Parkinson DiseaseStepuPNCT07058285
Steps Against the Burden of Parkinson's Disease - RCT Kiel
A study testing Speed-dependent treadmill training (SDTT) and SDTT+ anteroposterior perturbations in people with Parkinson Disease and Fall, run by University of Kiel at 1 site in Germany.
Trial summary
Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Fall
- What is being tested?
- Speed-dependent treadmill training (SDTT) and SDTT+ anteroposterior perturbations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of PD according to the MDS Criteria
- Hoehn and Yahr stages I to III;
- Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more
- Signed informed consent to participation
Who cannot join
- Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise.
- Moderate or severe depression (BDI-II ≥18)
- Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment.
- Linguistic comprehension capacity less than 75% in ordinary conversation
- Severe psychiatric comorbidity which may interfere with compliance to the study protocol
- History of or current status of substance dependency
Show all 10Show fewer
- Unable to walk less than 1 floor
- Thoracic pain in the last 4 weeks
- Currently enrolled in other interventional studies
- Implanted Deep Brain Stimulation device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jaap van Dieen contact
Germany1 site, 1 recruiting
- Recruiting
University of Kiel
Kiel, 24105
Julius Welzel, +49 431 500 23895, j.welzel@neurologie.uni-kiel.de
About this study
Official title: Steps Against the Burden of Parkinson's Disease
Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life.
This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis.
Read more
In this trials, PD patients will undergo treadmill training with and without adaptations (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a Follow-up 12±2 weeks following T1 with pre/post assessments and a Follow-up 12±2 weeks following T1 at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence.
Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.
Read the detailed description
- Rationale The rationale of this trial is that speed dependent treadmill training (SDTT) improves gait through improved sensorimotor integration, with changes in cortical activity as neural correlates. Additional benefits of treadmill training can be seen if perturbation or adaptations are added. This is based on the idea, that in addition to the sensorimotor integration the reactive balance in trained as well18. Furthermore, it hypothesizes that treadmill training and its effects on gait quality will improve gait self-efficacy, which mediates and/or modifies transfer of training effects to improved daily-life gait. ii. Objectives
Thus, the objectives of our StepuP project are:
- To understand the kinematic and neural mechanisms that underlie improvements in gait due to treadmill training with and without mechanically and VR-triggered gait adaptations in people with PD;
- To assess to what extent improvements in gait due to treadmill training, as measured in the lab, transfer to improvements in daily life mobility;
- To understand the mechanisms that underpin transfer from improvements in gait to improvements of mobility in daily life in people with PD;
- To understand for whom treadmill training improves lab-based gait characteristics and for whom it does not, and understand for whom treadmill training improves mobility in daily life and for whom it does not.
Attaining these objectives will provide a better understanding of the successes and failures of treadmill training to improve gait stability and prevent falls in people with PD at an individual level, which in the medium term will allow targeted delivery of such interventions and in the long term will allow personalization of such interventions to improve outcomes for all.
iii. Endpoints Concerning the endpoints, this trial examines the effect of treadmill training with and without perturbations on gait performance, and neural correlates in people with PD. The primary endpoint is (change in) gait speed, secondary endpoints are divided into three groups (clinical, kinematic and neurophysiological). Clinical measures are used to assess the effect of training on disease symptoms. Kinematic measures are changes from baseline to Follow-up 12±2 weeks following T1, all under controlled conditions (treadmill), and provide insight into gait performance and quality. Neurophysiological measures aim to understand the neural control mechanisms underlying the training effects. On an exploratory level, the study aims to assess the training effects on daily-life gait by using wearable devices and assess gait self-efficacy using previously validated questionnaires.
- Conditions
- Parkinson Disease, Fall
- Being tested
- Speed-dependent treadmill training (SDTT), SDTT+ anteroposterior perturbations
- Keywords
- EEG, EMG, perturbation, daily-life gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed-dependent treadmill training (SDTT)Other
This training methodology focuses on adjusting the treadmill's speed according to the individual's walking pace, creating a more dynamic and adaptive exercise environment. SDTT is designed to mimic real-world walking conditions and challenges, promoting neuromuscular coordination, balance, and overall mobility. By tailoring the treadmill speed to match the user's gait, SDTT encourages the development of natural and efficient walking patterns. This training technique has shown promise in various clinical settings, aiding individuals with gait impairments caused by neurological conditions, musculoskeletal disorders, or post-injury rehabilitation. Its adaptability allows for progressive adjustments as a person's walking abilities improve, making it a versatile tool for optimizing gait mechanics and functional mobility. o ensure continued progress and integration into daily life, home-based walking training, supported by a phone application, will be included between T1 and T2.
SDTT+ anteroposterior perturbationsOther
The SDTT+ anteroposterior perturbations program will trigger reactive gait adaptations by accelerations and decelerations of one of the belts of a split-belt treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Kiel | Experimental | In Kiel, the experimental group will engage in 12-sessions of SDTT with additional anteroposterior perturbations, contrasting with the control group undergoing regular SDTT. Receives: Other: SDTT+ anteroposterior perturbations |
| Control | Active comparator | Not described Receives: Other: Speed-dependent treadmill training (SDTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed - T0
Comfortable walking speed overground
Measured: Baseline
Gait speed - T1
Comfortable walking speed overground
Measured: After Intervention (2-12 weeks)
Gait speed - T2
Comfortable walking speed overground
Measured: After Follow-up 12±2 weeks following T1 (20-32 weeks)
Secondary outcomes (77)
Fall events (occurrence and frequency) and fall related injuries - T0
The number of falls and whether the falls were injurious will be recorded. Twelve-month retrospective.
Measured: Baseline (T0)
Fracture history - T0
Number and type of fracture sustained will be recorded. Twelve-month retrospective.
Measured: Baseline (T0)
Medication - T0
Current medication will be recorded at each visit.
Measured: Baseline (T0)
Medication - T1
Current medication will be recorded at each visit.
Measured: After Intervention (2-12 weeks)
Medication - T2
Current medication will be recorded at each visit.
Measured: Follow-up 12±2 weeks following T1
Euro-Quality of life (EQ-5D) - T0
The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Measured: Baseline (T0)
Euro-Quality of life (EQ-5D) - T1
The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Measured: After Intervention (2-12 weeks)
Euro-Quality of life (EQ-5D) - T2
The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Measured: Follow-up 12±2 weeks following T1
Frailty Index (FI) - T0
Measures frailty based on five criteria: shrinking, low physical endurance/energy, low physical activity, weakness, and slow walking speed.
Measured: Baseline (T0)
Frailty Index (FI) - T1
Measures frailty based on five criteria: shrinking, low physical endurance/energy, low physical activity, weakness, and slow walking speed. For the Frailty Index, higher scores mean a worse outcome (increased frailty).
Measured: After Intervention (2-12 weeks)
Frailty Index (FI) - T2
Measures frailty based on five criteria: shrinking, low physical endurance/energy, low physical activity, weakness, and slow walking speed. For the Frailty Index, higher scores mean a worse outcome (increased frailty).
Measured: Follow-up 12±2 weeks following T1
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T0
Measures fatigue during usual daily activities over the past week. The FACIT-F scale consists of 13 items, each scored from 0 (Not at all) to 4 (Very much). Some items are reverse-scored. The total score ranges from 0 to 52. For the FACIT-F scale, higher scores indicate less fatigue (a better outcome).
Measured: Baseline (T0)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T1
Measures fatigue during usual daily activities over the past week. The FACIT-F scale consists of 13 items, each scored from 0 (Not at all) to 4 (Very much). Some items are reverse-scored. The total score ranges from 0 to 52. For the FACIT-F scale, higher scores indicate less fatigue (a better outcome).
Measured: After Intervention (2-12 weeks)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T2
Measures fatigue during usual daily activities over the past week. The FACIT-F scale consists of 13 items, each scored from 0 (Not at all) to 4 (Very much). Some items are reverse-scored. The total score ranges from 0 to 52. For the FACIT-F scale, higher scores indicate less fatigue (a better outcome).
Measured: Follow-up 12±2 weeks following T1
Kinematics: 3D motion capture data - T0
3D motion capture data.
Measured: Baseline
Kinematics: 3D motion capture data - T1
3D motion capture data.
Measured: After Intervention (2-12 weeks)
Kinematics: 3D motion capture data - T2
3D motion capture data.
Measured: Follow-up 12±2 weeks following T1
Electroencephalography (EEG) - T0
EEG measures brain activity to assess cortical involvement and sensorimotor integration for foot placement control. We'll specifically analyze beta power and beta band corticomuscular coherence with the rectus femoris muscle. Before analysis, EEG data will be cleaned using filtering and ICA to remove artifacts like muscle and eye movements. Coherence will be computed across the gait cycle using time-normalized EEG and EMG cross-spectra, and beamforming will localize sources.
Measured: Baseline
Electroencephalography (EEG) - T1
EEG measures brain activity to assess cortical involvement and sensorimotor integration for foot placement control. We'll specifically analyze beta power and beta band corticomuscular coherence with the rectus femoris muscle. Before analysis, EEG data will be cleaned using filtering and ICA to remove artifacts like muscle and eye movements. Coherence will be computed across the gait cycle using time-normalized EEG and EMG cross-spectra, and beamforming will localize sources.
