Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease (Tr-T-VR)
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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD patients demonstrate reduced stride length and walking speed during free ambulation, while double support duration and cadence rate are increased. Gait disorders are generally poorly responsive to dopaminergic treatments and are related to reduced quality of life and augmented risk of falls. Different rehabilitation techniques based on compensatory and learning strategies, which principally exploit the use of cues to bypass the defective basal ganglia and to ameliorate performance through practice, have been demonstrated to be effective in improving gait in patients with PD. Cueing techniques represent the central core for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that treadmill training can improve gait performance in PD patients. It probably acts as an external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait parameters when compared to treadmill alone. Recently, the application of virtual reality (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the interaction of the person with a virtual environment with the aim to promote motor learning through enhanced perceptions (visual, auditory, and haptic inputs).
It has been widely demonstrated that a multidisciplinary, intensive, goal-based, motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within MIRT.
This study aims at investigating the superiority or the non-inferiority of these different devices in improving gait in PD patients in the context of MIRT.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Como
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Gravedona ed Uniti, Como, Włochy, 22015
- Rekrutacyjny
- "Moriggia-Pelascini" Hospital
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Kontakt:
- Davide Ferrazzoli, MD
- Numer telefonu: +393318643163
- E-mail: davideferrazzoli@gmail.com
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Kontakt:
- Ilaria Zivi, MD
- Numer telefonu: +393805468322
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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;
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: MIRT + Treadmill
In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.
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PD patients will undergo a 4-week MIRT.
All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.
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Eksperymentalny: MIRT + Treadmill Plus
In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.
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PD patients will undergo a 4-week MIRT.
All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.
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Eksperymentalny: MIRT + Virtual Reality
In the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs).
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PD patients will undergo a 4-week MIRT.
All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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6-minute walking test (6MWT)
Ramy czasowe: 4 weeks
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Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium.
Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible.
No encouragement is offered during the test and no cues are used.
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4 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Average length of right and left steps
Ramy czasowe: 4 weeks
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The average length of right and left steps (expressed in centimetres and calculated by averaging the length of all the right steps and left steps, respectively).
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4 weeks
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Coefficient of variance
Ramy czasowe: 4 weeks
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coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).
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4 weeks
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Step cycle
Ramy czasowe: 4 weeks
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Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.
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4 weeks
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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Frazzitta Giuseppe, MD, "Moriggia-Pelascini" Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- OGZonaMP-PD Gait Rehab
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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