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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
Sponsor:
Information provided by (Responsible Party):
Davide Cattaneo, Fondazione Don Carlo Gnocchi Onlus

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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.

  4. 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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Paolo MOcarelli, MD +390210308 ext 405 pmocarelli@dongnocchi.it
Contact: Davide Cattaneo, PhD +390240308 ext 814 dcattaneo@dongnocchi.it

Locations
Italy
Don Gnocchi Foundation Recruiting
Milan, Italy, 20148
Contact: ELISA GERVASONI, MSc         
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus

Responsible Party: Davide Cattaneo, Research Coordinator, LaRiCE Lab, PhD, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT03201692     History of Changes
Other Study ID Numbers: NCT02960984UL_SM
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Parkinson Disease
Multiple Sclerosis
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases