Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Study Overview
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Brief Summary
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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.

Official Title
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Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study

Conditions
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Multiple Sclerosis, Stroke, Parkinson Disease

Intervention / Treatment
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* Device: Virtual Reality Treadmill Training
* Device: Treadmill training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treadmill Training<br>40' treadmill training walking holding the handrail | Device: Treadmill training<br>* Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.<br>|
| Experimental: Virtual Reality Treadmill Training<br>40' treadmill training walking with virtual visual and auditory cues | Device: Virtual Reality Treadmill Training<br>* Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.<br>* Other names: C-mill treadmill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Modified Dynamic Gait Index | Tool used to assess dynamic balance | Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks | 
| Change in the 6 minutes walking test | tool used to assess walking endurance | Change from Baseline 6 minutes walking test scores at 3-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activity Balance Confidence | Tool used to assess of balance confidence in daily life activities | Change from Baseline Activity Balance Confidence scores at 3-5 weeks | 
| Change in 10-meter walking test | Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task) | Change from Baseline10-meter walking test scores at 3-5 weeks | 
| Change in Trial Making test | 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 from Baseline Trial Making test scores at 3-5 weeks | 
| Change in Raven's Matrices | Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence. | Change from Baseline Raven's Matrices scores at 3-5 weeks |