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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03021408 |
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Date of registration:
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07/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease
Tr-T-VR |
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Scientific title:
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Evaluation of the Effectiveness of Three Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease: Treadmill Versus Treadmill-plus Versus Virtual Reality |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03021408 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Davide Ferrazzoli, MD |
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Address:
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Telephone:
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+393318643163 |
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Email:
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davideferrazzoli@gmail.com |
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Affiliation:
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Name:
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Frazzitta Giuseppe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Moriggia-Pelascini" Hospital |
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Name:
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Davide Ferrazzoli, MD |
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Address:
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Telephone:
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+393318643163 |
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Email:
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davideferrazzoli@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of "probable" idiopathic Parkinson's disease according to Gelb et al (Gelb,
1999);
- Mild to moderate stage of disease (stage 2-3) according to Hoehn & Yahr scale;
- Ability to walk on treadmill;
- Visual and hearing capacity sufficient to perceive the cues;
- No cognitive impairment (Mini-Mental State Examination score = 26);
- Stable pharmacological treatment since 2 weeks before admission and during
rehabilitation;
Exclusion Criteria:
- Diagnosis of atypical or vascular Parkinsonism;
- Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and
vestibular disorders which could affect patient's locomotion or balance;
- Neuropsychiatric disturbances;
- Severe dyskinesia;
- Severe freezing of gait;
Age minimum:
50 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gait Dysfunction, Neurologic
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PD
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Rehabilitation
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Intervention(s)
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Other: MIRT + Treadmill
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Other: MIRT + Treadmill Plus
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Other: MIRT + Virtual Reality
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Primary Outcome(s)
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6-minute walking test (6MWT)
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Average length of right and left steps
[Time Frame: 4 weeks]
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Step cycle
[Time Frame: 4 weeks]
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Coefficient of variance
[Time Frame: 4 weeks]
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Secondary ID(s)
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OGZonaMP-PD Gait Rehab
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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