Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 3:07 PM
Study NCT ID:
NCT06196866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2023-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Exergaming in Adittion to Conventional Treatment for Physical Therapy in People with Multiple Sclerosis
Sponsor:
Universidad de Córdoba
Organization:
Study Overview
Official Title:
Effectiveness of Two Different Exergaming Systems in Addition to Conventional Treatment for Physical Therapy in Patients with Multiple Sclerosis: a Study Protocol for a Multicenter, Assessor-blind, 24-week, Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
None
Brief Summary:
The present study aims to evaluate the effectiveness of two different exergaming systems in addition to conventional treatment on physical functional capacity, balance, muscle strength, spasticity in lower limbs and quality of life compared to an isolated conventional intervention in patients with multiple sclerosis. The secondary aim will be to compare the differences between both exergaming groups.
Detailed Description:
Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system, which produces demyelination and axonal damage in the brain and spinal cord. Since there is currently no treatment for this condition, the goal of rehabilitation is to assist people with their manifestations. Over the last decade, exergaming with commercial consoles has demonstrated potential benefits in managing motor and functional impairments. However, new videogame strategies and assessment in randomized controlled trials are necessary to obtain significant results in different outcomes.
The hypothesis is that the exergaming systems in addition to conventional treatment will show statistically significant improvements on motor skills, spasticity, and quality of life results compared to conventional therapy alone. Therefore, this project aims to evaluate the effectiveness of two different exergaming systems in addition to conventional treatment on physical functional capacity, balance, muscle strength, spasticity in lower limbs and quality of life compared to an isolated conventional intervention in patients with multiple sclerosis. The investigators here design a multi-center, assessor-blind, 24-weeks, randomized controlled trial protocol. The achievement of the present project would serve to analyze the benefits of an alternative exercise program in the motor and functional rehabilitation program of multiple sclerosis patients and to identify the subjects in whom the benefits would be greater and whose implementation would have greater priority.
The hypothesis is that the exergaming systems in addition to conventional treatment will show statistically significant improvements on motor skills, spasticity, and quality of life results compared to conventional therapy alone. Therefore, this project aims to evaluate the effectiveness of two different exergaming systems in addition to conventional treatment on physical functional capacity, balance, muscle strength, spasticity in lower limbs and quality of life compared to an isolated conventional intervention in patients with multiple sclerosis. The investigators here design a multi-center, assessor-blind, 24-weeks, randomized controlled trial protocol. The achievement of the present project would serve to analyze the benefits of an alternative exercise program in the motor and functional rehabilitation program of multiple sclerosis patients and to identify the subjects in whom the benefits would be greater and whose implementation would have greater priority.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: