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

Rennes University Hospital

Status: Unknown

Conditions: Stroke Sequelae

Treatments: Other: Clinical evaluation; Other: An assessment of patient acceptance of robotic rehabilitation; Other: An evaluation of how to use the robot; Other: Intervention - without Robot; Other: Intervention - with Robot; Other: cognitive assessment; Other: quality of life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03686280

35RC16_9901_ROBOK2

Details and patient eligibility

About

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).

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Robot in combination with traditional reeducation

Experimental group

Treatment:

Other: quality of life assessment

Other: cognitive assessment

Other: Intervention - with Robot

Other: An assessment of patient acceptance of robotic rehabilitation

Other: Clinical evaluation

Other: An evaluation of how to use the robot

Standard rehabilitation

Active Comparator group

Treatment:

Other: quality of life assessment

Other: cognitive assessment

Other: Intervention - without Robot

Other: Clinical evaluation