Parkinson DiseaseNCT04946812
Split-belt Treadmill Training to Rehabilitate Freezing of Gait and Balance in Parkinson's Disease
A study testing Split-belt treadmill training in people with Parkinson Disease and Freezing of Gait, run by University of Toronto at 1 site in Canada.
Trial summary
Parkinson's disease (PD) related gait and balance disorders are challenging to treat because they cannot be optimized with pharmacological intervention alone. This treatment gap is important to address because gait asymmetry and incoordination are associated with increased falls in this population, which can be… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Freezing of Gait, Gait, Unsteady
- What is being tested?
- Split-belt treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 27 Mar 2020to Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic PD
- Hoehn \& Yahr Stage 2-3, on levodopa
- FOG, resistant to dopaminergic therapy
- Disease duration: 5-15 years
- Stable clinical response to medications or stimulation parameters (in case of DBS) for at least 3 months
- MMSE >24/30
- Able to walk on a motor-driven treadmill
Who cannot join
- Severe imbalance that limits ambulation (Hoehn \&Yahr score above 3)
- Orthopedic conditions and other systemic disease affecting locomotion
- Cardiac conditions limiting the ability to walk uninterrupted for 1 hour
- Presence of other neurological disorder
- Inability to be fluent in English
Trial locations and contacts
1 site in 1 country.
About this study
Parkinson's disease (PD) related gait and balance disorders are challenging to treat because they cannot be optimized with pharmacological intervention alone. This treatment gap is important to address because gait asymmetry and incoordination are associated with increased falls in this population, which can be functionally debilitating and lead to increased morbidity and mortality. Freezing of gait (FOG) has also been associated with reduced quality of life independent of its association with impaired mobility. Gait disorders therefore represent an unmet need in the treatment of PD. A split-belt treadmill (SB-TM) can be used to adjust the speed of each leg separately and individuals can be prompted to 'adapt' to an asymmetric gait and 're-adapt' with return to symmetrical gait in a phenomenon known as 'after-effect'.
Read the detailed description
Parkinson's disease (PD) related gait and balance disorders are challenging to treat because they cannot be optimized with pharmacological intervention alone. This treatment gap is important to address because gait asymmetry and incoordination are associated with increased falls in this population, which can be functionally debilitating and lead to increased morbidity and mortality. Freezing of gait (FOG) has also been associated with reduced quality of life independent of its association with impaired mobility. Gait disorders therefore represent an unmet need in the treatment of PD.
Physiotherapy with treadmill training is a means to address the limitations of pharmacotherapy in this population. Treadmill training increases stride length, lowers cadence and improves foot clearance; long-term treadmill training results in clinically improved gait velocity and postural stability. The advent of SB-TM training can further optimize the gait instability that arises from asymmetric pathology in this population. The SB-TM has 2 belts, which can either move in unison (tied) or at different speeds (split), and it has been effective in restoring symmetrical gait in the stroke population, with gait adaptations retained for up to 3 months. The motor symptoms in PD develop asymmetrically, with the burden of symptoms often lateralizing to one side, so the SB-TM offers a unique opportunity to modulate spatial and temporal gait parameters to study gait adaptation in the PD population.
Split-belt treadmill training uses the concept of adaptive learning, which is error-driven motor leaning in response to changes in the external environment. It can be used to target specific gait deviations, and preliminary research has indicated that it can improve gait disorders in PD by decreasing limb asymmetry. Adaptive learning occurs when there is an adjustment of leg-speed perception during locomotor movement. When using a split-belt treadmill (SB-TM) to adjust the speed of each leg, the step length and double support time during gait can be manipulated. Individuals can therefore be prompted to 'adapt' to the asymmetric gait (e.g., the leg walking on a slow belt will take longer steps to accommodate to the leg walking on the faster belt) and 're-adapt' with return to symmetrical gait.
This method of rehabilitation can therefore be used to treat a range gait abnormalities and previous research has demonstrated the ability to restore symmetrical gait and reduced falls for up to 3 months in the stroke population. A preliminary study from our lab in individuals with PD and FOG demonstrated that velocity reduction by 25% on the least affected side resulted in a more symmetric and coordinated gait after 10 minutes of SB-TM training.
- Conditions
- Parkinson Disease, Freezing of Gait, Gait, Unsteady
- Being tested
- Split-belt treadmill training
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-belt treadmill trainingOther
18 sessions of SB-TM training, where the velocity of the belt will be adjusted to the over-ground speed of the subject, and will be reduced on the least affected side by 25%.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The velocity of the belt will be adjusted to the over-ground speed of the subject, and will be reduced on the least affected side by 25%. While the speed of the treadmill will not change throughout the study, the duration of the training will increase each week. In the first week, the SBTM training will take place for 10 minutes. There will be a 5-minute rest period, and the split-belt conditions will continue for another 10 minutes of training (total training time= 20 minutes). Receives: Other: Split-belt treadmill training |
| Control group | Active comparator | The subject will continue to walk under tied-belt conditions adjusted to the over-ground walking speed. In the first week, the treadmill training will be for 10 minutes. They will get a 5-minute break, similar to the intervention group, and continue for another 10 minutes under tied-belt conditions.
The duration of each session will increase by 8 minutes every week. For example, in week 1, the treadmill training will be for a total of 20 minutes; in week 2, for 28 minutes; in week 3, for 36 minutes, and so forth, until it gets to 60 minutes by week 6. The rest period will remain at 5 minutes each session, and will always take place at the halfway mark. All 3 sessions in the week will have the same duration of training.
If the subject cannot tolerate the velocity or duration of the session, the protocol will be adjusted to most recently tolerated session (and will be recorded for further interpretation and analysis). Receives: Other: Split-belt treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
The incidence of falls for 3 months after completing treadmill training. Falls will also be assessed at multiple stages during the 7.5-month study period, to understand the duration of benefit of this intervention. This data will be obtained from the falls calendar that will be provided to subjects upon their recruitment to the study.
Measured: 3 months after completion of treadmill training
Secondary outcomes (17)
Gait parameters between intervention and control groups
Cadence (steps per minute)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Stride time (time elapsed between the first contact of two consecutive footsteps of the same foot in milliseconds)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Duration of stance (time during which the foot is in contact with the ground) o
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Swing (swing phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Double limb support phase (he subperiod during which both feet are in contact with the ground)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Step length, calculated by multiplying the 'step time' and 'belt speed'
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Step width height (the mediolateral space between the two feet)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Kinemetics of joint excursion (expression as degree of range of motion)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Foot angle (the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Ratio of single support time/ double support time, which reflects dynamic stability
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Symmetry ratio (best leg step length/worst step)
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Coefficients of variation (which measures the variability of the temporal parameters of the swing phase duration and gait cycle time, and is represented by the (SD/mean) x100
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Sequence effect (progressive reduction in step length), measured by a linear regression slope determined by plotting consecutive stride time intervals against stride number
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Health-related quality of life
Measured by the Parkinson's Disease Questionnaire-39 item self-report questionnaire (PDQ-39), scored out of 100 where a higher score reflects greater impact on quality of life
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Balance and postural stability
Measured by the Activities-specific Balance and Confidence (ABC) scale, possible range = 0 to 1600, Scores lower than 50 indicate a low level of functioning, scores above 50 but below 80 indicate a medium level, and those over 80 indicate a high level of functioning.
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Freezing of gait
Measured by the new freezing of gait questionnaire (NFOGQ).The total score ranges from 0 to 24, and higher scores denote more severe FOG.
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Parkinson's disease signs and symptoms
Assessed by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The maximum total UPDRS score is 199, indicating the worst possible disability from PD
Measured: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start27 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (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.
- More trials run by University of TorontoThe 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
- Split-belt treadmill (Grail systems®, by Motek, Netherlands)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946812
- Sponsor's protocol ID
- 19-6049
- Status last verified
- Jul 2024
- First submitted
- 12 Jun 2021
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-belt Treadmill Training to Rehabilitate Freezing of Gait and Balance in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04946812
- Acronym / sponsor ID
- 19-6049
- Conditions
- Parkinson Disease, Freezing of Gait, Gait, Unsteady
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Jul 2021 (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) related gait and balance disorders are challenging to treat because they cannot be optimized with pharmacological intervention alone. This treatment gap is important to address because gait asymmetry and incoordination are associated with increased falls in this population, which can be functionally debilitating and lead to increased morbidity and mortality. Freezing of gait (FOG) has also been associated with reduced quality of life independent of its association with impaired mobility. Gait disorders therefore represent an unmet need in the treatment of PD. A split-belt treadmill (SB-TM) can be used to adjust the speed of each leg separately and individuals can be prompted to 'adapt' to an asymmetric gait and 're-adapt' with return to symmetrical gait in a phenomenon known as 'after-effect'.
Detailed description
Parkinson's disease (PD) related gait and balance disorders are challenging to treat because they cannot be optimized with pharmacological intervention alone. This treatment gap is important to address because gait asymmetry and incoordination are associated with increased falls in this population, which can be functionally debilitating and lead to increased morbidity and mortality. Freezing of gait (FOG) has also been associated with reduced quality of life independent of its association with impaired mobility. Gait disorders therefore represent an unmet need in the treatment of PD.
Physiotherapy with treadmill training is a means to address the limitations of pharmacotherapy in this population. Treadmill training increases stride length, lowers cadence and improves foot clearance; long-term treadmill training results in clinically improved gait velocity and postural stability. The advent of SB-TM training can further optimize the gait instability that arises from asymmetric pathology in this population. The SB-TM has 2 belts, which can either move in unison (tied) or at different speeds (split), and it has been effective in restoring symmetrical gait in the stroke population, with gait adaptations retained for up to 3 months. The motor symptoms in PD develop asymmetrically, with the burden of symptoms often lateralizing to one side, so the SB-TM offers a unique opportunity to modulate spatial and temporal gait parameters to study gait adaptation in the PD population.
Split-belt treadmill training uses the concept of adaptive learning, which is error-driven motor leaning in response to changes in the external environment. It can be used to target specific gait deviations, and preliminary research has indicated that it can improve gait disorders in PD by decreasing limb asymmetry. Adaptive learning occurs when there is an adjustment of leg-speed perception during locomotor movement. When using a split-belt treadmill (SB-TM) to adjust the speed of each leg, the step length and double support time during gait can be manipulated. Individuals can therefore be prompted to 'adapt' to the asymmetric gait (e.g., the leg walking on a slow belt will take longer steps to accommodate to the leg walking on the faster belt) and 're-adapt' with return to symmetrical gait.
This method of rehabilitation can therefore be used to treat a range gait abnormalities and previous research has demonstrated the ability to restore symmetrical gait and reduced falls for up to 3 months in the stroke population. A preliminary study from our lab in individuals with PD and FOG demonstrated that velocity reduction by 25% on the least affected side resulted in a more symmetric and coordinated gait after 10 minutes of SB-TM training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-belt treadmill (Grail systems®, by Motek, Netherlands)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Split-belt treadmill trainingThe velocity of the belt will be adjusted to the over-ground speed of the subject, and will be reduced on the least affected side by 25%. While the speed of the treadmill will not change throughout the study, the duration of the training will increase each week. In the first week, the SBTM training will take place for 10 minutes. There will be a 5-minute rest period, and the split-belt conditions will continue for another 10 minutes of training (total training time= 20 minutes). |
| Control group | Active comparator | Other: Split-belt treadmill trainingThe subject will continue to walk under tied-belt conditions adjusted to the over-ground walking speed. In the first week, the treadmill training will be for 10 minutes. They will get a 5-minute break, similar to the intervention group, and continue for another 10 minutes under tied-belt conditions. The duration of each session will increase by 8 minutes every week. For example, in week 1, the treadmill training will be for a total of 20 minutes; in week 2, for 28 minutes; in week 3, for 36 minutes, and so forth, until it gets to 60 minutes by week 6. The rest period will remain at 5 minutes each session, and will always take place at the halfway mark. All 3 sessions in the week will have the same duration of training. If the subject cannot tolerate the velocity or duration of the session, the protocol will be adjusted to most recently tolerated session (and will be recorded for further interpretation and analysis). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Idiopathic PD
- Hoehn \& Yahr Stage 2-3, on levodopa
- FOG, resistant to dopaminergic therapy
- Disease duration: 5-15 years
- Stable clinical response to medications or stimulation parameters (in case of DBS) for at least 3 months
Key exclusion criteria (5 listed)
- Severe imbalance that limits ambulation (Hoehn \&Yahr score above 3)
- Orthopedic conditions and other systemic disease affecting locomotion
- Cardiac conditions limiting the ability to walk uninterrupted for 1 hour
- Presence of other neurological disorder
- Inability to be fluent in English
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 training18 sessions of SB-TM training, where the velocity of the belt will be adjusted to the over-ground speed of the subject, and will be reduced on the least affected side by 25%. | Other | Control group, Intervention group |
Primary outcome
Falls
Time frame: 3 months after completion of treadmill training
The incidence of falls for 3 months after completing treadmill training. Falls will also be assessed at multiple stages during the 7.5-month study period, to understand the duration of benefit of this intervention. This data will be obtained from the falls calendar that will be provided to subjects upon their recruitment to the study.
17 secondary outcomes
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Gait parameters between intervention and control groups
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Health-related quality of life
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Balance and postural stability
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Freezing of gait
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Parkinson's disease signs and symptoms
Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Parkinson Disease and Freezing of Gait, run by University of Toronto at 1 site in Canada.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. 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 Canada. 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?
Results are not available in the source record.
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?
Falls (time frame: 3 months after completion of treadmill training). 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 17 Jul 2024.