Gait Re-education Program in Subjects With Parkinson´s Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Older than 50 years.
- Diagnosed Parkinson Disease.
- Not to be institutionalized.
- Barthel index scores of ≥ 60.
- Ability to communicate and to get up and walk at least 10 m (33 ft)
Exclusion Criteria:
- Medical criteria for contraindication of treatment.
- Severe behavioral problems that hinder participation in the training program.
Sites / Locations
- Alberto Bermejo Franco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
The experimental group will participate in a physiotherapy program with the addition of the Fisior Tapestry Method physiotherapy program, three sessions per week, for 12 weeks. An initial assessment will be made at the beginning of the study, another one at the end of the intervention, and another one at follow-up.
The control group will participate in a physiotherapy program three sessions per week for 12 weeks.
Outcomes
Primary Outcome Measures
Balance and Walk
Short Physical Performance Battery test
Fall Risk on elderly
Timed Up and Go test
Fall Risk
Fall Skip
Functionality and independence
Barthel Index
Secondary Outcome Measures
General Satisfaction
General satisfaction test
Full Information
NCT ID
NCT05131880
First Posted
November 8, 2021
Last Updated
November 14, 2022
Sponsor
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05131880
Brief Title
Gait Re-education Program in Subjects With Parkinson´s Disease
Official Title
Effectiveness of a Gait Re-education Program on a Sequential Square Treadmill (Tapiz Fisior) in Subjects With Parkison´s Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment status.
Detailed Description
All participants interested in participating in the present study will be part of the research project. Once recruited, they will be randomly assigned to two intervention groups: A and B. Group A (control group) will perform a conventional physiotherapy treatment 2/3 sessions per week of 30 minutes duration; on the other hand, group B (intervention group) will perform the treatment of group A and a therapeutic supplement of 2-3 sessions per week of about 30 minutes. During the research period, several measurements of the variables studied will be taken: one before the intervention, one immediately after the end of the intervention, and another measurement 12 weeks after the end of the intervention.
The treatment will be carried out and supervised at all times by qualified physiotherapists, who will explain to you what the treatment consists of, the days you should attend, and the schedules. No adverse effects are expected from this therapy that could pose a risk for health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will participate in a physiotherapy program with the addition of the Fisior Tapestry Method physiotherapy program, three sessions per week, for 12 weeks.
An initial assessment will be made at the beginning of the study, another one at the end of the intervention, and another one at follow-up.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will participate in a physiotherapy program three sessions per week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
Intervention Description
Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment condition.
Primary Outcome Measure Information:
Title
Balance and Walk
Description
Short Physical Performance Battery test
Time Frame
15 minutes
Title
Fall Risk on elderly
Description
Timed Up and Go test
Time Frame
15 minutes
Title
Fall Risk
Description
Fall Skip
Time Frame
10 minutes
Title
Functionality and independence
Description
Barthel Index
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
General Satisfaction
Description
General satisfaction test
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 50 years.
Diagnosed Parkinson Disease.
Not to be institutionalized.
Barthel index scores of ≥ 60.
Ability to communicate and to get up and walk at least 10 m (33 ft)
Exclusion Criteria:
Medical criteria for contraindication of treatment.
Severe behavioral problems that hinder participation in the training program.
Facility Information:
Facility Name
Alberto Bermejo Franco
City
Villaviciosa de Odón
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Gait Re-education Program in Subjects With Parkinson´s Disease
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