Measured: After Intervention (2-12 weeks)
Electroencephalography (EEG) - T2
EEG measures brain activity to assess cortical involvement and sensorimotor integration for foot placement control. We'll specifically analyze beta power and beta band corticomuscular coherence with the rectus femoris muscle. Before analysis, EEG data will be cleaned using filtering and ICA to remove artifacts like muscle and eye movements. Coherence will be computed across the gait cycle using time-normalized EEG and EMG cross-spectra, and beamforming will localize sources.
Measured: Follow-up 12±2 weeks following T1
Electromyography (EMG) - T0
Surface EMG records electrical activity of superficial muscles to assess muscle function, fatigue, and activation patterns.
Measured: Baseline
Electromyography (EMG) - T1
Surface EMG records electrical activity of superficial muscles to assess muscle function, fatigue, and activation patterns.
Measured: After Intervention (2-12 weeks)
Electromyography (EMG) - T2
Surface EMG records electrical activity of superficial muscles to assess muscle function, fatigue, and activation patterns.
Measured: Follow-up 12±2 weeks following T1
Gait speed (Preferred and maximal) - T0
Preferred gait speed and maximal gait speed using a 20-m walk test will be derived.
Measured: Baseline
Gait speed (Preferred and maximal) - T1
Preferred gait speed and maximal gait speed using a 20-m walk test will be derived.
Measured: After Intervention (2-12 weeks)
Gait speed (Preferred and maximal) - T2
Preferred gait speed and maximal gait speed using a 20-m walk test will be derived.
Measured: Follow-up 12±2 weeks following T1
Use of mobility aids - T0
The use of commonly used walking aids (indoor and outdoor) will be recorded.
Measured: Baseline
Use of mobility aids - T2
The use of commonly used walking aids (indoor and outdoor) will be recorded.
Measured: Follow-up 12±2 weeks following T1
Timed Up and Go (TUG) - T0
A common clinical measure to assess mobility, balance, and walking ability in older adults.
Measured: Baseline
Timed Up and Go (TUG) - T1
A common clinical measure to assess mobility, balance, and walking ability in older adults.
Measured: After Intervention (2-12 weeks)
Timed Up and Go (TUG) - T2
A common clinical measure to assess mobility, balance, and walking ability in older adults.
Measured: Follow-up 12±2 weeks following T1
Two-minute walking test (2MWT) - T0
Measures functional exercise capacity. Distance in meters covered in 6 minutes is recorded.
Measured: Baseline
Two-minute walking test (2MWT) - T1
Measures functional exercise capacity. Distance in meters covered in 6 minutes is recorded.
Measured: After Intervention (2-12 weeks)
Two-minute walking test (2MWT) - T2
Measures functional exercise capacity. Distance in meters covered in 6 minutes is recorded.
Measured: Follow-up 12±2 weeks following T1
Mini-BESTest - T0
The Mini-BESTest (Mini-Balance Evaluation Systems Test) is a clinical balance assessment tool designed to evaluate various balance control systems. It assesses an individual's balance and stability on a series of functional tasks. The unabbreviated scale title is Mini-Balance Evaluation Systems Test (Mini-BESTest). It has a minimum value of 0 and a maximum value of 28. The Mini-BESTest is comprised of 14 items, each scored on a 3-point ordinal scale (0 = severe impairment, 1 = moderate impairment, 2 = no impairment). The scores from all items are summed to provide a total score. Higher scores on the Mini-BESTest indicate better balance and stability, representing a better outcome.
Measured: Baseline
Mini-BESTest - T1
The Mini-BESTest (Mini-Balance Evaluation Systems Test) is a clinical balance assessment tool designed to evaluate various balance control systems. It assesses an individual's balance and stability on a series of functional tasks. The unabbreviated scale title is Mini-Balance Evaluation Systems Test (Mini-BESTest). It has a minimum value of 0 and a maximum value of 28. The Mini-BESTest is comprised of 14 items, each scored on a 3-point ordinal scale (0 = severe impairment, 1 = moderate impairment, 2 = no impairment). The scores from all items are summed to provide a total score. Higher scores on the Mini-BESTest indicate better balance and stability, representing a better outcome.
Measured: After Intervention (2-12 weeks)
Mini-BESTest - T2
The Mini-BESTest (Mini-Balance Evaluation Systems Test) is a clinical balance assessment tool designed to evaluate various balance control systems. It assesses an individual's balance and stability on a series of functional tasks. The unabbreviated scale title is Mini-Balance Evaluation Systems Test (Mini-BESTest). It has a minimum value of 0 and a maximum value of 28. The Mini-BESTest is comprised of 14 items, each scored on a 3-point ordinal scale (0 = severe impairment, 1 = moderate impairment, 2 = no impairment). The scores from all items are summed to provide a total score. Higher scores on the Mini-BESTest indicate better balance and stability, representing a better outcome.
Measured: Follow-up 12±2 weeks following T1
Modified Gait Efficacy Scale (mGES) - T0
The Modified Gait Efficacy Scale (mGES) assesses an individual's confidence in their walking ability across various challenging everyday circumstances. It is a self-report measure. The unabbreviated scale title is Modified Gait Efficacy Scale (mGES). It has a minimum value of 0 and a maximum value of 100. The mGES typically consists of several items where individuals rate their confidence on a scale (e.g., 0-10 or 0-100) for various walking situations. The total score is often calculated as an average or sum and then converted to a percentage. Higher scores on the Modified Gait Efficacy Scale indicate greater walking confidence, representing a better outcome.
Measured: Baseline
Modified Gait Efficacy Scale (mGES) - T1
The Modified Gait Efficacy Scale (mGES) assesses an individual's confidence in their walking ability across various challenging everyday circumstances. It is a self-report measure. The unabbreviated scale title is Modified Gait Efficacy Scale (mGES). It has a minimum value of 0 and a maximum value of 100. The mGES typically consists of several items where individuals rate their confidence on a scale (e.g., 0-10 or 0-100) for various walking situations. The total score is often calculated as an average or sum and then converted to a percentage. Higher scores on the Modified Gait Efficacy Scale indicate greater walking confidence, representing a better outcome.
Measured: After Intervention (2-12 weeks)
Modified Gait Efficacy Scale (mGES) - T2
The Modified Gait Efficacy Scale (mGES) assesses an individual's confidence in their walking ability across various challenging everyday circumstances. It is a self-report measure. The unabbreviated scale title is Modified Gait Efficacy Scale (mGES). It has a minimum value of 0 and a maximum value of 100. The mGES typically consists of several items where individuals rate their confidence on a scale (e.g., 0-10 or 0-100) for various walking situations. The total score is often calculated as an average or sum and then converted to a percentage. Higher scores on the Modified Gait Efficacy Scale indicate greater walking confidence, representing a better outcome.
Measured: Follow-up 12±2 weeks following T1
Hand grip strength - T0
Hand grip strength.
Measured: Baseline
Short Falls Efficacy Scale International (Short FES-i) - T0
The Short Falls Efficacy Scale International (Short FES-I) measures the level of concern about falling during social and physical activities, both inside and outside the home. It is a widely used self-report questionnaire. It has a minimum value of 7 and a maximum value of 28. The Short FES-I consists of 7 items. Each item is rated on a 4-point scale, from 1 (not concerned at all) to 4 (completely concerned). The scores for all 7 items are summed. Higher scores on the Short FES-I indicate a greater concern about falling, representing a worse outcome.
Measured: Baseline
Short Falls Efficacy Scale International (Short FES-i) - T1
The Short Falls Efficacy Scale International (Short FES-I) measures the level of concern about falling during social and physical activities, both inside and outside the home. It is a widely used self-report questionnaire. It has a minimum value of 7 and a maximum value of 28. The Short FES-I consists of 7 items. Each item is rated on a 4-point scale, from 1 (not concerned at all) to 4 (completely concerned). The scores for all 7 items are summed. Higher scores on the Short FES-I indicate a greater concern about falling, representing a worse outcome.
Measured: After Intervention (2-12 weeks)
Short Falls Efficacy Scale International (Short FES-i) - T2
The Short Falls Efficacy Scale International (Short FES-I) measures the level of concern about falling during social and physical activities, both inside and outside the home. It is a widely used self-report questionnaire. It has a minimum value of 7 and a maximum value of 28. The Short FES-I consists of 7 items. Each item is rated on a 4-point scale, from 1 (not concerned at all) to 4 (completely concerned). The scores for all 7 items are summed. Higher scores on the Short FES-I indicate a greater concern about falling, representing a worse outcome.
Measured: Follow-up 12±2 weeks following T1
Montreal Cognitive Assessment (MoCA) - T0
The Montreal Cognitive Assessment (MoCA) is a quick screening tool designed to detect mild cognitive impairment, assessing a broad range of cognitive domains. It has a minimum value of 0 and a maximum value of 30. The MoCA assesses attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Each correct response contributes to the total score. A score of 26 or above is generally considered normal. Higher scores on the MoCA indicate better cognitive function, representing a better outcome.
Measured: Baseline
Montreal Cognitive Assessment (MoCA) - T2
The Montreal Cognitive Assessment (MoCA) is a quick screening tool designed to detect mild cognitive impairment, assessing a broad range of cognitive domains. It has a minimum value of 0 and a maximum value of 30. The MoCA assesses attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Each correct response contributes to the total score. A score of 26 or above is generally considered normal. Higher scores on the MoCA indicate better cognitive function, representing a better outcome.
