Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

NCT03201692 | Unknown

• 1 other identifier: NCT02960984UL_SM
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Stroke; Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change in the Modified Dynamic Gait Index

  Tool used to assess dynamic balance

  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

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

Secondary Outcomes (4)

• Change in Activity Balance Confidence

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

• Change in 10-meter walking test

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

• Change in Trial Making test

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

• Change in Raven's Matrices

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

Study Arms (2)

Treadmill Training

ACTIVE COMPARATOR

40' treadmill training walking holding the handrail

Device: Treadmill training

Virtual Reality Treadmill Training

EXPERIMENTAL

40' treadmill training walking with virtual visual and auditory cues

Device: Virtual Reality Treadmill Training

Interventions

Virtual Reality Treadmill Training DEVICE

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

Also known as: C-mill treadmill

Virtual Reality Treadmill Training

Treadmill training DEVICE

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

Treadmill Training

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Milan, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Stroke; Parkinson Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Paolo MOcarelli, MD

CONTACT

+390210308; pmocarelli@dongnocchi.it

Davide Cattaneo, PhD

CONTACT

+390240308; dcattaneo@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator, LaRiCE Lab, PhD

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 28, 2017
• Study Start: July 1, 2017
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)