Clinical trial NCT05280587: Technological Balance and Gait Rehabilitation in Patients With Stroke Sequelae: Functional, Motor and Cognitive Outcomes
Official title: Riabilitazione Tecnologica Dell'Equilibrio e Del Cammino in Pazienti Con Esiti di Ictus: Effetti su Outcome Funzionale, Motorio e Cognitivo (ROAR-S).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Balance
Keywords: Rehabilitation
Technology
Balance
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional pilot randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Motricity Index (MI)
timeFrame: Change from Baseline Motricity Index at 4 weeks
measure: Berg Balance Scale (BBS)
timeFrame: Change from Baseline Berg Balance Scale at 4 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from Baseline Timed Up and Go Test at 4 weeks
measure: Short physical performance battery (SPPB)
timeFrame: Change from Baseline Short physical performance battery at 4 weeks
measure: Ambulation Index (AI)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
measure: Walking handicap scale (WHS)
timeFrame: Change from Baseline Walking handicap scale at 4 weeks
measure: Functional Ambulation Classification (FAC)
timeFrame: Change from Baseline Functional Ambulation Classification at 4 weeks
measure: 10 Meter Walk Test (10mWT)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Six-minute walk test (6MWT)
timeFrame: Change from Baseline Six-minute walk test at 4 weeks
measure: Barthel Modified Index (BMI)
timeFrame: Change from Baseline Barthel Modified Index at 4 weeks
measure: EuroQol- 5 Dimension (EQ-5D)
timeFrame: Change from Baseline EuroQol- 5 Dimension at 4 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline Modified Fatigue Impact Scale at 4 weeks
measure: Fatigue Scale for Motor and Cognitive Function (FSMC)
timeFrame: Change from Baseline Fatigue Scale for Motor and Cognitive Function at 4 weeks
measure: Frontal Assessment Battery (FAB)
timeFrame: Change from Baseline Frontal Assessment Battery at 4 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline Symbol Digit Modalities Test at 4 weeks
measure: Trail Making Test (TMT)
timeFrame: Change from Baseline Trail Making Test at 4 weeks
measure: The Stroop Colour Word Test (SCWT)
timeFrame: Change from Baseline Stroop Colour Word Test at 4 weeks
measure: The Cancellation Test of Digits (CTD)
timeFrame: Change from Baseline Cancellation Test of Digits at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Silvia Giovannini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.