Measured: Follow-up 12±2 weeks following T1
Color Trail Test (CTT) - T0
The Color Trail Test (CTT) is a neuropsychological assessment with two parts (CTT-1, CTT-2) that evaluates cognitive flexibility, visual scanning, and executive function. Participants connect numbered circles, then alternate between numbers and letters.
Key measures are completion time (min 0s, max typically 120-240s) and errors. Lower times and fewer errors indicate better attention, mental flexibility, and processing speed, signifying a better outcome.
Measured: Baseline
Color Trail Test (CTT) - T2
The Color Trail Test (CTT) is a neuropsychological assessment with two parts (CTT-1, CTT-2) that evaluates cognitive flexibility, visual scanning, and executive function. Participants connect numbered circles, then alternate between numbers and letters.
Key measures are completion time (min 0s, max typically 120-240s) and errors. Lower times and fewer errors indicate better attention, mental flexibility, and processing speed, signifying a better outcome.
Measured: Follow-up 12±2 weeks following T1
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T0
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive, clinician-rated scale used to assess the severity and progression of Parkinson's Disease. Part III specifically focuses on the Motor Examination. It has a minimum value of 0 and a maximum value of 132 (sum of all 33 items in Part III, each scored 0-4). Part III consists of 33 items (e.g., speech, facial expression, rigidity, tremor, bradykinesia, gait, postural stability), each scored from 0 (normal) to 4 (severe impairment). The scores for all items are summed. Higher scores on the MDS-UPDRS Part III indicate greater motor impairment and more severe Parkinson's disease symptoms, representing a worse outcome.
Measured: Baseline
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T1
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive, clinician-rated scale used to assess the severity and progression of Parkinson's Disease. Part III specifically focuses on the Motor Examination. It has a minimum value of 0 and a maximum value of 132 (sum of all 33 items in Part III, each scored 0-4). Part III consists of 33 items (e.g., speech, facial expression, rigidity, tremor, bradykinesia, gait, postural stability), each scored from 0 (normal) to 4 (severe impairment). The scores for all items are summed. Higher scores on the MDS-UPDRS Part III indicate greater motor impairment and more severe Parkinson's disease symptoms, representing a worse outcome.
Measured: After Intervention (2-12 weeks)
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T2
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive, clinician-rated scale used to assess the severity and progression of Parkinson's Disease. Part III specifically focuses on the Motor Examination. It has a minimum value of 0 and a maximum value of 132 (sum of all 33 items in Part III, each scored 0-4). Part III consists of 33 items (e.g., speech, facial expression, rigidity, tremor, bradykinesia, gait, postural stability), each scored from 0 (normal) to 4 (severe impairment). The scores for all items are summed. Higher scores on the MDS-UPDRS Part III indicate greater motor impairment and more severe Parkinson's disease symptoms, representing a worse outcome.
Measured: Follow-up 12±2 weeks following T1
New Freezing of Gait Questionnaire (NFOGQ) - T0
The New Freezing of Gait Questionnaire (NFOGQ) is a patient-reported outcome measure specifically designed to detect and evaluate the impact and severity of freezing of gait (FOG) in individuals with Parkinson's disease or other neurological conditions. It has a minimum value of 0 and a maximum value of 45. The NFOGQ consists of 9 items, with a total score calculated by summing the scores for all items. Each item is typically scored on a 5-point Likert scale. Higher scores on the NFOGQ indicate a greater severity, frequency, and impact of freezing of gait, representing a worse outcome.
Measured: Baseline
New Freezing of Gait Questionnaire (NFOGQ) - T1
The New Freezing of Gait Questionnaire (NFOGQ) is a patient-reported outcome measure specifically designed to detect and evaluate the impact and severity of freezing of gait (FOG) in individuals with Parkinson's disease or other neurological conditions. It has a minimum value of 0 and a maximum value of 45. The NFOGQ consists of 9 items, with a total score calculated by summing the scores for all items. Each item is typically scored on a 5-point Likert scale. Higher scores on the NFOGQ indicate a greater severity, frequency, and impact of freezing of gait, representing a worse outcome.
Measured: After Intervention (2-12 weeks)
New Freezing of Gait Questionnaire (NFOGQ) - T2
The New Freezing of Gait Questionnaire (NFOGQ) is a patient-reported outcome measure specifically designed to detect and evaluate the impact and severity of freezing of gait (FOG) in individuals with Parkinson's disease or other neurological conditions. It has a minimum value of 0 and a maximum value of 45. The NFOGQ consists of 9 items, with a total score calculated by summing the scores for all items. Each item is typically scored on a 5-point Likert scale. Higher scores on the NFOGQ indicate a greater severity, frequency, and impact of freezing of gait, representing a worse outcome.
Measured: Follow-up 12±2 weeks following T1
Home assessment: Steps per day - T0
The steps per day will be recorded.
Measured: Baseline (T0)
Home assessment: Steps per day - T1
The steps per day will be recorded.
