Parkinson Disease
Conditions
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.
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.
Interventions
OTHERGait 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.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Performance: The Short Physical Performance Battery (SPPB) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Satisfaction | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 22 Participants | 43 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Continuous | 71.32 years STANDARD_DEVIATION 8.39 | 71.37 years STANDARD_DEVIATION 7.7 | 71.35 years STANDARD_DEVIATION 7.96 |
| Functionality and independence: Barthel Index | 91.8 units on a scale STANDARD_DEVIATION 14.13 | 87.59 units on a scale STANDARD_DEVIATION 12.12 | 89.62 units on a scale STANDARD_DEVIATION 13.04 |
| Physical Performance: The Short Physical Performance Battery (SPPB) | 9.60 units on a scale STANDARD_DEVIATION 2.47 | 8.78 units on a scale STANDARD_DEVIATION 2.75 | 9.17 units on a scale STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 27 Participants | 52 Participants |
| Region of Enrollment Spain | 25 participants | 27 participants | 52 participants |
| Risk of Falls: FallSkip | 25.4 units on a scale STANDARD_DEVIATION 13.91 | 26.48 units on a scale STANDARD_DEVIATION 18.39 | 25.96 units on a scale STANDARD_DEVIATION 16.08 |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
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.
Time frame: Before the intervention, up to 20 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator: Control Group | Functionality and Independence: Barthel Index | 87.59 units on a scale | Standard Deviation 12.12 |
| Experimental Group | Functionality and Independence: Barthel Index | 91.8 units on a scale | Standard Deviation 14.13 |
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.
Time frame: Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Comparator: Control Group | Physical Performance: The Short Physical Performance Battery (SPPB) | Pre intervention | 8.78 units on a scale | Standard Deviation 2.75 |
| Active Comparator: Control Group | Physical Performance: The Short Physical Performance Battery (SPPB) | Post intervention | 8.89 units on a scale | Standard Deviation 2.86 |
| Experimental Group | Physical Performance: The Short Physical Performance Battery (SPPB) | Post intervention | 10.72 units on a scale | Standard Deviation 2.01 |
| Experimental Group | Physical Performance: The Short Physical Performance Battery (SPPB) | Pre intervention | 9.60 units on a scale | Standard Deviation 2.47 |
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.
Time frame: Before the intervention, up to 10 minutes; and at the end of 12 weeks intervention, up to 10 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Comparator: Control Group | Risk of Falls: FallSkip | Post intervention | 26.85 units on a scale | Standard Deviation 16.18 |
| Active Comparator: Control Group | Risk of Falls: FallSkip | Pre intervention | 26.48 units on a scale | Standard Deviation 18.39 |
| Experimental Group | Risk of Falls: FallSkip | Pre intervention | 25.4 units on a scale | Standard Deviation 13.91 |
| Experimental Group | Risk of Falls: FallSkip | Post intervention | 21.40 units on a scale | Standard Deviation 16.24 |
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.
Time frame: Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Comparator: Control Group | Walk Speed: Timed Up and Go (TUG) Test | Pre intervention | 0.55 Seconds | Standard Deviation 0.16 |
| Active Comparator: Control Group | Walk Speed: Timed Up and Go (TUG) Test | Post intervention | 0.53 Seconds | Standard Deviation 0.19 |
| Experimental Group | Walk Speed: Timed Up and Go (TUG) Test | Pre intervention | 0.59 Seconds | Standard Deviation 0.13 |
| Experimental Group | Walk Speed: Timed Up and Go (TUG) Test | Post intervention | 0.67 Seconds | Standard Deviation 0.13 |
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.
Time frame: At the end of 12 weeks intervention, up to 10 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator: Control Group | General Satisfaction | 4.3 units on a scale | Standard Deviation 0.43 |
| Experimental Group | General Satisfaction | 4.5 units on a scale | Standard Deviation 0.5 |