movement: temporal parameters: time to opening
Measured: 10 weeks
time to maximal opening
Kinematic parameters of movement: temporal parameters: time to maximal opening
Measured: 10 weeks
amplitude of maximal opening
Kinematic parameters of movement: temporal parameters: amplitude of maximal opening
Measured: 10 weeks
Trajectory of movement measured in the XY plane
Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane
Measured: 10 weeks
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
Measured: 10 weeks
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)
Measured: 10 weeks
joint amplitude evaluated in degrees (°) by the physiotherapist
Measured: 10 weeks
Box and Block test
Box and Block test performed by an occupational therapist
Measured: 10 weeks
Minnesota test.
Minnesota test performed by an occupational therapist
Measured: 10 weeks
amplitude of electrodermal responses
mental chronometric assessment associated with acquisition of electrodermal responses
Measured: 10 weeks
duration of electrodermal responses
mental chronometric assessment associated with acquisition of electrodermal responses
Measured: 10 weeks
Kinesthetic and Visual Imagery Questionnaire
The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tetraplegia C5-C6Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles RODE, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860403
- Sponsor's protocol ID
- 2008-541
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29944923
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
- ClinicalTrials.gov ID
- NCT02860403
- Acronym / sponsor ID
- 2008-541
- Conditions
- Tetraplegia C5-C6, Tetraplegia C6-C7
- Keywords
- Cervical spinal cord injury, Motor imagery, Magnetoencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C6-C7 patients | Experimental | Procedure: motor imageryC6-C7 patients able to recover tenodesis grasp. |
| C5-C6 patients | Experimental | Procedure: motor imageryC5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation |
| Control group | No intervention | –a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor imageryIntervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice). | Procedure or surgery | C5-C6 patients, C6-C7 patients |
Primary outcome
Motor imagery ability
Time frame: 10 weeks
Motor imagery ability assessed by magnetoencephalography measurements
15 secondary outcomes
Movement time (MT)
Time frame: 10 weeks
absolute time to peak velocity
Time frame: 10 weeks
movement amplitude at peak velocity
Time frame: 10 weeks
time to opening
Time frame: 10 weeks
time to maximal opening
Time frame: 10 weeks
amplitude of maximal opening
Time frame: 10 weeks
Trajectory of movement measured in the XY plane
Time frame: 10 weeks
height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane
Time frame: 10 weeks
muscular force evaluated by muscle testing performed by a physiotherapist
Time frame: 10 weeks
joint amplitude evaluated in degrees (°) by the physiotherapist
Time frame: 10 weeks
Box and Block test
Time frame: 10 weeks
Minnesota test.
Time frame: 10 weeks
amplitude of electrodermal responses
Time frame: 10 weeks
duration of electrodermal responses
Time frame: 10 weeks
Kinesthetic and Visual Imagery Questionnaire
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 29944923Mateo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles RODE, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor imagery in people with Tetraplegia C5-C6 and Tetraplegia C6-C7, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor imagery ability (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.