Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

NCT03201692 — Not applicable, Unknown, 48 participants, Fondazione Don Carlo Gnocchi ETS

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

Registry	NCT03201692
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	48 (Estimated)
Sponsor	Fondazione Don Carlo Gnocchi ETS (Other)
Conditions	Multiple Sclerosis, Stroke, Parkinson Disease
Interventions	Virtual Reality Treadmill Training, Treadmill training (Device)
Dates	start 2017-07-01, primary completion 2019-04-10 (estimated), completion 2019-04-10 (estimated), first posted 2017-06-28, last updated 2017-07-27
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Treadmill Training	Active comparator	Device: Treadmill training	40' treadmill training walking holding the handrail
Virtual Reality Treadmill Training	Experimental	Device: Virtual Reality Treadmill Training	40' treadmill training walking with virtual visual and auditory cues

Virtual Reality Treadmill Training (Device), also known as C-mill treadmill: Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.
Treadmill training (Device): Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.

+Outcome measures

Primary outcomes

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 outcomes

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 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 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.
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.

+Eligibility

Sex: All, ages: 20 Years to 85 Years

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

+Locations (1)

Facility	City	Country	Status
Don Gnocchi Foundation	Milan	Italy	Recruiting

My Notes

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