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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| '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. |
|
| Conventional physiotherapy program | Active Comparator | The control group will participate in a physiotherapy program three sessions per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberto Bermejo Franco | Villaviciosa de Odón | Madrid | 28670 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41555326 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Control Group | Conventional physiotherapy program for Parkinson's disease, designed to address key therapeutic objectives such as improving postural control, increasing gait stability, reducing freezing episodes, enhancing coordination, and minimizing fall risk. The program included gait training to promote step initiation and continuity, balance exercises to improve weight shifting and reactive postural adjustments, stretching to maintain joint mobility and reduce rigidity, and psychomotor activities to enhance proprioception and movement planning. The therapy was conducted by two physiotherapists per center, with sessions lasting 30 minutes, three times per week, over 12 weeks. The pharmacological treatment that participants regularly received was not modified during the intervention to avoid altering the natural progression of the disease. |
| FG001 | Experimental Group | In addition to conventional therapy, the intervention group followed a treatment protocol using the TCS Fisior® sequential square mat, supervised by a trained physiotherapist from each center. This therapy focused on postural control and gait exercises with progressive intensity: low for the first four weeks, moderate until week eight, and high from weeks nine to twelve. Load progression followed a structured protocol, incorporating increased ankle weights, higher repetitions, reduced rest time, and expanded movement directions from anterior to lateral. The effectiveness of this treatment has already shown preliminary evidence in pilot studies conducted on older adults and Parkinson's patients with gait impairments. These additional sessions lasted 30 minutes and were conducted three times per week over the 12-week intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | The experimental group will participate in a physiotherapy program with the addition of the Fisior Tapestry Method physiotherapy program, three sessions per week, for 12 weeks. An initial assessment will be made at the beginning of the study, another one at the end of the intervention, and another one at follow-up. GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes. |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: Control Group | Conventional physiotherapy program for Parkinson's disease, designed to address key therapeutic objectives such as improving postural control, increasing gait stability, reducing freezing episodes, enhancing coordination, and minimizing fall risk. The program included gait training to promote step initiation and continuity, balance exercises to improve weight shifting and reactive postural adjustments, stretching to maintain joint mobility and reduce rigidity, and psychomotor activities to enhance proprioception and movement planning. The therapy was conducted by two physiotherapists per center, with sessions lasting 30 minutes, three times per week, over 12 weeks. The pharmacological treatment that participants regularly received was not modified during the intervention to avoid altering the natural progression of the disease. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Bermejo Franco | Universidad Europea de Madrid | +34912115535 | alberto.bermejo@universidadeuropea.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 31, 2021 | Sep 5, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Before the intervention, up to 20 minutes. |
| At the end of 12 weeks intervention, up to 10 minutes. |
| BG001 | Control | The control group will participate in a physiotherapy program three sessions per week for 12 weeks. GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was recorded according to the classification system established by the National Institutes of Health and the United States Office of Management and Budget. Categories include American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. Participants self-reported their race at baseline. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Experimental Group | In addition to conventional therapy, the intervention group followed a treatment protocol using the TCS Fisior® sequential square mat, supervised by a trained physiotherapist from each center. This therapy focused on postural control and gait exercises with progressive intensity: low for the first four weeks, moderate until week eight, and high from weeks nine to twelve. Load progression followed a structured protocol, incorporating increased ankle weights, higher repetitions, reduced rest time, and expanded movement directions from anterior to lateral. The effectiveness of this treatment has already shown preliminary evidence in pilot studies conducted on older adults and Parkinson's patients with gait impairments. These additional sessions lasted 30 minutes and were conducted three times per week over the 12-week intervention. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Seconds | Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Before the intervention, up to 10 minutes; and at the end of 12 weeks intervention, up to 10 minutes. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Before the intervention, up to 20 minutes. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | At the end of 12 weeks intervention, up to 10 minutes. |
|
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Experimental Group | In addition to conventional therapy, the intervention group followed a treatment protocol using the TCS Fisior® sequential square mat, supervised by a trained physiotherapist from each center. This therapy focused on postural control and gait exercises with progressive intensity: low for the first four weeks, moderate until week eight, and high from weeks nine to twelve. Load progression followed a structured protocol, incorporating increased ankle weights, higher repetitions, reduced rest time, and expanded movement directions from anterior to lateral. The effectiveness of this treatment has already shown preliminary evidence in pilot studies conducted on older adults and Parkinson's patients with gait impairments. These additional sessions lasted 30 minutes and were conducted three times per week over the 12-week intervention. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |