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

NCT03686280 | Completed

• 1 other identifier: 35RC16_9901_ROBOK2
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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).

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (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).

  at 1 month

Secondary Outcomes (28)

• FAC

  at 1 month and at 3 months

• motor skills scores: Motricity Index

  at 1 month and at 3 months

• SIS

  at 1 month and at 3 months

• PASS

  at 1 month and at 3 months

• WADE

  at 1 month and at 3 months

Study Arms (2)

Robot in combination with traditional reeducation

EXPERIMENTAL

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 rehabilitation

ACTIVE COMPARATOR

Other: Clinical evaluation; Other: Intervention - without Robot; Other: quality of life assessment; Other: cognitive assessment

Interventions

Intervention - with Robot OTHER

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

Robot in combination with traditional reeducation

Intervention - without Robot OTHER

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

Standard rehabilitation

cognitive assessment OTHER

An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.

Robot in combination with traditional reeducation; Standard rehabilitation

Clinical evaluation OTHER

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)

Robot in combination with traditional reeducation; Standard rehabilitation

quality of life assessment OTHER

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)

Robot in combination with traditional reeducation; Standard rehabilitation

An assessment of patient acceptance of robotic rehabilitation OTHER

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)

Robot in combination with traditional reeducation

An evaluation of how to use the robot OTHER

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)

Robot in combination with traditional reeducation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape

Ploemeur, 56275, France

Location

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Methods; Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 26, 2018
• Study Start: January 13, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (2)