Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Multiple Sclerosis; Parkinson Disease
• Intervention / Treatment: Device: Treadmill training; Device: Virtual Reality Treadmill Training

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davide Cattaneo, PhD; Phone Number: 814 +390240308; Email: dcattaneo@dongnocchi.it
• Study Contact Backup: Name: Paolo MOcarelli, MD; Phone Number: 405 +390210308; Email: pmocarelli@dongnocchi.it

Study Locations

• Italy
  • Milan, Italy, 20148
    • Recruiting
    • Don Gnocchi Foundation
    • Contact: ELISA GERVASONI, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: C-mill treadmill

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): April 10, 2019
• Study Completion (Anticipated): April 10, 2019

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple Sclerosis; Parkinson Disease
• Other Study ID Numbers: NCT02960984UL_SM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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