Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official 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

Conditions
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PD, Gait Dysfunction, Neurologic, Rehabilitation

Intervention / Treatment
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* Other: MIRT + Treadmill
* Other: MIRT + Treadmill Plus
* Other: MIRT + Virtual Reality


Participation Criteria
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Eligibility 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;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIRT + Treadmill<br>In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues. | Other: MIRT + Treadmill<br>* 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.<br>|
| Experimental: MIRT + Treadmill Plus<br>In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues. | Other: MIRT + Treadmill Plus<br>* 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.<br>|
| Experimental: MIRT + Virtual Reality<br>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). | Other: MIRT + Virtual Reality<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walking test (6MWT) | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average length of right and left steps | 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). | 4 weeks | 
| Coefficient of variance | coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls). | 4 weeks | 
| Step cycle | Step cycle (cycle/s), calculated by averaging the step cycles during the exercise. | 4 weeks |