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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04946812
Other study ID # 19-6049
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2020
Est. completion date June 2023

Study information

Verified date November 2022
Source University of Toronto
Contact Alfonso Fasano, MD, PhD
Phone (416) 603-5800
Email alfonso.fasano@uhn.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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'.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date June 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Idiopathic PD 2. Hoehn & Yahr Stage 2-3, on levodopa 3. FOG, resistant to dopaminergic therapy 4. Disease duration: 5-15 years 5. Stable clinical response to medications or stimulation parameters (in case of DBS) for at least 3 months 6. MMSE >24/30 7. Able to walk on a motor-driven treadmill Exclusion Criteria: 1. Severe imbalance that limits ambulation (Hoehn &Yahr score above 3) 2. Orthopedic conditions and other systemic disease affecting locomotion 3. Cardiac conditions limiting the ability to walk uninterrupted for 1 hour 4. Presence of other neurological disorder 5. Inability to be fluent in English

Study Design


Intervention

Other:
Split-belt treadmill training
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%.

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months after completion of treadmill training
Secondary Gait parameters between intervention and control groups Cadence (steps per minute) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Duration of stance (time during which the foot is in contact with the ground) o Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Double limb support phase (he subperiod during which both feet are in contact with the ground) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Step length, calculated by multiplying the 'step time' and 'belt speed' Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Step width height (the mediolateral space between the two feet) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Kinemetics of joint excursion (expression as degree of range of motion) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Ratio of single support time/ double support time, which reflects dynamic stability Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary Gait parameters between intervention and control groups Symmetry ratio (best leg step length/worst step) Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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 Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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 Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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 Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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. Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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. Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Secondary 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 Obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
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