Gait Re-education Program in Subjects With Parkinson´s Disease

Parkinson Disease Clinical Trial

Official title:

Effectiveness of a Gait Re-education Program on a Sequential Square Treadmill (Tapiz Fisior) in Subjects With Parkison´s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131880
• Other study ID #: CIPI/21/032
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
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.

Locations

Country	Name	City	State
Spain	Alberto Bermejo Franco	Villaviciosa de Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance and Walk	Short Physical Performance Battery test	15 minutes
Primary	Fall Risk on elderly	Timed Up and Go test	15 minutes
Primary	Fall Risk	Fall Skip	10 minutes
Primary	Functionality and independence	Barthel Index	20 minutes
Secondary	General Satisfaction	General satisfaction test	10 minutes