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Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation (ROBOK2)

Primary Purpose

Stroke Sequelae

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical evaluation
Intervention - with Robot
Intervention - without Robot
quality of life assessment
An assessment of patient acceptance of robotic rehabilitation
cognitive assessment
An evaluation of how to use the robot
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke Sequelae

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
  • CHU de RennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot in combination with traditional reeducation

Standard rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Gain in Berg Balance Scale score
It consists of 14 items, with a maximum score of 56. Static and dynamic balance tasks of increasing difficulty are performed, with a score per item ranging from 0 to 4, depending on the ability to perform the task evaluated. This equilibrium scale was initially conceived as a quantitative measure of the balance and the risk of falling in non-institutionalized elderly people (Berg 1989). The psychometric qualities of this scale were then demonstrated in patients after stroke, including fidelity, validity and internal consistency (Berg 1992, Berg 1995, Mao 2002, Wang 2004, Hiengkaew 2012). Sensitivity to change was considered moderate to wide according to the studies (Wood-Dauphinee 1996, Mao 2002, Chou 2006). The Standard Error of Measurement (SEM) varies from 1.5 to 2.9 points depending on the studies (Liston and Brouwer 1996, Stevensen 2001, Flansbjer 2012, Hiengkaew 2012).

Secondary Outcome Measures

FAC
FAC is a functional classification of walking that assesses a patient's ability to move. This six-point scale assesses the state of the walk by determining the human support the patient needs to walk, whether or not he / she uses a personal assistive device (Teasell, Foley & Salter, 2011). The psychometric qualities of the FAC were evaluated in post stroke patients by Mehrholz in 2007: excellent fidelity, good sensitivity to change, adequate predictive validity and excellent concomitant validity. However, significant ceiling effects have been reported (Salter 2008).
motor skills scores: Motricity Index
The motricity index, Motricity Index, is an ordinal method of measuring muscle strength developed by Demeurisse in 1980. In the lower limb, 3 movements are tested and performed in a sitting position: hip flexion, knee extension and dorsiflexion. For each movement, the score is 0.9, 14.19, 25 or 33 (same items as the MRC classification on 5). The maximum total score in the lower limb is therefore 99. The evaluation is made on the side of the paretic limb. This scale has excellent fidelity (Collin and Wade 1990, Fayazi 2012) and construct validity (Collin and Wade 1990). The susceptibility to change in the motor index is average, and for example the TDM10m is more sensitive to change than the motor index (Vos-Vromans 2005).
SIS
Stroke Impact Scale (SIS) is a quality of life assessment tool. Its latest version, SIS 3.0, contains 59 items (64 for version 2.0) measuring eight domains: strength (4 items), hand functionality (5 items), ADL / IADL (10 items), mobility ( 9 items), communication (7 items), emotions (9 items), memory / thinking (7 items), and social participation (8 items). A final item assessing overall recovery from stroke is requested from the patient (score out of 100).The items are scored using a Likert type scale with five answer options. Patients are asked to complete the instrument according to the difficulty they perceived during the last week. The scores of 5, 4, 3, 2 and 1 correspond respectively to: '' not difficult at all '', '' a little difficult '', '' rather difficult '', '' very difficult '', and '' extremely difficult ''. The scores are then processed by computer to obtain a total score out of 100, 100 corresponding to the absence of difficulty.
PASS
Postural Assesment Scale: The PASS, Postural Assesment Scale, assesses balance in a supine, sitting and standing position. this scale has been designed specifically for stroke patients and is suitable for all individuals regardless of postural performance (Benaim 1999). It is an adaptation of the Fugl-Meyer evaluation equilibrium subscale. Initially developed in French, it was later translated into English. This scale consists of 12 items of increasing difficulty. It includes items not evaluated by the Berg / BBS scale (Blum and Korner-Bitensky, 2008) and demonstrates better psychometric properties than the Berg / BBS scale and the modified balance subscale of the evaluation. Fugl-Meyer (Mao 2002, Hsieh 2002, Wang 2004).
WADE
