Back to results

Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Primary Purpose

Multiple Sclerosis, Stroke, Parkinson Disease

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Virtual Reality Treadmill Training

Treadmill training

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Don Gnocchi FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treadmill Training

Virtual Reality Treadmill Training

Arm Description

40' treadmill training walking holding the handrail

40' treadmill training walking with virtual visual and auditory cues

Outcomes

Primary Outcome Measures

Change in the Modified Dynamic Gait Index

Tool used to assess dynamic balance

Change in the 6 minutes walking test

tool used to assess walking endurance

Secondary Outcome Measures

Change in Activity Balance Confidence

Tool used to assess of balance confidence in daily life activities

Change in 10-meter walking test

Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task)

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 in Raven's Matrices

Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence.

Full Information

NCT ID

NCT03201692

First Posted

June 9, 2017

Last Updated

July 25, 2017

Sponsor

Fondazione Don Carlo Gnocchi Onlus

1. Study Identification

Unique Protocol Identification Number

NCT03201692

Brief Title

Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

April 10, 2019 (Anticipated)

Study Completion Date

April 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Stroke, Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treadmill Training

Arm Type

Active Comparator

Arm Description

40' treadmill training walking holding the handrail

Arm Title

Virtual Reality Treadmill Training

Arm Type

Experimental

Arm Description

40' treadmill training walking with virtual visual and auditory cues

Intervention Type

Device

Intervention Name(s)

Virtual Reality Treadmill Training

Other Intervention Name(s)

C-mill treadmill

Intervention Description

Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.

Intervention Type

Device

Intervention Name(s)

Treadmill training

Intervention Description

Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.

Primary Outcome Measure Information:

Title

Change in the Modified Dynamic Gait Index

Description

Tool used to assess dynamic balance

Time Frame

Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks

Title

Change in the 6 minutes walking test

Description

tool used to assess walking endurance

Time Frame

Change from Baseline 6 minutes walking test scores at 3-5 weeks

Secondary Outcome Measure Information:

Title

Change in Activity Balance Confidence

Description

Tool used to assess of balance confidence in daily life activities

Time Frame

Change from Baseline Activity Balance Confidence scores at 3-5 weeks

Title

Change in 10-meter walking test

Description

Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task)

Time Frame

Change from Baseline10-meter walking test scores at 3-5 weeks

Title

Change in Trial Making test

Description

Time Frame

Change from Baseline Trial Making test scores at 3-5 weeks

Title

Change in Raven's Matrices

Description

Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence.

Time Frame

Change from Baseline Raven's Matrices scores at 3-5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paolo MOcarelli, MD

Phone

+390210308

Ext

405

pmocarelli@dongnocchi.it

First Name & Middle Initial & Last Name or Official Title & Degree

Davide Cattaneo, PhD

Phone

+390240308

Ext

814

dcattaneo@dongnocchi.it

Facility Information:

Facility Name

Don Gnocchi Foundation

City

Milan

ZIP/Postal Code

20148

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ELISA GERVASONI, MSc

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

We'll reach out to this number within 24 hrs