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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Villaviciosa de Odón, Madrid, Spain, 28670
      • Alberto Bermejo Franco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: '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.	Other: 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.
Active Comparator: Conventional physiotherapy program; The control group will participate in a physiotherapy program three sessions per week for 12 weeks.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Performance: The Short Physical Performance Battery (SPPB)	The Short Physical Performance Battery (SPPB) assesses lower limb function and mobility through three subtests: standing balance (0-4), 4-m gait speed (0-4), and five-times chair rise (0-4). Subtest scores are summed for a total range of 0-12, with higher scores indicating better performance. The SPPB is widely used to detect mobility limitations, frailty, and disability risk, and has been proposed as an indicator of the mobility subdomain of intrinsic capacity.	Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.
Walk Speed: Timed Up and Go (TUG) Test	The Timed Up and Go (TUG) test assesses basic mobility by measuring the time to stand from a chair, walk three meters, turn, return, and sit down. The time reflects walking speed, balance, turning ability, and overall functional mobility. Shorter times indicate better mobility, while longer times suggest slower gait and potential functional limitations.	Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.
Risk of Falls: FallSkip	FallSkip is a validated tool for assessing fall risk using a portable inertial sensor placed on the lumbar spine. It evaluates parameters such as balance, gait, reaction time, and strength during standardized tasks. Results are integrated into a global score ranging from 0 (highest risk) to 100 (lowest risk), with higher scores indicating better performance and reduced fall risk.	Before the intervention, up to 10 minutes; and at the end of 12 weeks intervention, up to 10 minutes.
Functionality and Independence: Barthel Index	The Barthel Index is a validated scale measuring functionality and independence in activities of daily living (ADLs). It assesses 10 domains including feeding, bathing, dressing, mobility, and continence. Scores range from 0 (total dependence) to 100 (complete independence). Higher scores indicate greater functional autonomy, while lower scores reflect higher dependency and care needs.	Before the intervention, up to 20 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Satisfaction	The General Satisfaction test is used to assess participants' overall satisfaction with the intervention. Scores range from 0 to 5, where 0 indicates a very poor experience and 5 indicates an excellent experience. The scale reflects the participant's subjective evaluation of the intervention, including factors such as perceived usefulness, comfort, and outcomes. Higher scores represent greater satisfaction. This scale provides a quick and simple way to capture the overall impression of the intervention from the participant's perspective.	At the end of 12 weeks intervention, up to 10 minutes.

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 20, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: CIPI/21/032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No