Clinical trial NCT03686280: Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation
Official title: Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Sequelae
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed. Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . This project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The aim of the study is to study the effectiveness of the prototype (interactive walking mobile robot).


Eligibility criteria: Inclusion Criteria:

* Male and female patients, aged at least 18 years and at most 80 years old

  -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 pacemaker

  * 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.

Primary outcomes:
measure: Gain in Berg Balance Scale score
timeFrame: at 1 month
Secondary outcomes:
measure: FAC
timeFrame: at 1 month and at 3 months
measure: motor skills scores: Motricity Index
timeFrame: at 1 month and at 3 months
measure: SIS
timeFrame: at 1 month and at 3 months
measure: PASS
timeFrame: at 1 month and at 3 months
measure: WADE
timeFrame: at 1 month and at 3 months
measure: TUG
timeFrame: at 1 month and at 3 months
measure: Walking Test
timeFrame: at 1 month and at 3 months
measure: Berg Balance Scale score
timeFrame: at 3 months
measure: Evaluation of cognitive functions
timeFrame: At 1 month
measure: Evaluation of patient acceptance of robotic gait rehabilitation
timeFrame: At 1 month
measure: Evaluation of patient acceptance of robotic gait rehabilitation
timeFrame: At 3 months
measure: Evaluation of the robot's modalities of use - Time
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - Distance
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - Speed
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - Duration
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - Suspension
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - Breaks
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - Lengh
timeFrame: At 1 month
measure: Evaluation of the robot's modalities of use - duration breaks
timeFrame: At 1 month
measure: Evaluation of cognitive functions - BREF
timeFrame: At 1 month
measure: Evaluation of cognitive functions - TMT
timeFrame: At 1 month
measure: Evaluation of cognitive functions - VAP-S
timeFrame: At 1 month
measure: Evaluation of cognitive functions- Memory Test
timeFrame: At 1 month
measure: Evaluation of cognitive functions - Bell barrage test
timeFrame: At 1 month
measure: Evaluation of cognitive functions - Bergego
timeFrame: At 1 month
measure: Evolution of spatial reference frames - SSA
timeFrame: At 1 month and at 3 months
measure: Evolution of spatial reference frames - SSV
timeFrame: At 1 month and at 3 months
measure: Evolution of spatial reference frames - LBA
timeFrame: At 1 month and at 3 months
Other outcomes:
Locations:
city: Ploemeur
country: France
facility: Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: