Trial Outcomes & Findings for Gait Re-education Program in Subjects With Parkinson´s Disease (NCT NCT05131880)
NCT ID: NCT05131880
Last Updated: 2025-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Before the intervention, up to 15 minutes; and at the end of 12 weeks intervention, up to 15 minutes.
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gait Re-education Program in Subjects With Parkinson´s Disease
Baseline characteristics by cohort
| Measure |
Experimental
n=25 Participants
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.
|
Control
n=27 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
71.32 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
71.37 years
STANDARD_DEVIATION 7.70 • n=7 Participants
|
71.35 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Physical Performance: The Short Physical Performance Battery (SPPB)
|
9.60 units on a scale
STANDARD_DEVIATION 2.47 • n=5 Participants
|
8.78 units on a scale
STANDARD_DEVIATION 2.75 • n=7 Participants
|
9.17 units on a scale
STANDARD_DEVIATION 2.60 • n=5 Participants
|
|
Risk of Falls: FallSkip
|
25.4 units on a scale
STANDARD_DEVIATION 13.91 • n=5 Participants
|
26.48 units on a scale
STANDARD_DEVIATION 18.39 • n=7 Participants
|
25.96 units on a scale
STANDARD_DEVIATION 16.08 • n=5 Participants
|
|
Functionality and independence: Barthel Index
|
91.8 units on a scale
STANDARD_DEVIATION 14.13 • n=5 Participants
|
87.59 units on a scale
STANDARD_DEVIATION 12.12 • n=7 Participants
|
89.62 units on a scale
STANDARD_DEVIATION 13.04 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Comparator: Control Group
n=27 Participants
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.
|
Experimental Group
n=25 Participants
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.
|
|---|---|---|
|
Physical Performance: The Short Physical Performance Battery (SPPB)
Pre intervention
|
8.78 units on a scale
Standard Deviation 2.75
|
9.60 units on a scale
Standard Deviation 2.47
|
|
Physical Performance: The Short Physical Performance Battery (SPPB)
Post intervention
|
8.89 units on a scale
Standard Deviation 2.86
|
10.72 units on a scale
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Comparator: Control Group
n=27 Participants
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.
|
Experimental Group
n=25 Participants
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.
|
|---|---|---|
|
Walk Speed: Timed Up and Go (TUG) Test
Post intervention
|
0.53 Seconds
Standard Deviation 0.19
|
0.67 Seconds
Standard Deviation 0.13
|
|
Walk Speed: Timed Up and Go (TUG) Test
Pre intervention
|
0.55 Seconds
Standard Deviation 0.16
|
0.59 Seconds
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Comparator: Control Group
n=27 Participants
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.
|
Experimental Group
n=25 Participants
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.
|
|---|---|---|
|
Risk of Falls: FallSkip
Pre intervention
|
26.48 units on a scale
Standard Deviation 18.39
|
25.4 units on a scale
Standard Deviation 13.91
|
|
Risk of Falls: FallSkip
Post intervention
|
26.85 units on a scale
Standard Deviation 16.18
|
21.40 units on a scale
Standard Deviation 16.24
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Comparator: Control Group
n=27 Participants
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.
|
Experimental Group
n=25 Participants
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.
|
|---|---|---|
|
Functionality and Independence: Barthel Index
|
87.59 units on a scale
Standard Deviation 12.12
|
91.8 units on a scale
Standard Deviation 14.13
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Comparator: Control Group
n=27 Participants
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.
|
Experimental Group
n=25 Participants
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.
|
|---|---|---|
|
General Satisfaction
|
4.3 units on a scale
Standard Deviation 0.43
|
4.5 units on a scale
Standard Deviation 0.5
|
Adverse Events
Active Comparator: Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place