The Wade test, or 10-meter walk test (TDM10m), is designed to evaluate walking speed per second over a short distance. The patient walks for 10 meters, and the time required to cover this distance is measured, and the number of steps is calculated. Most often the patient is started, that is to say he starts a few meters before and he starts the test at constant speed. Three in-line tests must be performed, and the average over the three trials is calculated. The test can be done at comfortable speed or fast speed (must be specified), with or without technical assistance (walking stick, walker), with or without orthosis (foot lifter, orthopedic shoes). The Standard Error of Measurement (SEM) was evaluated at 0.04 m / sec (Perera 2006), and the Minimum Detectable Change-MDC at 0.16 m / sec (Tilson 2010). The cut-off for safe outdoor independent walking has been set at 0.8 m / s (Bowden 2008).
TUG
TUG, Timed Up and Go Test (Podsiadlo and Richardson, 1991), is an instrument for the overall assessment of mobility, balance, walking ability and risk of falling in the elderly. The patient should stand up from a chair, walk a distance of three meters, turn around, then return to the chair while walking and sitting down. These tasks must be performed at comfortable speed. The measured time begins with the verbal instruction "go" and stops when the client returns to sitting position. It is permissible to use a walking aid, but its use must be indicated. No physical assistance is given. TUG performance is rated on a scale of 1 to 5, where 1 indicates "normal functioning" and 5 indicates "severe abnormal behavior", depending on the individual's perception of risk of falling. The score is the time taken to complete the test, in seconds.
Walking Test
Walking test of 6 minutes: The six-minute walk test (6MWT / TDM6min) (Butland, Pang, Gross, Woodcock and Geddes, 1982) is a functional walk test in which the distance traveled by the patient in six minutes is evaluated. This test has been validated in different populations including stroke patients (Kosak and Smith, 2005). It is a simple test that requires an indoor, straight, flat, 30m long corridor. Mean normative data vary between 408 and 422 m (Wevers 2011). Standard Error of Measurement (SEM) has been estimated to be between 12.4 and 18.6 m (Eng 2004, Flansbjer 2005), and the Minimal Detectable Change-MDC at about 35 m for a population chronic stroke (Eng 2004, Flansbjer 2005) and 61 m in the acute phase (Perera 2006). Fidelity has been found by studies to be excellent (Flansbjer 2005, Fulk 2008, Wevers 2011) or adequate (Kosak and Smith 2005). Validity against excellent criteria (Flansbjer 2005, Kosak and Smith 2005, Wevers 2011).
Berg Balance Scale score
It consists of 14 items, with a maximum score of 56. Static and dynamic balance tasks of increasing difficulty are performed, with a score per item ranging from 0 to 4, depending on the ability to perform the task evaluated. This equilibrium scale was initially conceived as a quantitative measure of the balance and the risk of falling in non-institutionalized elderly people (Berg 1989). The psychometric qualities of this scale were then demonstrated in patients after stroke, including fidelity, validity and internal consistency (Berg 1992, Berg 1995, Mao 2002, Wang 2004, Hiengkaew 2012). Sensitivity to change was considered moderate to wide according to the studies (Wood-Dauphinee 1996, Mao 2002, Chou 2006). The Standard Error of Measurement (SEM) varies from 1.5 to 2.9 points depending on the studies (Liston and Brouwer 1996, Stevensen 2001, Flansbjer 2012, Hiengkaew 2012).
Evaluation of cognitive functions
The MMSE, Mini Mental State Examination, is a tool for assessing global cognitive efficiency (Folstein and Folstein, 1975).The MMSE (Boxes 1 and 2) consists of a series of questions grouped into 7 subtests and designed in such a way that normal subjects can easily answer each question. The questions concern: orientation in time (5 points), orientation in space (5 points), immediate recall of three words (3 points), attention (5 points), delayed recall of three words (3 points), language (8 points) and constructive praxis (1 point). The maximum score is therefore 30 points.
Evaluation of patient acceptance of robotic gait rehabilitation
Evaluation of patient acceptance of robotic gait rehabilitation at 1 month (D30± 5 days): Acceptance questionnaire, developed by our laboratory colleagues of Social Psychology, LP3C, University of Rennes 2.
Evaluation of patient acceptance of robotic gait rehabilitation
Evaluation of patient acceptance of robotic gait rehabilitation at 3 months (D90 ± 2 days): Acceptance questionnaire, developed by our laboratory colleagues of Social Psychology, LP3C, University of Rennes 2.
