Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05983809
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-08-01
Brief Title:
Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis Effects on Functional Motor and Cognitive Outcomes ROAR-MS
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROAR-MS
Brief Summary:
Multiple sclerosis MS is a chronic inflammatory and neurodegenerative disease of the central nervous system that often results in motor andor 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 on dynamic balance and walking assessed with clinical and instrumental scales
2 on fatigue and cognitive performance in terms of sustained attention dual-task cost and cognitive-motor interference
3 on quality of life
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 on dynamic balance and walking assessed with clinical and instrumental scales
2 on fatigue and cognitive performance in terms of sustained attention dual-task cost and cognitive-motor interference
3 on quality of life
Detailed Description:
Twenty-four patients of both sexes will be recruited evaluated and treated at the Multiple Sclerosis UOS of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome from the date of approval of the study by the ethics committee and for the following 12 months meeting the inclusion criteria Patients will be divided into two groups by randomisation one group experimental group HO Hunova-Observation will perform specific rehabilitation for balance disorder using the robotic platform Hunova Movendo Technology srl Genova IT followed by 4 weeks of observation The other group OH Observation-Hunova will instead carry out 4 weeks of observation at the end of which they will carry out the specific treatment for the balance disorder using the robotic platform Hunova Movendo Technology srl Genova IT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None