ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease (Tr-T-VR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03021408
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
PD Gait Dysfunction, Neurologic Rehabilitation Other: MIRT + Treadmill Other: MIRT + Treadmill Plus Other: MIRT + Virtual Reality Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2017
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 6-minute walking test (6MWT) [ Time Frame: 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 :
  1. Average length of right and left steps [ Time Frame: 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).

  2. Coefficient of variance [ Time Frame: 4 weeks ]
    coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).

  3. Step cycle [ Time Frame: 4 weeks ]
    Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021408


Contacts
Contact: Davide Ferrazzoli, MD +393318643163 davideferrazzoli@gmail.com
Contact: Ilaria Zivi, MD +39034492111 ilaria.zivi@gmail.com

Locations
Italy
"Moriggia-Pelascini" Hospital Recruiting
Gravedona ed Uniti, Como, Italy, 22015
Contact: Davide Ferrazzoli, MD    +393318643163    davideferrazzoli@gmail.com   
Contact: Ilaria Zivi, MD    +393805468322      
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
Investigators
Study Director: Frazzitta Giuseppe, MD "Moriggia-Pelascini" Hospital

Responsible Party: Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT03021408     History of Changes
Other Study ID Numbers: OGZonaMP-PD Gait Rehab
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Parkinson Disease
Neurologic Manifestations
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms