Back to resultsThe Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
treadmill training with cues
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, treadmill, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
Parkinson Disease
Exclusion Criteria:
comorbidity with other neurological condition
Sites / Locations
- Ospedale Generale di zona Moriggia PelasciniRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treadmill training
Arm Description
20-minutes treadmill training per day, 6 times a week, for 4 weeks
Outcomes
Primary Outcome Measures
Length of step
Secondary Outcome Measures
Full Information
NCT ID
NCT02731599
First Posted
April 3, 2016
Last Updated
April 3, 2017
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT02731599
Brief Title
The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
Official Title
The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.
Detailed Description
Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training with visual and auditory cues is useful in improving the gait's parameters in patients in early-moderate stages of disease. No data are available about the effectiveness of this training in those subjects in advanced stages of PD. The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.
150 patients with PD in early-moderate and advanced stages of disease (50 in H&Y stage 2, group 1, 50 in H&Y stage 3, group 2 and 50 in H&Y stage 4, group 3) were enrolled. All patients underwent an intensive treatment: 20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, treadmill, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treadmill training
Arm Type
Experimental
Arm Description
20-minutes treadmill training per day, 6 times a week, for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
treadmill training with cues
Intervention Description
20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.
Primary Outcome Measure Information:
Title
Length of step
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson Disease
Exclusion Criteria:
comorbidity with other neurological condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Ortelli
Phone
3332974872
Email
ortellipaola73@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Frazzitta
Phone
+393442719916
Email
frazzitta64@gmail.com
Facility Information:
Facility Name
Ospedale Generale di zona Moriggia Pelascini
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
Paola Ortelli, PsyD
Phone
+393332974872
Email
ortellipaola73@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
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