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

Primary Purpose

PD, Gait Dysfunction, Neurologic, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MIRT + Treadmill
MIRT + Treadmill Plus
MIRT + Virtual Reality
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PD

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • "Moriggia-Pelascini" HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MIRT + Treadmill

MIRT + Treadmill Plus

MIRT + Virtual Reality

Arm Description

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

In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2017
Last Updated
January 12, 2017
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT03021408
Brief Title
Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease
Acronym
Tr-T-VR
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PD, Gait Dysfunction, Neurologic, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIRT + Treadmill
Arm Type
Experimental
Arm Description
In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.
Arm Title
MIRT + Treadmill Plus
Arm Type
Experimental
Arm Description
In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.
Arm Title
MIRT + Virtual Reality
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
MIRT + Treadmill
Intervention Description
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
Intervention Name(s)
MIRT + Treadmill Plus
Intervention Description
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
Intervention Name(s)
MIRT + Virtual Reality
Intervention Description
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 Measure Information:
Title
6-minute walking test (6MWT)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Average length of right and left steps
Description
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).
Time Frame
4 weeks
Title
Coefficient of variance
Description
coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).
Time Frame
4 weeks
Title
Step cycle
Description
Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Ferrazzoli, MD
Phone
+393318643163
Email
davideferrazzoli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Zivi, MD
Phone
+39034492111
Email
ilaria.zivi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frazzitta Giuseppe, MD
Organizational Affiliation
"Moriggia-Pelascini" Hospital
Official's Role
Study Director
Facility Information:
Facility Name
"Moriggia-Pelascini" Hospital
City
Gravedona ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Ferrazzoli, MD
Phone
+393318643163
Email
davideferrazzoli@gmail.com
First Name & Middle Initial & Last Name & Degree
Ilaria Zivi, MD
Phone
+393805468322

12. IPD Sharing Statement

Plan to Share IPD
No

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

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