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

NCT ID: NCT05131880

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-05-01

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

'TAPIZ FISIOR' gait re-education program combined with conventional physiotherapy program.

The experimental group will undergo a physiotherapy program supplemented by the Fisior Mat Method, with three sessions per week over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention, and at follow-up.

Group Type: EXPERIMENTAL

Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease

Intervention Type: OTHER

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.

Conventional physiotherapy program

The control group will participate in a physiotherapy program three sessions per week for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease

Intervention Type: OTHER

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.

Interventions

Gait Re-education Program Using the Fisior® Mat Sequential Training System 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Alberto Bermejo Franco

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alberto Bermejo Franco

Villaviciosa de Odón, Madrid, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CIPI/21/032

Identifier Type: -

Identifier Source: org_study_id