Measured: After Intervention (2-12 weeks)
Home assessment: Steps per day - T2
The steps per day will be recorded.
Measured: Follow-up 12±2 weeks following T1
Home assessment: Amount and length of uninterrupted walk durations - T0
The amount and length of uninterrupted walk durations will be determined.
Measured: Baseline (T0)
Home assessment: Amount and length of uninterrupted walk durations - T1
The amount and length of uninterrupted walk durations will be determined.
Measured: After Intervention (2-12 weeks)
Home assessment: Amount and length of uninterrupted walk durations - T2
The amount and length of uninterrupted walk durations will be determined.
Measured: Follow-up 12±2 weeks following T1
Home assessment: Stride time variability - T0
The stride time variability will be derived.
Measured: Baseline (T0)
Home assessment: Stride time variability - T1
The stride time variability will be derived.
Measured: After Intervention (2-12 weeks)
Home assessment: Stride time variability - T2
The stride time variability will be derived.
Measured: Follow-up 12±2 weeks following T1
Home assessment: Symmetry of gait - T0
Symmetry of gait will be determined.
Measured: Baseline (T0)
Home assessment: Symmetry of gait - T1
Symmetry of gait will be determined.
Measured: After Intervention (2-12 weeks)
Home assessment: Symmetry of gait - T2
Symmetry of gait will be determined.
Measured: Follow-up 12±2 weeks following T1
Home assessment: FOG episodes, Medication, and Physical activity (self-reports) - T0
FOG episodes, Medication and Physical activity will be recorded by self-reports.
Measured: Baseline (T0)
Home assessment: FOG episodes, Medication, and Physical activity (self-reports) - T1
FOG episodes, Medication and Physical activity will be recorded by self-reports.
Measured: After Intervention (2-12 weeks)
Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T0
Weekly Calendars will be used to assess Physical activity, Falls and Injurious Falls.
Measured: Baseline (T0)
Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T1
Weekly Calendars will be used to assess Physical activity, Falls and Injurious Falls.
Measured: After Intervention (2-12 weeks)
Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T2
Weekly Calendars will be used to assess Physical activity, Falls and Injurious Falls.
Measured: Follow-up 12±2 weeks following T1
Acceptability and satisfaction with the intervention (System Usability Scale and PACES) - T1
The Physical Activity Enjoyment Scale (PACES) is a self-report questionnaire designed to measure an individual's enjoyment of physical activity. It typically consists of 18 items where participants rate their feelings about physical activity on a 7-point bipolar scale. It has a minimum possible score of 18 (if each item is rated '1') and a maximum possible score of 126 (if each item is rated '7'). Scores from all 18 items are summed to create a total score. Higher scores on the PACES indicate greater enjoyment of physical activity, representing a better outcome. Additionally it includes questions developed specifically for the components of this study.
Measured: After Intervention (2-12 weeks)
Acceptability and satisfaction with the intervention (System Usability Scale and PACES) - T2
The Physical Activity Enjoyment Scale (PACES) is a self-report questionnaire designed to measure an individual's enjoyment of physical activity. It typically consists of 18 items where participants rate their feelings about physical activity on a 7-point bipolar scale. It has a minimum possible score of 18 (if each item is rated '1') and a maximum possible score of 126 (if each item is rated '7'). Scores from all 18 items are summed to create a total score. Higher scores on the PACES indicate greater enjoyment of physical activity, representing a better outcome. Additionally it includes questions developed specifically for the components of this study.
Measured: Follow-up 12±2 weeks following T1
Changes in attitudes towards physical activity (Exercise Self-Efficacy Scale) - T1
The Exercise Self-Efficacy Scale (ESES) is designed to assess an individual's confidence in their ability to engage in regular exercise, particularly in challenging situations. There are various versions of self-efficacy scales, but they generally follow a similar structure. It has a minimum possible score of 0 (or the lowest point on the chosen confidence scale) and a maximum possible score of 100 (or the highest point on the chosen confidence scale). Participants typically rate their confidence for various exercise-related scenarios on a percentage scale, for instance, 0% = not at all confident to 100% = completely confident. The scores are then averaged or summed. Higher scores on the Exercise Self-Efficacy Scale indicate greater confidence in one's ability to exercise, representing a better outcome.
Measured: After Intervention (2-12 weeks)
Changes in attitudes towards physical activity (Exercise Self-Efficacy Scale) - T2
The Exercise Self-Efficacy Scale (ESES) is designed to assess an individual's confidence in their ability to engage in regular exercise, particularly in challenging situations. There are various versions of self-efficacy scales, but they generally follow a similar structure. It has a minimum possible score of 0 (or the lowest point on the chosen confidence scale) and a maximum possible score of 100 (or the highest point on the chosen confidence scale). Participants typically rate their confidence for various exercise-related scenarios on a percentage scale, for instance, 0% = not at all confident to 100% = completely confident. The scores are then averaged or summed. Higher scores on the Exercise Self-Efficacy Scale indicate greater confidence in one's ability to exercise, representing a better outcome.
Measured: Follow-up 12±2 weeks following T1
Exit interviews (Barriers and enablers to long-term use) - T1
Exit interviews will be conducted to explore the barriers and enablers to long-term use and reasons for ceased involvement (if applicable) using pre-prepared, open-ended questions according to qualitative interview methods.
Measured: After Intervention (2-12 weeks)
Exit interviews (Barriers and enablers to long-term use) - T2
Exit interviews will be conducted to explore the barriers and enablers to long-term use and reasons for ceased involvement (if applicable) using pre-prepared, open-ended questions according to qualitative interview methods.
Measured: Follow-up 12±2 weeks following T1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start25 Jul 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Maetzler, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058285
- Sponsor's protocol ID
- 6ef2e427b002
- Acronym
- StepuP
- Status last verified
- Jun 2025
- First submitted
- 26 Mar 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To ensure high standards of data curation, the widely accepted Brain Imaging Data Structure (BIDS) standard to store the motion, EMG and EEG data will be followed and data will be made public in a coded, de-identified manner.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps Against the Burden of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07058285
- Acronym / sponsor ID
- StepuP / 6ef2e427b002
- Conditions
- Parkinson Disease, Fall
- Keywords
- EEG, EMG, perturbation, daily-life gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life.
This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis.
In this trials, PD patients will undergo treadmill training with and without adaptations (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a Follow-up 12±2 weeks following T1 with pre/post assessments and a Follow-up 12±2 weeks following T1 at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence.
Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.
Detailed description
- Rationale The rationale of this trial is that speed dependent treadmill training (SDTT) improves gait through improved sensorimotor integration, with changes in cortical activity as neural correlates. Additional benefits of treadmill training can be seen if perturbation or adaptations are added. This is based on the idea, that in addition to the sensorimotor integration the reactive balance in trained as well18. Furthermore, it hypothesizes that treadmill training and its effects on gait quality will improve gait self-efficacy, which mediates and/or modifies transfer of training effects to improved daily-life gait. ii. Objectives
Thus, the objectives of our StepuP project are:
- To understand the kinematic and neural mechanisms that underlie improvements in gait due to treadmill training with and without mechanically and VR-triggered gait adaptations in people with PD;
- To assess to what extent improvements in gait due to treadmill training, as measured in the lab, transfer to improvements in daily life mobility;
- To understand the mechanisms that underpin transfer from improvements in gait to improvements of mobility in daily life in people with PD;
- To understand for whom treadmill training improves lab-based gait characteristics and for whom it does not, and understand for whom treadmill training improves mobility in daily life and for whom it does not.
Attaining these objectives will provide a better understanding of the successes and failures of treadmill training to improve gait stability and prevent falls in people with PD at an individual level, which in the medium term will allow targeted delivery of such interventions and in the long term will allow personalization of such interventions to improve outcomes for all.
iii. Endpoints Concerning the endpoints, this trial examines the effect of treadmill training with and without perturbations on gait performance, and neural correlates in people with PD. The primary endpoint is (change in) gait speed, secondary endpoints are divided into three groups (clinical, kinematic and neurophysiological). Clinical measures are used to assess the effect of training on disease symptoms. Kinematic measures are changes from baseline to Follow-up 12±2 weeks following T1, all under controlled conditions (treadmill), and provide insight into gait performance and quality. Neurophysiological measures aim to understand the neural control mechanisms underlying the training effects. On an exploratory level, the study aims to assess the training effects on daily-life gait by using wearable devices and assess gait self-efficacy using previously validated questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiel | Experimental | Other: SDTT+ anteroposterior perturbationsIn Kiel, the experimental group will engage in 12-sessions of SDTT with additional anteroposterior perturbations, contrasting with the control group undergoing regular SDTT. |
| Control | Active comparator | Other: Speed-dependent treadmill training (SDTT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PD according to the MDS Criteria
- Hoehn and Yahr stages I to III;
- Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more
- Signed informed consent to participation
Key exclusion criteria (10 listed)
- Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise.
- Moderate or severe depression (BDI-II ≥18)
- Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment.
