Multiple SclerosisNCT03201692
Improving Dynamic Balance and Gait Adaptability Using Treadmill Training
A study testing Virtual Reality Treadmill Training and Treadmill training in people with Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Stroke, Parkinson Disease
- What is being tested?
- Virtual Reality Treadmill Training and Treadmill training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Don Gnocchi Foundation
Milan, 20148
ELISA GERVASONI, MSc
About this study
Official title: Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study
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
- Being tested
- Virtual Reality Treadmill Training, Treadmill training
- Medical subject headings
- Multiple Sclerosis, Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Treadmill TrainingDevice
Also called 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 trainingDevice
Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Training | Active comparator | 40' treadmill training walking holding the handrail Receives: Device: Treadmill training |
| Virtual Reality Treadmill Training | Experimental | 40' treadmill training walking with virtual visual and auditory cues Receives: Device: Virtual Reality Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Modified Dynamic Gait Index
Tool used to assess dynamic balance
Measured: 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
Measured: Change from Baseline 6 minutes walking test scores at 3-5 weeks
Secondary outcomes (4)
Change in Activity Balance Confidence
Tool used to assess of balance confidence in daily life activities
Measured: Change from Baseline Activity Balance Confidence scores at 3-5 weeks
Change in 10-meter walking test
Tool used to assess walking speed in 3 different conditions ( normal speed, fastest speed, cognitive dual task)
Measured: Change from Baseline10-meter walking test scores at 3-5 weeks
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.
Measured: Change from Baseline Trial Making test scores at 3-5 weeks
Change in Raven's Matrices
Test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence.
Measured: Change from Baseline Raven's Matrices scores at 3-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jul 2017
- Primary completion10 Apr 2019 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Cattaneo, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201692
- Sponsor's protocol ID
- NCT02960984UL_SM
- Status last verified
- Jul 2017
- First submitted
- 9 Jun 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study
- ClinicalTrials.gov ID
- NCT03201692
- Acronym / sponsor ID
- NCT02960984UL_SM
- Conditions
- Multiple Sclerosis, Stroke, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Apr 2019 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Training | Active comparator | Device: Treadmill training40' treadmill training walking holding the handrail |
| Virtual Reality Treadmill Training | Experimental | Device: Virtual Reality Treadmill Training40' treadmill training walking with virtual visual and auditory cues |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Treadmill TrainingAlso: C-mill treadmillSubjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues. | Device | Virtual Reality Treadmill Training |
| Treadmill trainingSubjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance. | Device | Treadmill Training |
Primary outcome
Change in the Modified Dynamic Gait Index
Time frame: 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
Time frame: Change from Baseline 6 minutes walking test scores at 3-5 weeks
tool used to assess walking endurance
4 secondary outcomes
Change in Activity Balance Confidence
Time frame: Change from Baseline Activity Balance Confidence scores at 3-5 weeks
Change in 10-meter walking test
Time frame: Change from Baseline10-meter walking test scores at 3-5 weeks
Change in Trial Making test
Time frame: Change from Baseline Trial Making test scores at 3-5 weeks
Change in Raven's Matrices
Time frame: Change from Baseline Raven's Matrices scores at 3-5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Treadmill Training and Treadmill training in people with Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo MOcarelli, MD (+390210308 ext. 405, pmocarelli@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Modified Dynamic Gait Index (time frame: Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.