Parkinson DiseaseSBT FOG-TRAINNCT05511597
Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease
A study testing Split-belt treadmill training, Complex task practice and Upper-limb coordination and power in people with Parkinson Disease and Freezing of Gait, run by KU Leuven at 1 site in Belgium.
Trial summary
A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait, Split-belt Treadmill
- What is being tested?
- Split-belt treadmill training, Complex task practice and Upper-limb coordination and power
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Dec 2022to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Be between 40 - 90 years of age
- Have a diagnosis of Parkinson's disease
- Be able to walk for 10 min without an aid
- Be able to follow and understand the oral instructions of the investigator
- Have a disease stage of I to IV (while ON-medication)
- Have had no change in your Parkinson's medication in the past month (or to your deep brain stimulator if applicable) and also no planned changes in medication over the next 4 months
- Have at least about 1 "freezing" episode per day (based on the New Freezing of Gait Questionnaire: N-FOG)
- Not participating in another clinical trial
- Have no acute joint disease
- Not have any other condition that affects your walking pattern or prevents you from completing all study tasks
- Have not undergone major surgery or hospitalization in the last 3 months
- No substance abuse
- No depressive disorder or other apathetic disorder that precludes daily exercise
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Faculty of Movement and Rehabilitation Sciences (FaBeR)
Leuven, 3001
About this study
Official title: Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.
- Conditions
- Parkinson Disease, Freezing of Gait, Split-belt Treadmill
- Being tested
- Split-belt treadmill training, Complex task practice, Upper-limb coordination and power
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-belt treadmill trainingBehavioural
Split-belt walking with various speed ratios between the two legs, applied with random-block practice
Complex task practiceBehavioural
Overground gait flexibility training with added cognitive tasks
Upper-limb coordination and powerBehavioural
Dynamic upper-limb mobility, coordination and power exercises with dual-tasking
| Study group | Role | What they receive |
|---|---|---|
| SBT+CP | Experimental | Split-belt training + complex task practice Receives: Behavioral: Split-belt treadmill training; Behavioral: Complex task practice |
| SBT+PL | Active comparator | Split-belt training + upper-limb exercise Receives: Behavioral: Split-belt treadmill training; Behavioral: Upper-limb coordination and power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Time Frozen during turning in place
Percentage Time Frozen scored from video of rapid alternating full turns in place. Based on earlier work showing immediate effects of SBT training on FOG during this task.
Measured: up to 8 weeks post intervention
Time to complete Timed Up and Go (TUG)
Overall time to complete the Timed Up and Go task. The training is expected to improve multiple transitions between straight walking and turning and should be reflected in the overall task time.
Measured: up to 8 weeks post intervention
Secondary outcomes (2)
Percentage Time Frozen over all FOG-provoking tasks
Percentage Time Frozen scored from videos of Turning in place,TUG, Hotspot door and Hotspot personalized.
Measured: up to 8 weeks post intervention
Percentage Time Frozen over 1-week free-living monitoring
Percentage Time Frozen estimated from FOG-detection algorithm using free-living sensor data captured over 1 week.
Measured: up to 8 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start16 Dec 2022
- Primary completion31 Oct 2025
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised single-blind parallel-group study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Nieuwboer, KU Leuven
- Investigators
- Alice Nieuwboer, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511597
- Sponsor's protocol ID
- S65984
- Acronym
- SBT FOG-TRAIN
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Cruz N, Seuthe J, De Somer C, Hulzinga F, Ginis P, Schlenstedt C, Nieuwboer A. Dual Task Turning in Place: A Reliable, Valid, and Responsive Outcome Measure of Freezing of Gait. Mov Disord. 2022 Feb;37(2):269-278. doi: 10.1002/mds.28887. Epub 2021 Dec 22.
PubMed 34939224D'Cruz N, Seuthe J, Ginis P, Hulzinga F, Schlenstedt C, Nieuwboer A. Short-Term Effects of Single-Session Split-Belt Treadmill Training on Dual-Task Performance in Parkinson's Disease and Healthy Elderly. Front Neurol. 2020 Sep 30;11:560084. doi: 10.3389/fneur.2020.560084. eCollection 2020.
PubMed 33101174
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05511597
- Acronym / sponsor ID
- SBT FOG-TRAIN / S65984
- Conditions
- Parkinson Disease, Freezing of Gait, Split-belt Treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 23 Aug 2022 (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.
A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised single-blind parallel-group study
| Arm | Type | Receives |
|---|---|---|
| SBT+CP | Experimental | Behavioral: Split-belt treadmill training, Behavioral: Complex task practiceSplit-belt training + complex task practice |
| SBT+PL | Active comparator | Behavioral: Split-belt treadmill training, Behavioral: Upper-limb coordination and powerSplit-belt training + upper-limb exercise |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Split-belt treadmill trainingSplit-belt walking with various speed ratios between the two legs, applied with random-block practice | Behavioural | SBT+CP, SBT+PL |
| Complex task practiceOverground gait flexibility training with added cognitive tasks | Behavioural | SBT+CP |
| Upper-limb coordination and powerDynamic upper-limb mobility, coordination and power exercises with dual-tasking | Behavioural | SBT+PL |
Primary outcome
Percentage Time Frozen during turning in place
Time frame: up to 8 weeks post intervention
Percentage Time Frozen scored from video of rapid alternating full turns in place. Based on earlier work showing immediate effects of SBT training on FOG during this task.
Time to complete Timed Up and Go (TUG)
Time frame: up to 8 weeks post intervention
Overall time to complete the Timed Up and Go task. The training is expected to improve multiple transitions between straight walking and turning and should be reflected in the overall task time.
2 secondary outcomes
Percentage Time Frozen over all FOG-provoking tasks
Time frame: up to 8 weeks post intervention
Percentage Time Frozen over 1-week free-living monitoring
Time frame: up to 8 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 34939224D'Cruz N, Seuthe J, De Somer C, Hulzinga F, Ginis P, Schlenstedt C, Nieuwboer A. Dual Task Turning in Place: A Reliable, Valid, and Responsive Outcome Measure of Freezing of Gait. Mov Disord. 2022 Feb;37(2):269-278. doi: 10.1002/mds.28887. Epub 2021 Dec 22.
- Background: PubMed 33101174D'Cruz N, Seuthe J, Ginis P, Hulzinga F, Schlenstedt C, Nieuwboer A. Short-Term Effects of Single-Session Split-Belt Treadmill Training on Dual-Task Performance in Parkinson's Disease and Healthy Elderly. Front Neurol. 2020 Sep 30;11:560084. doi: 10.3389/fneur.2020.560084. eCollection 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alice Nieuwboer, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-belt treadmill training, Complex task practice and Upper-limb coordination and power in people with Parkinson Disease and Freezing of Gait, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 3 Sep 2026. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Time Frozen during turning in place (time frame: up to 8 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511597, which also lists 2 linked publications.
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 3 Sep 2026.