- Linguistic comprehension capacity less than 75% in ordinary conversation
- Severe psychiatric comorbidity which may interfere with compliance to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speed-dependent treadmill training (SDTT)This training methodology focuses on adjusting the treadmill's speed according to the individual's walking pace, creating a more dynamic and adaptive exercise environment. SDTT is designed to mimic real-world walking conditions and challenges, promoting neuromuscular coordination, balance, and overall mobility. By tailoring the treadmill speed to match the user's gait, SDTT encourages the development of natural and efficient walking patterns. This training technique has shown promise in various clinical settings, aiding individuals with gait impairments caused by neurological conditions, musculoskeletal disorders, or post-injury rehabilitation. Its adaptability allows for progressive adjustments as a person's walking abilities improve, making it a versatile tool for optimizing gait mechanics and functional mobility. o ensure continued progress and integration into daily life, home-based walking training, supported by a phone application, will be included between T1 and T2. | Other | Control |
| SDTT+ anteroposterior perturbationsThe SDTT+ anteroposterior perturbations program will trigger reactive gait adaptations by accelerations and decelerations of one of the belts of a split-belt treadmill. | Other | Kiel |
Primary outcome
Gait speed - T0
Time frame: Baseline
Comfortable walking speed overground
Gait speed - T1
Time frame: After Intervention (2-12 weeks)
Comfortable walking speed overground
Gait speed - T2
Time frame: After Follow-up 12±2 weeks following T1 (20-32 weeks)
Comfortable walking speed overground
77 secondary outcomes
Fall events (occurrence and frequency) and fall related injuries - T0
Time frame: Baseline (T0)
Fracture history - T0
Time frame: Baseline (T0)
Medication - T0
Time frame: Baseline (T0)
Medication - T1
Time frame: After Intervention (2-12 weeks)
Medication - T2
Time frame: Follow-up 12±2 weeks following T1
Euro-Quality of life (EQ-5D) - T0
Time frame: Baseline (T0)
Euro-Quality of life (EQ-5D) - T1
Time frame: After Intervention (2-12 weeks)
Euro-Quality of life (EQ-5D) - T2
Time frame: Follow-up 12±2 weeks following T1
Frailty Index (FI) - T0
Time frame: Baseline (T0)
Frailty Index (FI) - T1
Time frame: After Intervention (2-12 weeks)
Frailty Index (FI) - T2
Time frame: Follow-up 12±2 weeks following T1
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T0
Time frame: Baseline (T0)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T1
Time frame: After Intervention (2-12 weeks)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T2
Time frame: Follow-up 12±2 weeks following T1
Kinematics: 3D motion capture data - T0
Time frame: Baseline
Kinematics: 3D motion capture data - T1
Time frame: After Intervention (2-12 weeks)
Kinematics: 3D motion capture data - T2
Time frame: Follow-up 12±2 weeks following T1
Electroencephalography (EEG) - T0
Time frame: Baseline
Electroencephalography (EEG) - T1
Time frame: After Intervention (2-12 weeks)
Electroencephalography (EEG) - T2
Time frame: Follow-up 12±2 weeks following T1
Electromyography (EMG) - T0
Time frame: Baseline
Electromyography (EMG) - T1
Time frame: After Intervention (2-12 weeks)
Electromyography (EMG) - T2
Time frame: Follow-up 12±2 weeks following T1
Gait speed (Preferred and maximal) - T0
Time frame: Baseline
Gait speed (Preferred and maximal) - T1
Time frame: After Intervention (2-12 weeks)
Gait speed (Preferred and maximal) - T2
Time frame: Follow-up 12±2 weeks following T1
Use of mobility aids - T0
Time frame: Baseline
Use of mobility aids - T2
Time frame: Follow-up 12±2 weeks following T1
Timed Up and Go (TUG) - T0
Time frame: Baseline
Timed Up and Go (TUG) - T1
Time frame: After Intervention (2-12 weeks)
Timed Up and Go (TUG) - T2
Time frame: Follow-up 12±2 weeks following T1
Two-minute walking test (2MWT) - T0
Time frame: Baseline
Two-minute walking test (2MWT) - T1
Time frame: After Intervention (2-12 weeks)
Two-minute walking test (2MWT) - T2
Time frame: Follow-up 12±2 weeks following T1
Mini-BESTest - T0
Time frame: Baseline
Mini-BESTest - T1
Time frame: After Intervention (2-12 weeks)
Mini-BESTest - T2
Time frame: Follow-up 12±2 weeks following T1
Modified Gait Efficacy Scale (mGES) - T0
Time frame: Baseline
Modified Gait Efficacy Scale (mGES) - T1
Time frame: After Intervention (2-12 weeks)
Modified Gait Efficacy Scale (mGES) - T2
Time frame: Follow-up 12±2 weeks following T1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Yes. To ensure high standards of data curation, the widely accepted Brain Imaging Data Structure (BIDS) standard to store the motion, EMG and EEG data will be followed and data will be made public in a coded, de-identified manner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaap van Dieen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed-dependent treadmill training (SDTT) and SDTT+ anteroposterior perturbations in people with Parkinson Disease and Fall, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter Maetzler (0049 431 500-23981, w.maetzler@neurologie.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed - T0 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.