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Clinical Trials/NCT03201692
NCT03201692
Unknown
N/A

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

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country48 target enrollmentJuly 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
48
Locations
1
Primary Endpoint
Change in the Modified Dynamic Gait Index
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
April 10, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Davide Cattaneo

Research Coordinator, LaRiCE Lab, PhD

Fondazione Don Carlo Gnocchi Onlus

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in 10-meter walking test(Change from Baseline10-meter walking test scores at 3-5 weeks)
  • Change in Raven's Matrices(Change from Baseline Raven's Matrices scores at 3-5 weeks)
  • Change in Activity Balance Confidence(Change from Baseline Activity Balance Confidence scores at 3-5 weeks)
  • Change in Trial Making test(Change from Baseline Trial Making test scores at 3-5 weeks)

Study Sites (1)

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