Improving Dynamic Balance and Gait Adaptability Using Treadmill Training
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|ClinicalTrials.gov Identifier: NCT03201692|
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : July 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Stroke Parkinson Disease||Device: Virtual Reality Treadmill Training Device: Treadmill training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||April 10, 2019|
|Estimated Study Completion Date :||April 10, 2019|
Active Comparator: Treadmill Training
40' treadmill training walking holding the handrail
Device: Treadmill training
Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.
Experimental: Virtual Reality Treadmill Training
40' treadmill training walking with virtual visual and auditory cues
Device: Virtual Reality Treadmill Training
Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.
Other Name: C-mill treadmill
- Change in the Modified Dynamic Gait Index [ Time Frame: 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 [ Time Frame: Change from Baseline 6 minutes walking test scores at 3-5 weeks ]tool used to assess walking endurance
- Change in Activity Balance Confidence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201692
|Contact: Paolo MOcarelli, MD||+390210308 ext email@example.com|
|Contact: Davide Cattaneo, PhD||+390240308 ext firstname.lastname@example.org|
|Don Gnocchi Foundation||Recruiting|
|Milan, Italy, 20148|
|Contact: ELISA GERVASONI, MSc|