Parkinson DiseaseNCT03725215
Motor Adaptation to Split-Belt Treadmill in Parkinson's Disease
A study testing Split-Belt Treadmill Training in people with Parkinson Disease and Freezing of Gait, run by KU Leuven at 2 sites in 2 countries.
Trial summary
Freezing of Gait (FOG) is a disabling symptom common in advanced Parkinson's Disease. FOG is an independent contributor to fall risk and is only partially relieved by medication. Parkinson's patients with FOG are known to have more difficulty with gait adaptation in their day to day environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- Split-Belt Treadmill Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2017to 30 Jun 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's Disease as per the UK Parkinson's Disease Society Brain Bank Criteria
- Classification as a Freezer with the New Freezing of Gait Questionnaire (score > 0)
- Ability to walk at least 5 min. without any aid
- Stable anti-parkinsonian medication at least 1 month prior to participation
Who cannot join
- Neurologic diseases other than PD
- Orthopedic injuries that could influence gait and balance
- Participation in treadmill training more than once a week
- Cognitive impairment (MMSE<24) or inability to follow test instructions
- Self-reported DBS-related postural or gait disturbances
- Cardiovascular risk factors
- Peripheral neuropathy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Faculty of Movement and Rehabilitation Sciences (FaBeR)
Leuven, 3001
About this study
Official title: Influence of Multiple Ratio Split-belt Treadmill on Gait Asymmetry and Motor Learning in PD Patients With Freezing of Gait
Freezing of Gait (FOG) is a disabling symptom common in advanced Parkinson's Disease. FOG is an independent contributor to fall risk and is only partially relieved by medication. Parkinson's patients with FOG are known to have more difficulty with gait adaptation in their day to day environment. Further, asymmetry of gait has been implicated in FOG as these episodes are often elicited during asymmetric tasks such as turning. This study will examine the effect of a single session of split-belt treadmill walking on gait adaptation, gait symmetry and FOG as well as 24 hour retention of these effects.
Read the detailed description
In this proposal, the investigators will investigate whether adapting gait to modulations imposed by a split-belt treadmill, improves walking ability and reduces FOG. The investigators will test the hypothesis that motor adaptation deficits underlie FOG and that these problems are modifiable with training. To address these suppositions, the investigators propose a multi-centric study conducted in two research labs with expertise in split-belt gait analysis and FOG: University of Leuven (KUL) and Christian-Albrechts-University Kiel (CAUK). As freezers have been shown to have more difficulty with consolidation of motor learning, the investigators aim in study I (pilot phase) to first understand which split-belt parameters are optimal for training gait flexibility and lead to consolidated gains in daily walking. For this study, the investigators will recruit 60 freezers and 60 healthy controls, pooled across centers, and manipulate different split-belt conditions in one learning and retention session.
- Conditions
- Parkinson Disease, Freezing of Gait
- Being tested
- Split-Belt Treadmill Training
- Keywords
- Split-Belt Treadmill, Training
- 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
One session of 6 x 5 min with 1 min intervals.
| Study group | Role | What they receive |
|---|---|---|
| Split-Belt Treadmill Training 1:2 | Experimental | Split-Belt Training with a steady ratio of 1:2. Receives: Behavioral: Split-Belt Treadmill Training |
| Split-Belt Treadmill Training 3:4 | Experimental | Split-Belt Training with a steady ratio of 3:4. Receives: Behavioral: Split-Belt Treadmill Training |
| Split-Belt Treadmill Training Changing | Experimental | Split-Belt Training with changing ratios between 3:4 to 1:2. Receives: Behavioral: Split-Belt Treadmill Training |
| Split-Belt Treadmill Training Tied-Belt | Active comparator | Split-Belt Training with tied belts. Receives: Behavioral: Split-Belt Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation to Split/Tied Belt
Measured with 3D motion analysis system during treadmill walking. Patients will walk for 1.5 minutes on the treadmill that will switch from tied-to-split state and back to tied state.
Measured: 24 hours after training
Gait Asymmetry
Measured with 3D motion analysis system during straight line overground walking
Measured: 24 hours after training
Freezing Ratio
Measured with APDM sensors during 360 degree turns
Measured: 24 hours after training
Secondary outcomes (2)
Medio-lateral Anticipatory Postural Adjustments
Measured with APDM sensors at gait initiation
Measured: 24 hours after training
Gait Speed during dual task walking
Measured with 3D motion analysis system during overground walking with an auditory Stroop task
Measured: 24 hours after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Participants will randomly be assigned to 1 of 4 different split-belt treadmill paradigms. Assessments will be performed pre and post training on day 1 and once again on day 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel
- Responsible party
- Principal investigator, Alice Nieuwboer, KU Leuven
- Investigators
- Alice Nieuwboer, PhD, Principal investigator, KU LeuvenChristian Schlenstedt, PhD, Principal investigator, CAU Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725215
- Sponsor's protocol ID
- S60876
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seuthe J, D'Cruz N, Ginis P, Becktepe JS, Weisser B, Nieuwboer A, Schlenstedt C. The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait. Neurorehabil Neural Repair. 2020 Oct;34(10):954-963. doi: 10.1177/1545968320953144. Epub 2020 Sep 17.
PubMed 32940131
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Multiple Ratio Split-belt Treadmill on Gait Asymmetry and Motor Learning in PD Patients With Freezing of Gait
- ClinicalTrials.gov ID
- NCT03725215
- Acronym / sponsor ID
- S60876
- Conditions
- Parkinson Disease, Freezing of Gait
- Keywords
- Split-Belt Treadmill, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University of Kiel
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Oct 2018 (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.
Freezing of Gait (FOG) is a disabling symptom common in advanced Parkinson's Disease. FOG is an independent contributor to fall risk and is only partially relieved by medication. Parkinson's patients with FOG are known to have more difficulty with gait adaptation in their day to day environment. Further, asymmetry of gait has been implicated in FOG as these episodes are often elicited during asymmetric tasks such as turning. This study will examine the effect of a single session of split-belt treadmill walking on gait adaptation, gait symmetry and FOG as well as 24 hour retention of these effects.
Detailed description
In this proposal, the investigators will investigate whether adapting gait to modulations imposed by a split-belt treadmill, improves walking ability and reduces FOG. The investigators will test the hypothesis that motor adaptation deficits underlie FOG and that these problems are modifiable with training. To address these suppositions, the investigators propose a multi-centric study conducted in two research labs with expertise in split-belt gait analysis and FOG: University of Leuven (KUL) and Christian-Albrechts-University Kiel (CAUK). As freezers have been shown to have more difficulty with consolidation of motor learning, the investigators aim in study I (pilot phase) to first understand which split-belt parameters are optimal for training gait flexibility and lead to consolidated gains in daily walking. For this study, the investigators will recruit 60 freezers and 60 healthy controls, pooled across centers, and manipulate different split-belt conditions in one learning and retention session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will randomly be assigned to 1 of 4 different split-belt treadmill paradigms. Assessments will be performed pre and post training on day 1 and once again on day 2.
| Arm | Type | Receives |
|---|---|---|
| Split-Belt Treadmill Training 1:2 | Experimental | Behavioral: Split-Belt Treadmill TrainingSplit-Belt Training with a steady ratio of 1:2. |
| Split-Belt Treadmill Training 3:4 | Experimental | Behavioral: Split-Belt Treadmill TrainingSplit-Belt Training with a steady ratio of 3:4. |
| Split-Belt Treadmill Training Changing | Experimental | Behavioral: Split-Belt Treadmill TrainingSplit-Belt Training with changing ratios between 3:4 to 1:2. |
| Split-Belt Treadmill Training Tied-Belt | Active comparator | Behavioral: Split-Belt Treadmill TrainingSplit-Belt Training with tied belts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's Disease as per the UK Parkinson's Disease Society Brain Bank Criteria
- Classification as a Freezer with the New Freezing of Gait Questionnaire (score > 0)
- Ability to walk at least 5 min. without any aid
- Stable anti-parkinsonian medication at least 1 month prior to participation
Key exclusion criteria (7 listed)
- Neurologic diseases other than PD
- Orthopedic injuries that could influence gait and balance
- Participation in treadmill training more than once a week
- Cognitive impairment (MMSE<24) or inability to follow test instructions
- Self-reported DBS-related postural or gait disturbances
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 TrainingOne session of 6 x 5 min with 1 min intervals. | Behavioural | Split-Belt Treadmill Training 1:2, Split-Belt Treadmill Training 3:4, Split-Belt Treadmill Training Changing, Split-Belt Treadmill Training Tied-Belt |
Primary outcome
Adaptation to Split/Tied Belt
Time frame: 24 hours after training
Measured with 3D motion analysis system during treadmill walking. Patients will walk for 1.5 minutes on the treadmill that will switch from tied-to-split state and back to tied state.
Gait Asymmetry
Time frame: 24 hours after training
Measured with 3D motion analysis system during straight line overground walking
Freezing Ratio
Time frame: 24 hours after training
Measured with APDM sensors during 360 degree turns
2 secondary outcomes
Medio-lateral Anticipatory Postural Adjustments
Time frame: 24 hours after training
Gait Speed during dual task walking
Time frame: 24 hours after training
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 8 Aug 2019.
- Derived from this study: PubMed 32940131Seuthe J, D'Cruz N, Ginis P, Becktepe JS, Weisser B, Nieuwboer A, Schlenstedt C. The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait. Neurorehabil Neural Repair. 2020 Oct;34(10):954-963. doi: 10.1177/1545968320953144. Epub 2020 Sep 17.
- 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
Christian Schlenstedt, PhD principal investigator
CAU Kiel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-Belt Treadmill Training in people with Parkinson Disease and Freezing of Gait, run by KU Leuven at 2 sites in 2 countries.
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 7 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: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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?
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?
Adaptation to Split/Tied Belt (time frame: 24 hours after training). 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?
On the ClinicalTrials.gov record for NCT03725215, which also lists 1 linked publication.
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 8 Aug 2019.