Clinical trial NCT06196866: Effectiveness of Exergaming in Adittion to Conventional Treatment for Physical Therapy in People with Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Exergaming
Nintendo Wii Fit
Nintendo Ring Fit Adventure
Physical therapy
Randomized controlled trial
Neurological rehabilitation
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

(i) Diagnosis of MS in any of its types (clinically isolated syndrome, relapsing-remitting MS, primary progressive MS or secondary progressive MS) based on the McDonald criteria.

(ii) Age over 18 years.

(iii) Mini-Mental State Examination score \> 19 points.

(iv) Score on the Expanded Disability Status Scale (EDSS) under 7.0 points.

Exclusion Criteria:

(i) Diagnosis of another disease that affects balance and/or coordination.

(ii) Exacerbation or steroid treatment in the 30 days prior to inclusion in the study.

(iii) Presence of visual deficits.

Primary outcomes:
measure: Physical Functional Capacity (6MWT)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).
measure: Quality Of Life (MSQOL-54)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).
measure: Balance (Tinetti Balance Scale)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).
measure: Strength in Lower Limbs (Handheld dynamometer)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).
measure: Spasticity in Lower Limbs (Modified Ashworth Scale)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: University of Cordoba
Study officials:
affiliation: Universidad de Córdoba
name: Amaranta De Miguel Rubio, PhD
role: STUDY_DIRECTOR
affiliation: University of Cadiz
name: David Lucena Anton, PhD
role: STUDY_DIRECTOR
References: