Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

N/AUnknownNCT03201692

Fondazione Don Carlo Gnocchi Onlus48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis Stroke Parkinson Disease

Virtual Reality Treadmill TrainingDEVICE

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

Treadmill trainingDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Tool used to assess dynamic balance

Time frame: 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

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

Secondary Outcomes

Change in Activity Balance Confidence

Tool used to assess of balance confidence in daily life activities

Time frame: 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)

Time frame: 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.

Time frame: 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.

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