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

NCT04946812 | Active Not Recruiting

• 1 other identifier: 19-6049
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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'.

Conditions

Parkinson Disease; Freezing of Gait; Gait, Unsteady

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Gait parameters between intervention and control groups

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

• Gait parameters between intervention and control groups

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

• Gait parameters between intervention and control groups

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

• Gait parameters between intervention and control groups

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

• Gait parameters between intervention and control groups

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

Study Arms (2)

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).

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).

Other: Split-belt treadmill training

Interventions

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%.

Control group; Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a prospective, single-blind, parallel-group randomized control trial to assess the feasibility and safety of SBTM in preventing falls and improving gait and balance, as well as its efficacy compared to TM training. The assessor will be blinded to their randomization. Patients will not be blinded to the intervention, and will be informed about the rationale of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator, Staff Neurologist

Model Details: Split-belt treadmill (Grail systems®, by Motek, Netherlands)

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: July 1, 2021
• Study Start: March 27, 2020
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CA (1)