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

NCT05131880 | Completed Results

• 1 other identifier: CIPI/21/032
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• General Satisfaction

  At the end of 12 weeks intervention, up to 10 minutes.

Study Arms (2)

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

EXPERIMENTAL

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

Conventional physiotherapy program

ACTIVE COMPARATOR

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

Interventions

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

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

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Medical criteria for contraindication of treatment.
• Severe behavioral problems that hinder participation in the training program.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Alberto Bermejo Franco

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Alberto Bermejo Franco
• Organization: Universidad Europea de Madrid

alberto.bermejo@universidadeuropea.es

+34912115535

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 23, 2021
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)