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

Rennes University Hospital2 sites in 1 country74 target enrollmentJanuary 13, 2021

ConditionsStroke Sequelae

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke Sequelae
Sponsor: Rennes University Hospital
Enrollment: 74
Locations: 2
Primary Endpoint: Gain in Berg Balance Scale score
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 13, 2021

End Date

July 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rennes University Hospital

Responsible Party

Sponsor

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

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.

Outcomes

Primary Outcomes

Gain in 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).