Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation
NCT ID: NCT03686280
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
74 participants
INTERVENTIONAL
2021-01-13
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Robot in combination with traditional reeducation
Clinical evaluation
A clinical evaluation of the balance and the walk: is carried out by one of the coordinating physiotherapists of the center where the patient realizes his rehabilitation. The latter performs, according to the functional level of the patient, the following tests: Berg balance scale, FAC, PASS, TUG, 10MWT, 6MWT, paretic lower limb traction index , LBA, SSA and SSV, measurement of spasticity and sensitivity(D0, D30 and D90)
Intervention - with Robot
16 sessions of 45 minutes of reeducation with robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
quality of life assessment
A quality of life assessment: SIS questionnaire completed by the patient, the results of which will be reported in the observation book by the coordinating physiotherapist who carried out the evaluations described above. (D0, D30 and D90)
An assessment of patient acceptance of robotic rehabilitation
An assessment of patient acceptance of robotic rehabilitation (for patients in the robot group): self-questionnaire to be filled in by the patient (before carrying out the gait tests in order to avoid influence the results) (D30 ans D90)
cognitive assessment
An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.
An evaluation of how to use the robot
An evaluation of the robot's modalities of use (for patients in the robot group): time of use, distance travelled, walking speed, exercise duration, percentage of regulated suspension, number of breaks, average length of breaks, total length of breaks. (D30)
Standard rehabilitation
Clinical evaluation
A clinical evaluation of the balance and the walk: is carried out by one of the coordinating physiotherapists of the center where the patient realizes his rehabilitation. The latter performs, according to the functional level of the patient, the following tests: Berg balance scale, FAC, PASS, TUG, 10MWT, 6MWT, paretic lower limb traction index , LBA, SSA and SSV, measurement of spasticity and sensitivity(D0, D30 and D90)
Intervention - without Robot
16 sessions of 45 minutes of reeducation without robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
quality of life assessment
A quality of life assessment: SIS questionnaire completed by the patient, the results of which will be reported in the observation book by the coordinating physiotherapist who carried out the evaluations described above. (D0, D30 and D90)
cognitive assessment
An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.
Interventions
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Clinical evaluation
A clinical evaluation of the balance and the walk: is carried out by one of the coordinating physiotherapists of the center where the patient realizes his rehabilitation. The latter performs, according to the functional level of the patient, the following tests: Berg balance scale, FAC, PASS, TUG, 10MWT, 6MWT, paretic lower limb traction index , LBA, SSA and SSV, measurement of spasticity and sensitivity(D0, D30 and D90)
Intervention - with Robot
16 sessions of 45 minutes of reeducation with robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
Intervention - without Robot
16 sessions of 45 minutes of reeducation without robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
quality of life assessment
A quality of life assessment: SIS questionnaire completed by the patient, the results of which will be reported in the observation book by the coordinating physiotherapist who carried out the evaluations described above. (D0, D30 and D90)
An assessment of patient acceptance of robotic rehabilitation
An assessment of patient acceptance of robotic rehabilitation (for patients in the robot group): self-questionnaire to be filled in by the patient (before carrying out the gait tests in order to avoid influence the results) (D30 ans D90)
cognitive assessment
An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.
An evaluation of how to use the robot
An evaluation of the robot's modalities of use (for patients in the robot group): time of use, distance travelled, walking speed, exercise duration, percentage of regulated suspension, number of breaks, average length of breaks, total length of breaks. (D30)
Eligibility Criteria
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Inclusion Criteria
-Size at least equal to 150 cm and less than or equal to 190 cm (robot design)
* Having signed free informed consent in writing,
* Personal history of stroke with ischemic or hemorrhagic cause, right or left hemispherical, localized in addition or under tentorial
* Single or multiple stroke.
* Post stroke period: acute sub (2 weeks 6 months)
* Left or right hemiparesis resulting from stroke
* Gait or balance disorders related to the consequences of stroke
* Minimum Berg Score: 3
* Hospitalization in a CPR service in complete hospitalization, week or day
* Medical stability, ie not presenting a cardiovascular, biological or other imbalance against the rehabilitation of walking
* Patient affiliated to a social security scheme
Exclusion Criteria
* Patient with a very open wound
* Weight less than 40 kg
* Weight greater than 105 kg (total maximum weight supported by the robot: 120 kg)
\- FAC \> 4 and lack of technical aids for walking (e.g., single cane, tripod cane, rollator).
* Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty
* Patients currently included in another research protocol with an influence on balance and walking
* Refusal of the patient to participate in the study
* Pregnant and lactating women,
* with major cognitive or mood disorders, - Being unable to give their consent.
18 Years
80 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
Ploemeur, , France
CHU de Rennes
Rennes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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35RC16_9901_ROBOK2
Identifier Type: -
Identifier Source: org_study_id
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