Evaluation of the robot's modalities of use - Time
Time of use Time of use
Evaluation of the robot's modalities of use - Distance
Distance travelled
Evaluation of the robot's modalities of use - Speed
Walking speed
Evaluation of the robot's modalities of use - Duration
Duration of the exercise
Evaluation of the robot's modalities of use - Suspension
Regulated suspension percentage
Evaluation of the robot's modalities of use - Breaks
Number of breaks
Evaluation of the robot's modalities of use - Lengh
Average lengh of breaks
Evaluation of the robot's modalities of use - duration breaks
Total duration of breaks
Evaluation of cognitive functions - BREF
BREF(Batterie Rapide d'Efficience Frontale) or FAB (Frontal Assessment Battery in english is a neuropsychological evaluation of executive functions developed by Dubois and Pillon in 2000. It is a rapid test (between 5 and 10 minutes) and is composed of 6 sub-tests: similarities (exploring conceptual elaboration), lexical evocation (exploring mental flexibility), Luria's gesture sequence (exploring programming), conflicting instructions (exploring sensitivity to interference), the Go-No Go (exploring inhibitory control) and the search for a grasping behavior (exploring behavioral autonomy with respect to the environment). The BREF is the most widely used screening tool for examining executive functions, due to its sensitivity. The cut-off score is 16 for levels 2 and 3, and 15 for level 1 (below the school leaving certificate).
Evaluation of cognitive functions - TMT
The TMT B, Trail Making Test Part B (Reitan, 1958).In part B of the TMT (TMT-B), the sheet given to the subject includes 13 circles containing numbers from 1 to 13 and 12 circles containing letters from A to L, distributed in a semi-random way on the page. The subject is instructed to connect, as quickly as possible, the numbers and letters in their respective order, alternating each time between a number and a letter. Any errors are not corrected by the examiner. A pre-test containing six items to be connected is carried out beforehand, in order to make sure that the instructions have been understood. The number of correct moves and the time taken to complete the task are collected. The French norms of the TMT B were made available by the GREFEX (Groupe D'Evaluation des Fonctions Exécutives).
Evaluation of cognitive functions - VAP-S
The Virtual Action Planning Supermarket (VAP-S) consists of a medium-sized supermarket. The task is to collect 7 items in the supermarket according to a predefined list, then to check out, pay and leave the store. The software allows the collection of the following data: the total distance traveled (in meters), the time (in seconds) needed by the subject to accomplish the task, the number of products purchased, the number of correct actions, the number of incorrect actions (intrusions and perseverations), the number of pauses (greater than 3 seconds), the total duration of the pauses (in seconds), the collisions inside the supermarket The composite score of time per object weighted by the number of objects found ((time/number of objects found)/(number of objects found/7)) has already been validated and published in several studies (Cogné et al., 2016; 2018) and has been shown to be highly correlated with executive functions assessed using paper-and-pencil tests and questionnaires.
Evaluation of cognitive functions- Memory Test
Memory test: RL/RI-16: The RL/RI-16, or 16-item free recall/indexed recall test The word list consists of 16 words belonging to 16 semantic categories. The task starts with a categorical semantic encoding phase. Then, an immediate recall, three free/indicative recalls and a delayed free/indicative recall are performed. The aim of this procedure is to elicit effective encoding and retrieval strategies in a patient while monitoring the effective implementation of these strategies. Several studies have shown the usefulness of this procedure in distinguishing demented patients from normal elderly subjects (Christensen et al. 1991; Grober et al., 1988; Grober and Kawas, 1997; Petersen et al., 1994). This test is widely used throughout the world, and has been used extensively in various studies assessing memory in brain-damaged subjects. The duration of the encoding and immediate recall phase is about 10 minutes, and that of delayed recall 3-4 minutes.
Evaluation of cognitive functions - Bell barrage test
Bell barrage test
Evaluation of cognitive functions - Bergego
Catherine Bergego ladder
Evolution of spatial reference frames - SSA
Subjective Straight Ahead (SSA) haptique,
Evolution of spatial reference frames - SSV
Subjective Visual Vertical (SVV),
Evolution of spatial reference frames - LBA
Longitudinal Body Axis (LBA)

