Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Stroke Clinical Trial

Official title:

Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201692
• Other study ID #: NCT02960984UL_SM
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: July 25, 2017
• Start date: July 1, 2017
• Est. completion date: April 10, 2019

Study information

• Verified date: July 2017
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Paolo MOcarelli, MD
• Phone: +390210308
• Email: pmocarelli[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Stroke

Intervention

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

Locations

Country	Name	City	State
Italy	Don Gnocchi Foundation	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Activity Balance Confidence	Tool used to assess of balance confidence in daily life activities	Change from Baseline Activity Balance Confidence scores at 3-5 weeks
Secondary	Change in 10-meter walking test	Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task)	Change from Baseline10-meter walking test scores at 3-5 weeks
Secondary	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.	Change from Baseline Trial Making test scores at 3-5 weeks
Secondary	Change in Raven's Matrices	Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence.	Change from Baseline Raven's Matrices scores at 3-5 weeks