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Stroke SequelaeROBOK2NCT03686280

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

A study testing Clinical evaluation, Intervention - with Robot and Intervention - without Robot in people with Stroke Sequelae, run by Rennes University Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke Sequelae
What is being tested?
Clinical evaluation, Intervention - with Robot and Intervention - without Robot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesFrance
Study dates
13 Jan 2021to 28 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites
  • Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape

    Ploemeur, 56275

  • CHU de Rennes

    Rennes, 35033

Other trials in France

About this study

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).

Conditions
Stroke Sequelae
Being tested
Clinical evaluation, Intervention - with Robot, Intervention - without Robot, quality of life assessment, An assessment of patient acceptance of robotic rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical evaluationOther

    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 RobotOther

    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 RobotOther

    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 assessmentOther

    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 rehabilitationOther

    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 assessmentOther

    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 robotOther

    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)

Study groups in NCT03686280
Study groupRoleWhat they receive
Robot in combination with traditional reeducationExperimentalNot described
Receives: Other: Clinical evaluation; Other: Intervention - with Robot; Other: quality of life assessment; Other: An assessment of patient acceptance of robotic rehabilitation; Other: cognitive assessment; Other: An evaluation of how to use the robot
Standard rehabilitationActive comparatorNot described
Receives: Other: Clinical evaluation; Other: Intervention - without Robot; Other: quality of life assessment; Other: cognitive assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: at 1 month

Secondary outcomes (28)
  1. 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).

    Measured: at 1 month and at 3 months

  2. 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).

    Measured: at 1 month and at 3 months

  3. 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.

    Measured: at 1 month and at 3 months

  4. 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).

    Measured: at 1 month and at 3 months

  5. 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).

    Measured: at 1 month and at 3 months

  6. 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.

    Measured: at 1 month and at 3 months

  7. 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).

    Measured: at 1 month and at 3 months

  8. 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).

    Measured: at 3 months

  9. 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.

    Measured: At 1 month

  10. 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.

    Measured: At 1 month

  11. 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.

    Measured: At 3 months

  12. Evaluation of the robot's modalities of use - Time

    Time of use Time of use

    Measured: At 1 month

  13. Evaluation of the robot's modalities of use - Distance

    Distance travelled

    Measured: At 1 month

  14. Evaluation of the robot's modalities of use - Speed

    Walking speed

    Measured: At 1 month

  15. Evaluation of the robot's modalities of use - Duration

    Duration of the exercise

    Measured: At 1 month

  16. Evaluation of the robot's modalities of use - Suspension

    Regulated suspension percentage

    Measured: At 1 month

  17. Evaluation of the robot's modalities of use - Breaks

    Number of breaks

    Measured: At 1 month

  18. Evaluation of the robot's modalities of use - Lengh

    Average lengh of breaks

    Measured: At 1 month

  19. Evaluation of the robot's modalities of use - duration breaks

    Total duration of breaks

    Measured: At 1 month

  20. 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).

    Measured: At 1 month

  21. 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).

    Measured: At 1 month

  22. 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.

    Measured: At 1 month

  23. 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.

    Measured: At 1 month

  24. Evaluation of cognitive functions - Bell barrage test

    Bell barrage test

    Measured: At 1 month

  25. Evaluation of cognitive functions - Bergego

    Catherine Bergego ladder

    Measured: At 1 month

  26. Evolution of spatial reference frames - SSA

    Subjective Straight Ahead (SSA) haptique,

    Measured: At 1 month and at 3 months

  27. Evolution of spatial reference frames - SSV

    Subjective Visual Vertical (SVV),

    Measured: At 1 month and at 3 months

  28. Evolution of spatial reference frames - LBA

    Longitudinal Body Axis (LBA)

    Measured: At 1 month and at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2018
  2. Study start13 Jan 2021
  3. Primary completion28 Jul 2023
  4. Study completion28 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03686280
Sponsor's protocol ID
35RC16_9901_ROBOK2
Acronym
ROBOK2
Status last verified
Jun 2026
First submitted
20 Sep 2018
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical evaluation, Intervention - with Robot and Intervention - without Robot in people with Stroke Sequelae, run by Rennes University Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gain in Berg Balance Scale score (time frame: at 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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