Predictors of Gait Improvement in Patients With Parkinson's Disease After Rehabilitation
NCT ID: NCT03336307
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2014-05-31
2017-07-31
Brief Summary
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Besides the shorten-step gait clinical description of the gait disorder in PD, in the last years, studies using modern 3D motion analysis systems have further detailed the gait pattern in PD disclosing abnormalities in cadence, stance duration, swing duration, double support duration, leg length, step length, velocity, hip, knee and ankle ROMs. Such abnormal gait parameters seem to correlate with the clinical outcomes of UPDRS score, H-Y stage and milliequivalents of levodopa taken. Importantly, gait parameters can either normalize or improve after several rehabilitative treatment strategies including physiotherapy, assistive equipment, sensory cueing, treadmill training, physical activity, home base exercises. However, none of the previous studies specifically investigated which biomechanical factor can be modified after rehabilitation and which clinical characteristic can predict the rehabilitation-induced gait improvement. This would be extremely important to typifying, grouping and selecting patients, optimizing the rehabilitative strategies and cost management.
The aims of the present study were to evaluate in a sample of patients with PD: i) which gait parameters can be modified after a short-term rehabilitation program; ii) which, if any, clinical variable can predict the improvement of the gait function after rehabilitation. At this aim we quantitatively evaluated the gait performance of PD patients by means of a 3-D motion analysis system.
Detailed Description
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All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase.
Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
The study complied with the Helsinki Declaration and received local ethics committee approval. Prior to taking part in the study, all the participants gave a written consent after a fully explanation of the experimental procedure.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with Parkinson's disease
All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase.
Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
All patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease
Rehabilitation program
all patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease and focus on:
* endurance, strength, flexibility and balance with functional practice for all H/Y stage
* endurance also for H/Y stage 1,
* motor learning principles and cue functional for H/Y stage 2-3
* external cues and self-instruction strategies and attention H/Y for stage 2-3 The rehabilitative program comprised 60-minute sessions a day (3d/wk).
Interventions
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Rehabilitation program
all patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease and focus on:
* endurance, strength, flexibility and balance with functional practice for all H/Y stage
* endurance also for H/Y stage 1,
* motor learning principles and cue functional for H/Y stage 2-3
* external cues and self-instruction strategies and attention H/Y for stage 2-3 The rehabilitative program comprised 60-minute sessions a day (3d/wk).
Eligibility Criteria
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Inclusion Criteria
* Hoehn and Yahr stages 1 to 3.
* All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks
Exclusion Criteria
* moderate or severe depression (defined as scores of \>17 on the Beck Depression Inventory \[BDI\]), -. orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
48 Years
80 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Mariano Serrao
Clinical Professor
Principal Investigators
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Guido Caramanico, MD
Role: PRINCIPAL_INVESTIGATOR
Università "La Sapienza di Roma"
Locations
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Policlinico Italia Srl
Rome, Lazio, Italy
Countries
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References
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Meunier S, Pol S, Houeto JL, Vidailhet M. Abnormal reciprocal inhibition between antagonist muscles in Parkinson's disease. Brain. 2000 May;123 ( Pt 5):1017-26. doi: 10.1093/brain/123.5.1017.
Pistacchi M, Gioulis M, Sanson F, De Giovannini E, Filippi G, Rossetto F, Zambito Marsala S. Gait analysis and clinical correlations in early Parkinson's disease. Funct Neurol. 2017 Jan/Mar;32(1):28-34. doi: 10.11138/fneur/2017.32.1.028.
Vieregge P, Stolze H, Klein C, Heberlein I. Gait quantitation in Parkinson's disease--locomotor disability and correlation to clinical rating scales. J Neural Transm (Vienna). 1997;104(2-3):237-48. doi: 10.1007/BF01273184.
Pau M, Corona F, Pili R, Casula C, Sors F, Agostini T, Cossu G, Guicciardi M, Murgia M. Effects of Physical Rehabilitation Integrated with Rhythmic Auditory Stimulation on Spatio-Temporal and Kinematic Parameters of Gait in Parkinson's Disease. Front Neurol. 2016 Aug 11;7:126. doi: 10.3389/fneur.2016.00126. eCollection 2016.
Keus SH, Munneke M, Nijkrake MJ, Kwakkel G, Bloem BR. Physical therapy in Parkinson's disease: evolution and future challenges. Mov Disord. 2009 Jan 15;24(1):1-14. doi: 10.1002/mds.22141.
Other Identifiers
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s001
Identifier Type: -
Identifier Source: org_study_id