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NCT Number: NCT04946812

Split-belt Treadmill Training to Rehabilitate Freezing of Gait and Balance in Parkinson's Disease

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'.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Freezing of Gait Gait Disorders, Neurologic Gait, Unsteady Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Split-belt treadmill training

Other

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%.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Cadence (steps per minute)

  2. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Stride time (time elapsed between the first contact of two consecutive footsteps of the same foot in milliseconds)

  3. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Duration of stance (time during which the foot is in contact with the ground) o

  4. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Swing (swing phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again)

  5. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Double limb support phase (he subperiod during which both feet are in contact with the ground)

  6. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Step length, calculated by multiplying the 'step time' and 'belt speed'

  7. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Step width height (the mediolateral space between the two feet)

  8. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Kinemetics of joint excursion (expression as degree of range of motion)

  9. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    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)

  10. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Ratio of single support time/ double support time, which reflects dynamic stability

  11. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Symmetry ratio (best leg step length/worst step)

  12. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    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

  13. Gait parameters between intervention and control groups

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Sequence effect (progressive reduction in step length), measured by a linear regression slope determined by plotting consecutive stride time intervals against stride number

  14. Health-related quality of life

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    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

  15. Balance and postural stability

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    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.

  16. Freezing of gait

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    Measured by the new freezing of gait questionnaire (NFOGQ).The total score ranges from 0 to 24, and higher scores denote more severe FOG.

  17. Parkinson's disease signs and symptoms

    Time frame: Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention

    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

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 1, 2021
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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