Trial results for a gait re-education program in Parkinson's Disease were posted on ClinicalTrials.gov on 2025-09-09, involving 52 participants.
Background
Parkinson's Disease is a progressive neurodegenerative disorder characterized by motor symptoms such as tremor, rigidity, bradykinesia, and postural instability, which significantly impact gait and balance. These motor impairments can lead to an increased risk of falls and reduced quality of life. Current management strategies often involve pharmacotherapy to manage symptoms and physical therapy to maintain mobility and function. Interventions focused on gait re-education are crucial for addressing specific movement patterns and improving functional independence in individuals with Parkinson's Disease.
Trial design
This completed study, designated as Phase NA, enrolled 52 participants diagnosed with Parkinson Disease in mild or moderate stages with altered gait patterns. Participants were randomized into two groups: an experimental group receiving a gait re-education program called "TAPIZ FISIOR" – motor control and learning added to a conventional physiotherapy program; and a control group receiving only a conventional physiotherapy program. Evaluators were blinded to the patient's treatment status.
Key results
The trial reported key measurements related to physical performance, walk speed, and risk of falls:
- Physical Performance: The Short Physical Performance Battery (SPPB) (units on a scale):
- For the Active Comparator: Control Group, the mean score was initially 8.78 (Standard Deviation 2.75) and later 8.89 (Standard Deviation 2.86).
- For the Experimental Group, the mean score was initially 9.60 (Standard Deviation 2.47) and later 10.72 (Standard Deviation 2.01).
- Walk Speed: Timed Up and Go (TUG) Test (Seconds):
- For the Active Comparator: Control Group, the mean time was initially 0.55 (Standard Deviation 0.16) and later 0.53 (Standard Deviation 0.19).
- For the Experimental Group, the mean time was initially 0.59 (Standard Deviation 0.13) and later 0.67 (Standard Deviation 0.13).
- Risk of Falls: FallSkip (units on a scale):
- For the Active Comparator: Control Group, the mean score was initially 26.48 (Standard Deviation 18.39) and later 26.85 (Standard Deviation 16.18).
- For the Experimental Group, the mean score was initially 25.4 (Standard Deviation 13.91) and later 21.40 (Standard Deviation 16.24).
What this means
The results suggest that the "TAPIZ FISIOR" gait re-education program, when added to conventional physiotherapy, may improve physical performance and reduce the risk of falls in individuals with Parkinson's Disease. The experimental group showed an increase in Short Physical Performance Battery scores from 9.60 to 10.72 units, indicating improved physical function, compared to a smaller change in the control group. Additionally, the experimental group's FallSkip score decreased from 25.4 to 21.40 units, suggesting a potential reduction in fall risk. However, the Timed Up and Go (TUG) test results showed an increase in mean time for the experimental group from 0.59 to 0.67 seconds, which typically indicates a decrease in walk speed or mobility, while the control group showed a slight decrease in time. These mixed outcomes highlight the complex nature of gait rehabilitation in Parkinson's Disease and warrant further investigation with statistical analyses to determine significance.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05131880, titled "Gait Re-education Program in Subjects With Parkinson´s Disease", were posted on 2025-09-09 on clinicaltrials.gov.