Full Information

First Posted
September 20, 2018
Last Updated
April 26, 2021
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03686280
Brief Title
Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation
Acronym
ROBOK2
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot in combination with traditional reeducation
Arm Type
Experimental
Arm Title
Standard rehabilitation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Clinical evaluation
Intervention Description
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 Type
Other
Intervention Name(s)
Intervention - with Robot
Intervention Description
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 Type
Other
Intervention Name(s)
Intervention - without Robot
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
quality of life assessment
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
An assessment of patient acceptance of robotic rehabilitation
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
cognitive assessment
Intervention Description
An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.
Intervention Type
Other
Intervention Name(s)
An evaluation of how to use the robot
Intervention Description
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)
Primary Outcome Measure Information:
Title
Gain in Berg Balance Scale score
Description
It consists of 14 items, with a maximum score of 56. Static and dynamic balance tasks of increasing difficulty are performed, with a score per item ranging from 0 to 4, depending on the ability to perform the task evaluated. This equilibrium scale was initially conceived as a quantitative measure of the balance and the risk of falling in non-institutionalized elderly people (Berg 1989). The psychometric qualities of this scale were then demonstrated in patients after stroke, including fidelity, validity and internal consistency (Berg 1992, Berg 1995, Mao 2002, Wang 2004, Hiengkaew 2012). Sensitivity to change was considered moderate to wide according to the studies (Wood-Dauphinee 1996, Mao 2002, Chou 2006). The Standard Error of Measurement (SEM) varies from 1.5 to 2.9 points depending on the studies (Liston and Brouwer 1996, Stevensen 2001, Flansbjer 2012, Hiengkaew 2012).
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
FAC
Description
FAC is a functional classification of walking that assesses a patient's ability to move. This six-point scale assesses the state of the walk by determining the human support the patient needs to walk, whether or not he / she uses a personal assistive device (Teasell, Foley & Salter, 2011). The psychometric qualities of the FAC were evaluated in post stroke patients by Mehrholz in 2007: excellent fidelity, good sensitivity to change, adequate predictive validity and excellent concomitant validity. However, significant ceiling effects have been reported (Salter 2008).
Time Frame
at 1 month and at 3 months
Title
motor skills scores: Motricity Index
Description
The motricity index, Motricity Index, is an ordinal method of measuring muscle strength developed by Demeurisse in 1980. In the lower limb, 3 movements are tested and performed in a sitting position: hip flexion, knee extension and dorsiflexion. For each movement, the score is 0.9, 14.19, 25 or 33 (same items as the MRC classification on 5). The maximum total score in the lower limb is therefore 99. The evaluation is made on the side of the paretic limb. This scale has excellent fidelity (Collin and Wade 1990, Fayazi 2012) and construct validity (Collin and Wade 1990). The susceptibility to change in the motor index is average, and for example the TDM10m is more sensitive to change than the motor index (Vos-Vromans 2005).
Time Frame
at 1 month and at 3 months
Title
SIS
Description
