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

NCT ID: NCT03021408

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-05-31

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.

Conditions

PD; Gait Dysfunction, Neurologic; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MIRT + Treadmill

In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.

Group Type: EXPERIMENTAL

MIRT + Treadmill

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

MIRT + Treadmill Plus

Intervention Type: OTHER

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.

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).

Group Type: EXPERIMENTAL

MIRT + Virtual Reality

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frazzitta Giuseppe, MD

Role: STUDY_DIRECTOR

"Moriggia-Pelascini" Hospital

Locations

"Moriggia-Pelascini" Hospital

Gravedona Ed Uniti, Como, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Davide Ferrazzoli, MD

Role: CONTACT

davideferrazzoli@gmail.com

+393318643163

Ilaria Zivi, MD

Role: CONTACT

ilaria.zivi@gmail.com

+39034492111

Facility Contacts

Davide Ferrazzoli, MD

Role: primary

davideferrazzoli@gmail.com

+393318643163

Ilaria Zivi, MD

Role: backup

+393805468322

Other Identifiers

OGZonaMP-PD Gait Rehab

Identifier Type: -

Identifier Source: org_study_id