Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Not Applicable

• Conditions: Multiple Sclerosis; Stroke; Parkinson Disease
• Interventions: Device: Treadmill training; Device: Virtual Reality Treadmill Training

• Registration Number: NCT03201692
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Status Verified: 2017-07
• Study Start: 2017-07-01
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27
• Primary Completion: 2019-04-10
• Study Completion: 2019-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treadmill Training	Treadmill training	40' treadmill training walking holding the handrail
Virtual Reality Treadmill Training	Virtual Reality Treadmill Training	40' treadmill training walking with virtual visual and auditory cues

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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 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.

Trial Locations

Locations (1)

Don Gnocchi Foundation; 🇮🇹 Milan, Italy