Stroke Impact Scale (SIS) is a quality of life assessment tool. Its latest version, SIS 3.0, contains 59 items (64 for version 2.0) measuring eight domains: strength (4 items), hand functionality (5 items), ADL / IADL (10 items), mobility ( 9 items), communication (7 items), emotions (9 items), memory / thinking (7 items), and social participation (8 items). A final item assessing overall recovery from stroke is requested from the patient (score out of 100).The items are scored using a Likert type scale with five answer options. Patients are asked to complete the instrument according to the difficulty they perceived during the last week. The scores of 5, 4, 3, 2 and 1 correspond respectively to: '' not difficult at all '', '' a little difficult '', '' rather difficult '', '' very difficult '', and '' extremely difficult ''. The scores are then processed by computer to obtain a total score out of 100, 100 corresponding to the absence of difficulty.
Time Frame
at 1 month and at 3 months
Title
PASS
Description
Postural Assesment Scale: The PASS, Postural Assesment Scale, assesses balance in a supine, sitting and standing position. this scale has been designed specifically for stroke patients and is suitable for all individuals regardless of postural performance (Benaim 1999). It is an adaptation of the Fugl-Meyer evaluation equilibrium subscale. Initially developed in French, it was later translated into English. This scale consists of 12 items of increasing difficulty. It includes items not evaluated by the Berg / BBS scale (Blum and Korner-Bitensky, 2008) and demonstrates better psychometric properties than the Berg / BBS scale and the modified balance subscale of the evaluation. Fugl-Meyer (Mao 2002, Hsieh 2002, Wang 2004).
Time Frame
at 1 month and at 3 months
Title
WADE
Description
The Wade test, or 10-meter walk test (TDM10m), is designed to evaluate walking speed per second over a short distance. The patient walks for 10 meters, and the time required to cover this distance is measured, and the number of steps is calculated. Most often the patient is started, that is to say he starts a few meters before and he starts the test at constant speed. Three in-line tests must be performed, and the average over the three trials is calculated. The test can be done at comfortable speed or fast speed (must be specified), with or without technical assistance (walking stick, walker), with or without orthosis (foot lifter, orthopedic shoes). The Standard Error of Measurement (SEM) was evaluated at 0.04 m / sec (Perera 2006), and the Minimum Detectable Change-MDC at 0.16 m / sec (Tilson 2010). The cut-off for safe outdoor independent walking has been set at 0.8 m / s (Bowden 2008).
Time Frame
at 1 month and at 3 months
Title
TUG
Description
TUG, Timed Up and Go Test (Podsiadlo and Richardson, 1991), is an instrument for the overall assessment of mobility, balance, walking ability and risk of falling in the elderly. The patient should stand up from a chair, walk a distance of three meters, turn around, then return to the chair while walking and sitting down. These tasks must be performed at comfortable speed. The measured time begins with the verbal instruction "go" and stops when the client returns to sitting position. It is permissible to use a walking aid, but its use must be indicated. No physical assistance is given. TUG performance is rated on a scale of 1 to 5, where 1 indicates "normal functioning" and 5 indicates "severe abnormal behavior", depending on the individual's perception of risk of falling. The score is the time taken to complete the test, in seconds.
Time Frame
at 1 month and at 3 months
Title
Walking Test
Description
Walking test of 6 minutes: The six-minute walk test (6MWT / TDM6min) (Butland, Pang, Gross, Woodcock and Geddes, 1982) is a functional walk test in which the distance traveled by the patient in six minutes is evaluated. This test has been validated in different populations including stroke patients (Kosak and Smith, 2005). It is a simple test that requires an indoor, straight, flat, 30m long corridor. Mean normative data vary between 408 and 422 m (Wevers 2011). Standard Error of Measurement (SEM) has been estimated to be between 12.4 and 18.6 m (Eng 2004, Flansbjer 2005), and the Minimal Detectable Change-MDC at about 35 m for a population chronic stroke (Eng 2004, Flansbjer 2005) and 61 m in the acute phase (Perera 2006). Fidelity has been found by studies to be excellent (Flansbjer 2005, Fulk 2008, Wevers 2011) or adequate (Kosak and Smith 2005). Validity against excellent criteria (Flansbjer 2005, Kosak and Smith 2005, Wevers 2011).
Time Frame
at 1 month and at 3 months
Title
Berg Balance Scale score
Description
It consists of 14 items, with a maximum score of 56. Static and dynamic balance tasks of increasing difficulty are performed, with a score per item ranging from 0 to 4, depending on the ability to perform the task evaluated. This equilibrium scale was initially conceived as a quantitative measure of the balance and the risk of falling in non-institutionalized elderly people (Berg 1989). The psychometric qualities of this scale were then demonstrated in patients after stroke, including fidelity, validity and internal consistency (Berg 1992, Berg 1995, Mao 2002, Wang 2004, Hiengkaew 2012). Sensitivity to change was considered moderate to wide according to the studies (Wood-Dauphinee 1996, Mao 2002, Chou 2006). The Standard Error of Measurement (SEM) varies from 1.5 to 2.9 points depending on the studies (Liston and Brouwer 1996, Stevensen 2001, Flansbjer 2012, Hiengkaew 2012).
Time Frame
at 3 months
Title
Evaluation of cognitive functions
Description
The MMSE, Mini Mental State Examination, is a tool for assessing global cognitive efficiency (Folstein and Folstein, 1975).The MMSE (Boxes 1 and 2) consists of a series of questions grouped into 7 subtests and designed in such a way that normal subjects can easily answer each question. The questions concern: orientation in time (5 points), orientation in space (5 points), immediate recall of three words (3 points), attention (5 points), delayed recall of three words (3 points), language (8 points) and constructive praxis (1 point). The maximum score is therefore 30 points.
Time Frame
At 1 month
Title
Evaluation of patient acceptance of robotic gait rehabilitation
Description
Evaluation of patient acceptance of robotic gait rehabilitation at 1 month (D30± 5 days): Acceptance questionnaire, developed by our laboratory colleagues of Social Psychology, LP3C, University of Rennes 2.
Time Frame
At 1 month
Title
Evaluation of patient acceptance of robotic gait rehabilitation
Description
Evaluation of patient acceptance of robotic gait rehabilitation at 3 months (D90 ± 2 days): Acceptance questionnaire, developed by our laboratory colleagues of Social Psychology, LP3C, University of Rennes 2.
Time Frame
At 3 months
Title
Evaluation of the robot's modalities of use - Time
Description
Time of use Time of use
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - Distance
Description
Distance travelled
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - Speed
Description
Walking speed
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - Duration
Description
Duration of the exercise
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - Suspension
Description
Regulated suspension percentage
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - Breaks
Description
Number of breaks
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - Lengh
Description
Average lengh of breaks
Time Frame
At 1 month
Title
Evaluation of the robot's modalities of use - duration breaks
Description
Total duration of breaks
Time Frame
At 1 month
Title
Evaluation of cognitive functions - BREF
Description
BREF(Batterie Rapide d'Efficience Frontale) or FAB (Frontal Assessment Battery in english is a neuropsychological evaluation of executive functions developed by Dubois and Pillon in 2000. It is a rapid test (between 5 and 10 minutes) and is composed of 6 sub-tests: similarities (exploring conceptual elaboration), lexical evocation (exploring mental flexibility), Luria's gesture sequence (exploring programming), conflicting instructions (exploring sensitivity to interference), the Go-No Go (exploring inhibitory control) and the search for a grasping behavior (exploring behavioral autonomy with respect to the environment). The BREF is the most widely used screening tool for examining executive functions, due to its sensitivity. The cut-off score is 16 for levels 2 and 3, and 15 for level 1 (below the school leaving certificate).
Time Frame
At 1 month
Title
Evaluation of cognitive functions - TMT
Description
The TMT B, Trail Making Test Part B (Reitan, 1958).In part B of the TMT (TMT-B), the sheet given to the subject includes 13 circles containing numbers from 1 to 13 and 12 circles containing letters from A to L, distributed in a semi-random way on the page. The subject is instructed to connect, as quickly as possible, the numbers and letters in their respective order, alternating each time between a number and a letter. Any errors are not corrected by the examiner. A pre-test containing six items to be connected is carried out beforehand, in order to make sure that the instructions have been understood. The number of correct moves and the time taken to complete the task are collected. The French norms of the TMT B were made available by the GREFEX (Groupe D'Evaluation des Fonctions Exécutives).
Time Frame
At 1 month
Title
Evaluation of cognitive functions - VAP-S
Description
The Virtual Action Planning Supermarket (VAP-S) consists of a medium-sized supermarket. The task is to collect 7 items in the supermarket according to a predefined list, then to check out, pay and leave the store. The software allows the collection of the following data: the total distance traveled (in meters), the time (in seconds) needed by the subject to accomplish the task, the number of products purchased, the number of correct actions, the number of incorrect actions (intrusions and perseverations), the number of pauses (greater than 3 seconds), the total duration of the pauses (in seconds), the collisions inside the supermarket The composite score of time per object weighted by the number of objects found ((time/number of objects found)/(number of objects found/7)) has already been validated and published in several studies (Cogné et al., 2016; 2018) and has been shown to be highly correlated with executive functions assessed using paper-and-pencil tests and questionnaires.
Time Frame
At 1 month
Title
Evaluation of cognitive functions- Memory Test
Description
Memory test: RL/RI-16: The RL/RI-16, or 16-item free recall/indexed recall test The word list consists of 16 words belonging to 16 semantic categories. The task starts with a categorical semantic encoding phase. Then, an immediate recall, three free/indicative recalls and a delayed free/indicative recall are performed. The aim of this procedure is to elicit effective encoding and retrieval strategies in a patient while monitoring the effective implementation of these strategies. Several studies have shown the usefulness of this procedure in distinguishing demented patients from normal elderly subjects (Christensen et al. 1991; Grober et al., 1988; Grober and Kawas, 1997; Petersen et al., 1994). This test is widely used throughout the world, and has been used extensively in various studies assessing memory in brain-damaged subjects. The duration of the encoding and immediate recall phase is about 10 minutes, and that of delayed recall 3-4 minutes.
Time Frame
At 1 month
Title
Evaluation of cognitive functions - Bell barrage test
Description
Bell barrage test
Time Frame
At 1 month
Title
Evaluation of cognitive functions - Bergego
Description
Catherine Bergego ladder
Time Frame
At 1 month
Title
Evolution of spatial reference frames - SSA
Description
Subjective Straight Ahead (SSA) haptique,
Time Frame
At 1 month and at 3 months
Title
Evolution of spatial reference frames - SSV
Description
Subjective Visual Vertical (SVV),
Time Frame
At 1 month and at 3 months
Title
Evolution of spatial reference frames - LBA
Description
Longitudinal Body Axis (LBA)
Time Frame
At 1 month and at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle BONAN, MD
Phone
+33299289617
Email
isabelle.bonan@chu-rennes.fr
Facility Information:
Facility Name
Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
City
Ploemeur
ZIP/Postal Code
56275
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Coignard, MD
Phone
0297826060
Ext
+33
Email
pcoignard@kerpape.mutualite56.fr
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle BONAN, MD
Phone
0299289617
Email
isabelle.bonan@chu-rennes.fr

12. IPD Sharing Statement

Learn more about this trial

Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation

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