Clinical trial NCT03021408: Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PD
Gait Dysfunction, Neurologic
Rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effectiveness of three different approaches for the rehabilitation of gait in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: 6-minute walking test (6MWT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Average length of right and left steps
timeFrame: 4 weeks
measure: Coefficient of variance
timeFrame: 4 weeks
measure: Step cycle
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: "Moriggia-Pelascini" Hospital
state: Como
Study officials:
affiliation: "Moriggia-Pelascini" Hospital
name: Frazzitta Giuseppe, MD
role: STUDY_DIRECTOR
References: