Technological Balance and Gait Rehabilitation in Patients With Stroke Sequelae: Functional, Motor and Cognitive Outcomes (ROAR-S)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Balance; Stroke; Gait Disorders, Neurologic

Treatments: Device: Technological Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05280587

0003731/22

Details and patient eligibility

About

Stroke represents the leading cause of disability worldwide, with a significant impact on an individual, family, and economic impact. The recovery of smoother, safer, and more correct walking is an essential requirement to allow the patient to regain autonomy in the activities of daily living. Some preliminary studies have shown that robotic training of the gait training has influenced the functional and motor outcome in patients with stroke outcomes an improvement in endurance and walking strategies was observed. In addition, frequently, a stroke involves an alteration of the cognitive system that contributes to the deterioration of balance and gait during dual-task activities; the study of these processes can be of interest for rehabilitation purposes. Considering these preliminary data and that the patient must continuously find balance in overground walking, it is believed that a robotic balance treatment associated with conventional therapy may be more effective than conventional therapy alone. Therefore, this study aims to evaluate the effects of technological rehabilitation utilizing a robotic platform (Hunova® Movendo Technology srl, Genova, IT):

• (i) in terms of improvement in static, dynamic balance, and ambulation (assessed with clinical scales and instrumental measures);
• (ii) on fatigue, on cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference and on quality of life.

Full description

Twenty-four patients of both sexes will be recruited, evaluated, and treated at the Rehabilitation and Physical Medicine Clinic, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome from Febraury 2022 to January 2023. Patients will be divided into two groups by randomization (described below): one group (experimental group, GH) will perform specific rehabilitation for the balance disorder using the robotic platform Hunova® Movendo Technology srl, Genova, IT) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment conventional treatment and one group will perform only the conventional treatment (conventional group, GC), as per daily routine, as described later.

Enrollment: 24 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 55;
• Patients with outcomes of ischemic or hemorrhagic stroke documented through techniques of neuroimaging (magnetic resonance imaging or computed tomography);
• Latency from the acute event between 1 and 6 months;
• Cognitive abilities to execute simple orders and understand directions of the physical therapist [assessed by Token Test (score ≥ 26.5)];
• Ability to walk independently or with little assistance;
• Ability to understand and sign informed consent.

Exclusion criteria

• Presence of systemic, neurological, or cardiac pathologies that make ambulation risky or cause motor deficits;
• Orthopedic or postural problems;
• Presence of plantar ulcers;
• Partial or total amputation of foot segments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Technological Group

Experimental group

Description:

Technological group (TG) patients will undergo robotic treatment for the improvement balance through the robotic platform (Hunova® Movendo Technology srl, Genova, IT), 3 times per week for 45 minutes each, in addition to the conventional treatment (total 180 minutes per day). In particular, the technological rehabilitation performed employing a footboard will be mostly aimed at improving the balance both in sitting and standing position, and will be proposed static and dynamic exercises, exercises dual-task exercises, and exercises to improve trunk control.

Treatment:

Device: Technological Rehabilitation

Control Group

No Intervention group

Description:

Congrol Group (CG) patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive neuromuscular facilitation, etc.).