Technological Balance and Gait Rehabilitation in Patients With Stroke Sequelae: Functional, Motor and Cognitive Outcomes

NCT ID: NCT05280587

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2023-01-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke; Gait Disorders, Neurologic; Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Technological Group

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.

Group Type: EXPERIMENTAL

Technological Rehabilitation

Intervention Type: DEVICE

Specific rehabilitation for balance disorder using the robotic platform

Control Group

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.).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Technological Rehabilitation

Specific rehabilitation for balance disorder using the robotic platform

Intervention Type: DEVICE

Other Intervention Names

Hunova® Movendo Technology srl

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

GIOVANNINI SILVIA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Giovannini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , Italy

Countries

Italy

References

Giovannini S, Iacovelli C, Brau F, Loreti C, Fusco A, Caliandro P, Biscotti L, Padua L, Bernabei R, Castelli L. RObotic-Assisted Rehabilitation for balance and gait in Stroke patients (ROAR-S): study protocol for a preliminary randomized controlled trial. Trials. 2022 Oct 12;23(1):872. doi: 10.1186/s13063-022-06812-w.

Reference Type: DERIVED

PMID: 36224575 (View on PubMed)

Other Identifiers

0003731/22

Identifier Type: -

Identifier Source: org_study_id