NCT05131880

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

Completed NA Results posted Last updated 9 September 2025

What this trial tests

NA trial testing Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease in Parkinson Disease in 52 participants. Completed in 1 May 2024.

Timeline

1 November 2021

Primary endpoint
1 April 2022

1 May 2024

Quick facts

Lead sponsor	Universidad Europea de Madrid
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	52
Start date	1 November 2021
Primary completion	1 April 2022
Estimated completion	1 May 2024
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Universidad Europea de Madrid

Who can join

Adults 50 to 100, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Physical Performance: The Short Physical Performance Battery (SPPB) Primary · Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.

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.

Pre intervention

Group	Value	95% CI
Active Comparator: Control Group	8.78	± 2.75
Experimental Group	9.60	± 2.47

Post intervention

Group	Value	95% CI
Active Comparator: Control Group	8.89	± 2.86
Experimental Group	10.72	± 2.01

Walk Speed: Timed Up and Go (TUG) Test Primary · Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.

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.

Pre intervention

Group	Value	95% CI
Active Comparator: Control Group	0.55	± 0.16
Experimental Group	0.59	± 0.13

Post intervention

Group	Value	95% CI
Active Comparator: Control Group	0.53	± 0.19
Experimental Group	0.67	± 0.13

Risk of Falls: FallSkip Primary · Before the intervention, up to 10 minutes; and at the end of 12 weeks intervention, up to 10 minutes.

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.

Pre intervention

Group	Value	95% CI
Active Comparator: Control Group	26.48	± 18.39
Experimental Group	25.4	± 13.91

Post intervention

Group	Value	95% CI
Active Comparator: Control Group	26.85	± 16.18
Experimental Group	21.40	± 16.24

Functionality and Independence: Barthel Index Primary · Before the intervention, up to 20 minutes.

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.

Group	Value	95% CI
Active Comparator: Control Group	87.59	± 12.12
Experimental Group	91.8	± 14.13

General Satisfaction Secondary · At the end of 12 weeks intervention, up to 10 minutes.

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.

Group	Value	95% CI
Active Comparator: Control Group	4.3	± 0.43
Experimental Group	4.5	± 0.5

Sponsor's own 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 status.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of a gait training program with the Fisior<sup>®</sup> sequential square mat on balance and gait in patients with Parkinson's disease: a randomized clinical trial.
   Alegre-Tamariz J, Ramirez C, Runzer-Colmenares FM, Parodi JF, et al · · 2026 · PMID 41555326 · DOI 10.1186/s12906-026-05252-2