CClinicalTrials.gg
Status unknownNCT03201692Updated Jul 27, 2017

Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

An interventional study of Virtual Reality Treadmill Training and Treadmill training in Multiple Sclerosis, Stroke and Parkinson Disease, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown at 1 site in Italy. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-07-27.

Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
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Study 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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Conditions studied

  • Multiple Sclerosis
  • Stroke
  • Parkinson Disease
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 48 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Treadmill Training

    40' treadmill training walking holding the handrail

    Device: Treadmill training

  • Experimental
    Virtual Reality Treadmill Training

    40' treadmill training walking with virtual visual and auditory cues

    Device: Virtual Reality Treadmill Training

Interventions

  • DeviceVirtual Reality Treadmill Training

    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

  • DeviceTreadmill training

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

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

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Study locations

1 of 1 sites recruiting
  • Don Gnocchi Foundation
    Milan, 20148, Italy
    • ELISA GERVASONI, MSc · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03201692
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Responsible party
Davide Cattaneo (Research Coordinator, LaRiCE Lab, PhD, Fondazione Don Carlo Gnocchi Onlus) — Principal investigator
First posted
Jun 28, 2017
Start date
Jul 1, 2017
Primary completion
Apr 10, 2019 (estimated)
Completion
Apr 10, 2019 (estimated)
Last update
Jul 27, 2017

Study contacts

Paolo MOcarelli, MD
Contact
pmocarelli@dongnocchi.it
+390210308 ext. 405
Davide Cattaneo, PhD
Contact
dcattaneo@dongnocchi.it
+390240308 ext. 814

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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