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

Not Applicable

• Conditions: Rehabilitation; PD; Gait Dysfunction, Neurologic
• Interventions: Other: MIRT + Virtual Reality; Other: MIRT + Treadmill; Other: MIRT + Treadmill Plus

• Registration Number: NCT03021408
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-07
• Study First Submitted QC: 2017-01-12
• Last Update Submitted: 2017-01-12
• Study First Posted: 2017-01-13
• Last Update Posted: 2017-01-13
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIRT + Virtual Reality	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).
MIRT + Treadmill	MIRT + Treadmill	In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.
MIRT + Treadmill Plus	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.

Primary Outcome Measures

Name	Time	Method
6-minute walking test (6MWT)	4 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

"Moriggia-Pelascini" Hospital; 🇮🇹 Gravedona ed Uniti, Como, Italy