Parkinson DiseaseNCT05131880
Gait Re-education Program in Subjects With Parkinson´s Disease
A study testing Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease in people with Parkinson Disease, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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"… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Medical criteria for contraindication of treatment.
- Severe behavioral problems that hinder participation in the training program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's DiseaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| '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. Receives: 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. Receives: Other: Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the intervention, up to 20 minutes.
Secondary outcomes (1)
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.
Measured: At the end of 12 weeks intervention, up to 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Apr 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Bermejo Franco, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131880
- Sponsor's protocol ID
- CIPI/21/032
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2021
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alegre-Tamariz J, Ramirez C, Runzer-Colmenares FM, Parodi JF, Arrizabalaga-Otaegui A, Bermejo-Franco A. Effects of a gait training program with the Fisior(R) sequential square mat on balance and gait in patients with Parkinson's disease: a randomized clinical trial. BMC Complement Med Ther. 2026 Jan 19;26(1):56. doi: 10.1186/s12906-026-05252-2.
PubMed 41555326
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Gait Re-education Program on a Sequential Square Treadmill (Tapiz Fisior) in Subjects With Parkison´s Disease
- ClinicalTrials.gov ID
- NCT05131880
- Acronym / sponsor ID
- CIPI/21/032
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'TAPIZ FISIOR' gait re-education program combined with conventional physiotherapy program. | Experimental | Other: Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's DiseaseThe 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. |
| Conventional physiotherapy program | Active comparator | Other: Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's DiseaseThe control group will participate in a physiotherapy program three sessions per week for 12 weeks. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Medical criteria for contraindication of treatment.
- Severe behavioral problems that hinder participation in the training program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's DiseaseRandomized 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. | Other | 'TAPIZ FISIOR' gait re-education program combined with conventional physiotherapy program., Conventional physiotherapy program |
Primary outcome
Physical Performance: The Short Physical Performance Battery (SPPB)
Time frame: 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.
Walk Speed: Timed Up and Go (TUG) Test
Time frame: 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.
Risk of Falls: FallSkip
Time frame: 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.
Functionality and Independence: Barthel Index
Time frame: 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.
1 secondary outcome
General Satisfaction
Time frame: At the end of 12 weeks intervention, up to 10 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41555326Alegre-Tamariz J, Ramirez C, Runzer-Colmenares FM, Parodi JF, Arrizabalaga-Otaegui A, Bermejo-Franco A. Effects of a gait training program with the Fisior(R) sequential square mat on balance and gait in patients with Parkinson's disease: a randomized clinical trial. BMC Complement Med Ther. 2026 Jan 19;26(1):56. doi: 10.1186/s12906-026-05252-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Re-education Program Using the Fisior® Mat Sequential Training System in Subjects with Parkinson's Disease in people with Parkinson Disease, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Performance: The Short Physical Performance Battery (SPPB) (time frame: Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.