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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE

• Registration Number: NCT05131880
• Lead Sponsor: Universidad Europea de Madrid

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-20
• Study First Posted: 2021-11-23
• Primary Completion: 2022-04-01
• Study Completion: 2022-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE	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.
Control	GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE	The control group will participate in a physiotherapy program three sessions per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Fall Risk	10 minutes	Fall Skip
Functionality and independence	20 minutes	Barthel Index
Balance and Walk	15 minutes	Short Physical Performance Battery test
Fall Risk on elderly	15 minutes	Timed Up and Go test

Secondary Outcome Measures

Name	Time	Method
General Satisfaction	10 minutes	General satisfaction test

Trial Locations

Locations (1)

Alberto Bermejo Franco; 🇪🇸 Villaviciosa de Odón, Madrid, Spain