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Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

D

Don Carlo Gnocchi Onlus Foundation

Status

Unknown

Conditions

Stroke
Multiple Sclerosis
Parkinson Disease

Treatments

Device: Virtual Reality Treadmill Training
Device: Treadmill training

Study type

Interventional

Funder types

Other

Identifiers

NCT03201692
NCT02960984UL_SM

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

20 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

Treadmill Training
Active Comparator group
Description:
40' treadmill training walking holding the handrail
Treatment:
Device: Treadmill training
Virtual Reality Treadmill Training
Experimental group
Description:
40' treadmill training walking with virtual visual and auditory cues
Treatment:
Device: Virtual Reality Treadmill Training

Trial contacts and locations

1

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Central trial contact

Davide Cattaneo, PhD; Paolo MOcarelli, MD

Data sourced from clinicaltrials.gov

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