Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.

NCT05983809 | Recruiting

• 1 other identifier: 0000051/23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic, inflammatory and neurodegenerative disease of the central nervous system that often results in motor and/or cognitive impairment. Epidemiologically, the onset occurs between the ages of 20 and 40, with a peak around the age of 30. MS is an extremely heterogeneous disease in terms of signs and symptoms, both in terms of the neurological systems involved and the degree of impairment and severity. The most common symptoms include, among others, difficulty walking and lack of balance. The lack of stability and coordination reduces independence and mobility, predisposing people with MS to accidental falls and compromising mobility in daily life. Another symptom that characterises MS is cognitive impairment, which mainly alters information processing speed and short- and long-term memory. MS-related cognitive impairment is detectable at every stage of the disease. Very often, people with MS have co-existing cognitive and motor deficits, which add to the complexity of managing MS. In order to address this condition, a treatment strategy that combines cognitive and motor rehabilitation needs to be identified. Despite the increasing availability of effective drug therapies that may impact on balance, rehabilitation is a very important means to counteract the progression of disability and improve physical function, affecting social participation and improving quality of life. In recent years, rehabilitation makes use of various robotic devices, which are based on repeatable, intense and motivating exercises, integrated with an enriched virtual environment, capable of improving the quality of movement. In light of the literature, which mainly focuses on robotic therapy for walking, this pilot study aims to evaluate the effects of a specific robotic treatment for balance in MS patients. The primary objective of the study is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) on static balance. The secondary objective is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT)

1. 1.on dynamic balance and walking (assessed with clinical and instrumental scales)
2. 2.on fatigue and cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference;
3. 3.on quality of life.

Conditions

Multiple Sclerosis; Balance; Cognitive Impairment

Keywords

Rehabilitation; Multiple Sclerosis; Technology; Balance; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  The Berg Balance Scale (BBS) is used to objectively determine a patient's ability(or inability) to safely balance during a series of predetermined tasks. It is a 14item list with each item consisting of a five-point ordinal scale ranging from 0 to 4,with 0 indicating the lowest level of function and 4 the highest level of function andtakes approximately 20 minutes to complete. It does not include the assessmentof gait.

  Change from Baseline BBS at 4 and 8 weeks

Secondary Outcomes (15)

• Modified Fatigue Impact Scale (MFIS)

  Change from Baseline MFIS at 4 and 8 weeks

• Fatigue Scale for Motor and Cognitive Function (FSMC)

  Change from Baseline FSMC at 4 and 8 weeks

• Timed Up and Go test (TUG)

  Change from Baseline TUG at 4 and 8 weeks

• Ambulation Index (AI)

  Change from Baseline Ambulation Index at 4 and 8 weeks

• Walking handicap scale (WHS)

  Change from Baseline Walking handicap scale at 4 and 8 weeks

Study Arms (2)

Experimental Group (HO, Hunova-Observation)

EXPERIMENTAL

Patients in the HO group will undergo a specific rehabilitation treatment for balance disorders using the robotic platform Hunova® Movendo Technology srl, Genova, IT), for 4 weeks, 3 times a week for 45 minutes each. In particular, the technological rehabilitation carried out with the platform will have as main objective the improvement of balance, both in sitting and standing position, and static and dynamic exercises, dual-task exercises and exercises to improve trunk control will be proposed. Afterwards, patients will undergo 4 weeks of observation without rehabilitation treatment.

Device: Technological rehabilitation

Control Group (OH, Observation-Hunova)

ACTIVE COMPARATOR

Patients in the OH group will undergo 4 weeks of observation without rehabilitation treatment, followed by specific rehabilitation treatment for balance disorders using the robotic platform Hunova® Movendo Technology srl, Genova, IT), for 4 weeks, 3 times a week for 45 minutes each. In particular, the technological rehabilitation carried out with the platform will have as main objective the improvement of balance, both in sitting and standing position, and static and dynamic exercises, dual-task exercises and exercises to improve trunk control will be proposed.

Device: Technological rehabilitation

Interventions

Technological rehabilitation DEVICE

Specific rehabilitation for balance disorder using the robotic platform

Also known as: Hunova® MovendoTechnology srl

Control Group (OH, Observation-Hunova); Experimental Group (HO, Hunova-Observation)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitive diagnosis of multiple sclerosis according to McDonald criteria;
• Age between 18 and 65 years;
• Pyramidal or cerebellar system with a score ≥ 2 on the EDSS;
• EDSS between 2 and 3;
• Ability to stand without support for 60 seconds;
• Stability of disease-modifying treatment and absence of clinical relapse of the disease for at least 1 year;
• Cognitive ability to execute simple orders and understand the physiotherapist's instructions \[assessed by Token Test (score ≥ 26.5)\];
• Ability to understand and sign informed consent.

You may not qualify if:

• Significant visual impairment, defined by a visual system score ≥ 2 on the EDSS;
• Presence of vestibular disorders unrelated to MS;
• Presence of psychiatric disorders or severe cognitive impairment, i.e. a Mini Mental State Examination (MMSE) score \< 24 (15);
• Presence of cardiovascular and respiratory disorders;
• Inability to provide informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Silvia Giovannini, MD, phD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Giovannini, MD, phD

CONTACT

+390630154382; silvia.giovannini@policlinicogemelli.it

Letizia Castelli, MS

CONTACT

+390630154382; letizia.castelli@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Interventional, randomised, controlled, cross-over pilot study.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: September 15, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)