Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Unknown status

CT.gov ID

NCT03201692

Collaborator

(none)

Enrollment

Location

Arms

21.3

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Stroke Parkinson Disease	Device: Virtual Reality Treadmill Training Device: Treadmill training	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2017

Anticipated Primary Completion Date :

Apr 10, 2019

Anticipated Study Completion Date :

Apr 10, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in the Modified Dynamic Gait Index [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 [Change from Baseline 6 minutes walking test scores at 3-5 weeks]
tool used to assess walking endurance

Secondary Outcome Measures

Change in Activity Balance Confidence [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Don Gnocchi Foundation	Milan		Italy	20148

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Davide Cattaneo, Research Coordinator, LaRiCE Lab, PhD, Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT03201692

Other Study ID Numbers:

NCT02960984UL_SM

First Posted:

Jun 28, 2017

Last Update Posted:

Jul 27, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Parkinson Disease

Multiple Sclerosis

Study Results

No Results Posted as of Jul 27, 2017