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

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

Study Overview

• Status: Unknown
• Conditions: Rehabilitation; PD; Gait Dysfunction, Neurologic
• Intervention / Treatment: Other: MIRT + Treadmill; Other: MIRT + Treadmill Plus; Other: MIRT + Virtual Reality

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como
    • Gravedona ed Uniti, Como, Italy, 22015
      • Recruiting
      • "Moriggia-Pelascini" Hospital
      • Contact: Davide Ferrazzoli, MD; Phone Number: +393318643163; Email: davideferrazzoli@gmail.com
      • Contact: Ilaria Zivi, MD; Phone Number: +393805468322

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIRT + Treadmill; In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.	Other: MIRT + Treadmill; 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.
Experimental: 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.	Other: MIRT + Treadmill Plus; 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.
Experimental: 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).	Other: MIRT + Virtual Reality; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
• Investigators: Study Director: Frazzitta Giuseppe, MD, "Moriggia-Pelascini" Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: January 7, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Gait Disorders, Neurologic; Neurologic Manifestations
• Other Study ID Numbers: OGZonaMP-PD Gait Rehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No