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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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8 February 2016 |
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Main ID: |
NCT02419768 |
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Date of registration:
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14/04/2015 |
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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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Effects of Exercise on Long-Range Autocorrelations in Parkinson's Disease
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Scientific title:
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Locomotion of Parkinsonian Patient: Are There Relations Between the Long Range Autocorrelations and the Neurological Impairments, Walking Abilities and the Practice of Physical Exercise? |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02419768 |
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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: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Thierry Lejeune, Professor |
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Address:
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Telephone:
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+32 2 764 16 48 |
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Email:
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thierry.lejeune@uclouvain.be |
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Affiliation:
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Name:
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Thibault B. Warlop, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Université Catholique de Louvain |
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Name:
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Thierry Lejeune, Professor |
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Address:
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Telephone:
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+32 2 764 16 48 |
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Email:
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thierry.lejeune@uclouvain.be |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis idiopathic Parkinson according to the Brain Bank criteria of the United
Kingdom Parkinson's Disease Society
- Disease severity according to modified Hoehn & Yahr stages I to IV
- Absence of dementia Minimal Mini Mental State Examination score of 24 or higher
- Stable drug usage in the last 4 weeks
- Adequate vision and hearing, achieved using corrective lenses and/or hearing aid if
required
Exclusion Criteria:
- Severe co-morbidity, other neurological problems, acute medical problems (e.g. MI,
diabetes) and joint problems affecting mobility
- Unpredictable "Off"-periods (score >2, MDS-UPDRS item 4.5)
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Other: Physical Exercise
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Primary Outcome(s)
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Balance Evaluation Systems Test (BESTest)
[Time Frame: Change from baseline in balance measures at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Secondary Outcome(s)
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Instrumented gait analysis
[Time Frame: Change from baseline in gait parameters (kinematic, kinetic, electromyographic and energetic) at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Impact on Participation and Autonomy Questionnaire (IPAQ)
[Time Frame: Change from baseline in participation and quality of life at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)
[Time Frame: Change from baseline in MDS-UPDRS at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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10 Meter Walk Test (10-MWT)
[Time Frame: Change from baseline in walking speed, step lenght and cadence at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Long-range autocorrelations
[Time Frame: Change from baseline in long-range autocorrelations at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Six Minute Walk Distance (6-MWD)
[Time Frame: Change from baseline in exercise tolerance at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Activities-specific Balance Confidence Scale (ABC-Scale)
[Time Frame: Change from baseline in subjective balance measures (fear of falling) at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)]
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Secondary ID(s)
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IONS - Warlop - 01
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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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