AR Gait Training for Parkinson's Disease
ConditionPD - Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChang Gung University
About this trial
Gait disorders in Parkinson's disease (PD), particularly in complex environments or under stress, present challenges for accurate evaluation and classification, such as in cases of freezing of gait. Traditional clinical and laboratory settings often fail to replicate the complexity needed for precise classification, making effective rehabilitation difficult. This study aims to address these challenges by developing an augmented reality (AR)-based environment that mimics real-world stressors and dynamically adapts to the patient's condition. The AR system is designed to facilitate individualized gait training and rehabilitation by modifying environmental difficulty based on real-time feedback from gait performance and stress levels.
Building on Gentile's taxonomy of tasks, the investigators have incorporated PD-specific factors, such as cognitive dual tasks, into our environment classification system. Preliminary results suggest that this system effectively elicits varying gait and heart rate variability (HRV) responses, indicating different stress levels.
This trial will further test the AR environment's ability to classify patients based on their responses to complex, interactive environments, while also investigating the effects of adaptive AR-based gait training on both gait and stress management in individuals with PD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Musculoskeletal injuries on legs
Osteoporosis.
Any peripheral or central nervous system injury or disease patients.
Trial design
Design model
Parallel
Treatments tested in this trial
AR gait training
Procedure/SurgeryParticipants will walk on a pathway projected in augmented reality (AR), following the instructions provided on the pathway Each session will last for 60 minutes, conducted three times per week, over a period of six weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PD patientsExperimental treatment 1 intervention
Group B: PD patients (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Walking Speed
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Time frame
Baseline, 6 weeks, 8 weeks2
Step Length
The linear distance between the two ankles, typically expressed in centimeter(cm).
Time frame
Baseline, 6 weeks, 8 weeks3
Step Time
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Time frame
Baseline, 6 weeks, 8 weeks4
Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR)
SDRR is the standard deviation of all recorded RR intervals (the time between successive heartbeats) over a specific period, usually expressed in milliseconds. This measure captures the total variability in heart rate, representing the physiological responses to a variety of internal and external stimuli. High SDRR values generally indicate greater heart rate variability, which is associated with good cardiovascular health and resilience to stress.
Time frame
Baseline, 6 weeks, 8 weeksSecondary outcomes
1
Double Support Time
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
Time frame
Baseline, 6 weeks, 8 weeks2
Single Support Time
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle
Time frame
Baseline, 6 weeks, 8 weeks3
Swing Time
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.
Time frame
Baseline, 6 weeks, 8 weeks4
Stance Time
The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds
Time frame
Baseline, 6 weeks, 8 weeksSponsors and contacts
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Source ClinicalTrials.gov