Multiple Sclerosis, Parkinson Disease, Stroke
Conditions
Brief summary
Balance and gait problems in subjects with neurological disease lead to reduced mobility, loss of independence and frequent falls. Treadmill training is a widely used form of treatment and it has been used in subjects with neurological disease to ameliorate walking and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently introduced to practice gait adaptability elicited by aligning foot placement relative to the projected visual context. Forty-eight subjects with neurological disease will receive treadmill training treatment randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training. The aim of this randomized controlled study is to assess whether Treadmill training with Virtual Reality is better than Traditional Treadmill training in improving dynamic balance and cognitive aspects in subjects with neurological diseases.
Interventions
Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.
DEVICETreadmill training
Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Multiple Sclerosis (no relapse within the previous three months;), Parkinsons Disease (Hoenhn and Yahr Scale ≤4), Stroke (Time from onset \>2 months) * Able to walk 20 meters with or without assistive device * Cognitive impairment (MMSE score ≥ 21)
Exclusion criteria
* Unable to understand the aim of the study and unable to sign the informed consent * Steroidal drugs therapy for subjects with Multiple Sclerosis * Subjects with Psychiatric disorders * Subjects with Visual impairments * Subjects with cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Modified Dynamic Gait Index | Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks | Tool used to assess dynamic balance |
| Change in the 6 minutes walking test | Change from Baseline 6 minutes walking test scores at 3-5 weeks | tool used to assess walking endurance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activity Balance Confidence | Change from Baseline Activity Balance Confidence scores at 3-5 weeks | Tool used to assess of balance confidence in daily life activities |
| Change in 10-meter walking test | Change from Baseline10-meter walking test scores at 3-5 weeks | Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task) |
| Change in Trial Making test | Change from Baseline Trial Making test scores at 3-5 weeks | The Trail Making Test is a neuropsychological tapping visual attention and task switching. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. |
| Change in Raven's Matrices | Change from Baseline Raven's Matrices scores at 3-5 weeks | Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence. |
Countries
Italy
Contacts
Primary ContactPaolo MOcarelli, MD
Backup ContactDavide Cattaneo, PhD
Outcome results
None listed