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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)

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ClinicalTrials.gov Identifier: NCT03686280
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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).

Condition or disease Intervention/treatment Phase
Stroke Sequelae Other: Clinical evaluation Other: Intervention - with Robot Other: Intervention - without Robot Other: quality of life assessment Other: assessment of the patient's satisfaction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Robot in combination with traditional reeducation Other: 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

Other: 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

Other: 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.

Other: assessment of the patient's satisfaction
An assessment of the patient's satisfaction with walking rehabilitation: Satisfaction index completed by the patient

Active Comparator: Standard rehabilitation Other: 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

Other: 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

Other: 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.

Other: assessment of the patient's satisfaction
An assessment of the patient's satisfaction with walking rehabilitation: Satisfaction index completed by the patient




Primary Outcome Measures :
  1. Berg Balance Scale score [ Time Frame: at 1 month ]

    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 :
  1. FAC [ Time Frame: at 1 month and at 3 months ]
    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).

  2. motor skills scores: Motricity Index [ Time Frame: at 1 month and at 3 months ]
    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).

  3. SIS [ Time Frame: at 1 month and at 3 months ]
    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.

  4. EVA [ Time Frame: At 1 month ]
    Assessment of patient satisfaction: EVA out of 10, Likert scale on 5 or 7

  5. PASS [ Time Frame: at 1 month and at 3 months ]

    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).


  6. WADE [ Time Frame: at 1 month and at 3 months ]
    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).

  7. TUG [ Time Frame: at 1 month and at 3 months ]
    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.

  8. Walking Test [ Time Frame: at 1 month and at 3 months ]

    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).


  9. Berg Balance Scale score [ Time Frame: at 3 months ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, aged at least 18 years and at most 80 years old
  • Weight less than 105 kg,
  • Size at least 140 cm and less than or equal to 190 cm
  • 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 expand admitted for reeducation of the walk following a neurological event inferior at 6 months
  • Single or multiple stroke.
  • Post stroke period: acute sub (3 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:

  • Patients under the age of 80 or over,
  • Weight greater than 105 kg (total maximum weight supported by the robot: 120 kg)
  • Size greater than 1.90 m (robot design)
  • Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty
  • Patients currently included in another research protocol
  • Refusal of the patient to participate in the study
  • Pregnant and lactating women,
  • with major cognitive or mood disorders,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686280


Contacts
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Contact: Isabelle BONAN, MD +33299289617 isabelle.bonan@chu-rennes.fr

Locations
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France
Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
Ploemeur, France, 56275
Contact: Pauline Coignard, MD    0297826060 ext +33    pcoignard@kerpape.mutualite56.fr   
CHU de Rennes
Rennes, France, 35033
Contact: Isabelle BONAN, MD    0299289617    isabelle.bonan@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03686280    
Other Study ID Numbers: 35RC16_9901_ROBOK2
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases