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Trial registered on ANZCTR


Registration number
ACTRN12612001030864
Ethics application status
Approved
Date submitted
21/09/2012
Date registered
25/09/2012
Date last updated
25/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Grasp rehabilitation with motor imagery after spinal cord injury
Scientific title
In quadriplegic patients with chronic non-evolutive motor impairments does motor rehabilitation including mental training with motor imagery improve residual upper limb motor functions through the induction of cerebral reorganizations potentially reflected during motor imagery?
Secondary ID [1] 281257 0
Nil
Universal Trial Number (UTN)
U1111-1134-6932
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injuries 287450 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287790 287790 0 0
Physiotherapy
Injuries and Accidents 287820 287820 0 0
Other injuries and accidents
Neurological 287829 287829 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mental practice with motor imagery, whereby participants visualise themselves grasping objects. Different motor imagery modalities are used (e.g. visual, kinesthetic, etc.) focusing various tenodesis grasping skills (e.g. different seizes of objects, contralateral and ipsilateral tenodesis grasping actions.. etc.). Administration mode: one-on-one supervision by a physiotherapist. Frequency and duration of mental practice sessions: SCI patients underwent 3×30 minutes sessions per week for 5 weeks.
Intervention code [1] 285727 0
Rehabilitation
Intervention code [2] 285728 0
Treatment: Other
Comparator / control treatment
Posttest level is compared with the baseline pretests level (i.e. before rehabiltiative interventions with mental training) in spinal cord injured patients. Age and sex-matched healthy control participants follow similar a repeated pretests and posttest assessments procedure. They do not recieve rehabilitative interventions but a control task (i.e. playing cards with a physiotherapist 3×30 minutes per week for 5 weeks).
Control group
Active

Outcomes
Primary outcome [1] 288025 0
Kinematic analysis of tenodesis grasp actions
Timepoint [1] 288025 0
At weeks 1, 3 and 5 following inclusion and at weeks 1 and 8 following intervention. Experimental intervention is administered during weeks 6 to 10 relative to patient's inclusion.
Primary outcome [2] 288026 0
Magnetoencephalographic cerebral activity during imagined and executed tenodesis grasp actions
Timepoint [2] 288026 0
At weeks 1, 3 and 5 following inclusion and at weeks 1 and 8 following intervention. Experimental intervention is administered during weeks 6 to 10 relative to inclusion.
Primary outcome [3] 288040 0
Autonomic nervous system (i.e. heart rate and electrodermal activity) activity during imagined and executed tenodesis grasp actions. We used an autonomic nervous system acquisition device (E-MOTION) and recorded the electrocardiogram. We also recorded skin resistance responses, using two 50 mm2 unpolarizable Ag/AgCl electrodes (Clark Electromedical Instruments, Ref. E243) placed on upper limb regions correponding where sympathetic innervation was spared by the neurological lesion. Isotonic conductive paste was used to improve skin/electrode contact. Skin resistance was recorded with 15 uA current (current density=0.5 uA/mm2).
Timepoint [3] 288040 0
At weeks 1, 3 and 5 following inclusion and at weeks 1 and 8 following intervention
Secondary outcome [1] 299299 0
Motor imagery ability assessment with mental chronometry
Timepoint [1] 299299 0
At weeks 1, 3 and 5 following inclusion and at weeks 1 and 8 after experimental intervention. Experimental intervention is administered during weeks 6 to 10 relative to inclusion.
Secondary outcome [2] 299301 0
Motor imagery ability assessment with the Kinesthetic and Visual Imagery Questionnaire
Timepoint [2] 299301 0
At week 1 following inclusion, before the first kinematic analysis and magnetoencephalographic recording.
Secondary outcome [3] 299303 0
Physiotherapy and occupational therapy functional motor assessments
Timepoint [3] 299303 0
At weeks 1, 3 and 5 following inclusion and at weeks 1 and 8 after experimental intervention. Experimental intervention is administered during weeks 6 to 10 relative to inclusion.

Eligibility
Key inclusion criteria
(i) Quadriplegia elicited by traumatic SCI at the C6/C7 level
(ii) Complete infra-lesional motor deficit (score < 20/100 on the ASIA impairment scale) (iii) Time post-injury superior or equal to 6 months, with non-evolutive general, motor and sensory deficit
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Non-stabilized HTN or pathological autonomous nervous system dysfunction (e.g. orthostatic hypotension) (ii) Cerebral damage and/or cognitive deficit (iii) Elbow or shoulder joint amplitude restriction, upper limb para osteo-arthropathy (iv)Presence of metallic objects within the body (e.g. pacemaker, auditory device) incompatible with neuroimaging recordings (v) Participation to another research program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were hospitalized after traumatic cervical spinal cord injury. The head medical doctor responsible for patient's hospitalization and medical care delivery checked that participants met the inclusion criteria, and informed of the possibility to participate in a rehabilitation research program. Participants provided written informed consent according to the statements and principles of the Declaration of Helsinki.
Healthy control participants matched according to genre and age to the patients also participated in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SCI patients were systematically allocated to the treatment group. Healthy control participants matched according to genre and age to the patients were assigned to the control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to ethical reasons, we could not deprive voluntarily SCI patients from the treatment condition so as to constitute a patient control group. Indeed, there is a rich scientific background supporting the therapeutical relevance of motor imagery interventions in the management of motor rehabilitation in neurological populations.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 4564 0
France
State/province [1] 4564 0
Rhone Alpes

Funding & Sponsors
Funding source category [1] 286047 0
Hospital
Name [1] 286047 0
Hospices Civils de Lyon
Country [1] 286047 0
France
Primary sponsor type
University
Name
Universite Claude Bernard Lyon 1 - CRIS EA 647
Address
27-29 Boulevard du 11 Novembre 1918
69622 Villeurbanne Cedex
Country
France
Secondary sponsor category [1] 284860 0
Hospital
Name [1] 284860 0
Hopital Henri Gabrielle (Neurological Rehabilitation)
Address [1] 284860 0
20 Route de Vourles
69230, Saint Genis Laval
Country [1] 284860 0
France
Secondary sponsor category [2] 284861 0
Other Collaborative groups
Name [2] 284861 0
CERMEP Imagerie du vivant - Departement MEG
Address [2] 284861 0
Centre Hospitalier Le Vinatier
95 Boulevard Pinel
69500 Bron
Country [2] 284861 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288097 0
Comite de Protection des Personnes Sud-Est II
Ethics committee address [1] 288097 0
Ethics committee country [1] 288097 0
France
Date submitted for ethics approval [1] 288097 0
Approval date [1] 288097 0
01/04/2012
Ethics approval number [1] 288097 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34731 0
Address 34731 0
Country 34731 0
Phone 34731 0
Fax 34731 0
Email 34731 0
Contact person for public queries
Name 17978 0
Di Rienzo Franck
Address 17978 0
27-29 Boulevard du 11 Novembre
69622 Villeurbanne Cedex
Country 17978 0
France
Phone 17978 0
+33 4 72432734
Fax 17978 0
Email 17978 0
franck.di-rienzo@etu.univ-lyon1.fr
Contact person for scientific queries
Name 8906 0
Di Rienzo Franck
Address 8906 0
27-29 Boulevard du 11 Novembre
69622 Villeurbanne Cedex
Country 8906 0
France
Phone 8906 0
+33 4 72432734
Fax 8906 0
Email 8906 0
franck.di-rienzo@etu.univ-lyon1.fr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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