Back to resultsHow to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Postural control (weight shift) training
Steady state gait training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Freezing of Gait, Gait Initiation
Eligibility Criteria
Inclusion Criteria: Diagnosis of idiopathic Parkinson disease characterized by asymmetrical onset of at least 2 of 3 cardinal signs (resting tremor, bradykinesia, or rigidity) with no atypical signs or exposure to dopamine-blocking drugs The presence of mild to moderate gait or balance impairment (a rating of 1-2 on MDS Unified Parkinson Disease Rating Scale (MDS-UPDRS) item 10 [gait] or rating 1-3 on item 12 [postural stability] Hoehn & Yahr stages 1-3 ("on" for those who fluctuate) Self-report of difficulty with freezing of gait (i.e., a rating of 1-4 on question 3 of the Freezing of Gait Questionnaire) All participants must be able to walk > 5 minutes at greater than or equal to 80% of comfortable gait speed (CGS) on the treadmill and > 5 minutes over ground without assistance or an assistive device. Exclusion Criteria: Uncontrolled cardiorespiratory/metabolic disease, vestibular dysfunction that may affect gait or balance Parkinson's related or unrelated dementia (i.e. Montreal Cognitive Assessment score <21) Comfortable over ground walking speed of less than 0.5m/s History of traumatic brain injury self-reported deafness or blindness as this would impair the patient's ability to hear cues or ambulate safely within the lab environment other neurological disorders or orthopedic injury that may affect gait recent orthopedic surgery (in the last 6 months) Participants will also be excluded if they have severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures Participants who are currently receiving supervised physical therapy services
Sites / Locations
- UNC Chapel HillRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Postural control (weight shifting) training followed by steady state gait training.
Steady state gait training followed by postural control (weight shifting) training.
Arm Description
For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions. To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training. Each training will be three times per week for two weeks. There is a one week break between the two trainings.
To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training. For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions. Each training will be three times per week for two weeks. There is a one week break between the two trainings.
Outcomes
Primary Outcome Measures
Change in First Step Length from Baseline to Conclusion of the first block of training
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Change in First Step Length from end of first block of training to training 2 pre-test
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Change in First Step Length from training block 2 pre-test to conclusion of second block of training
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Change in First Step Length from conclusion of second training block to 1 week follow up from second training block
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Secondary Outcome Measures
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from Baseline to Conclusion of the first block of training
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from end of first block of training to training 2 pre-test
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from training block 2 pre-test to conclusion of second block of training
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from conclusion of second training block to 1 week follow up from second training block
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Change in First Step Speed from Baseline to Conclusion of the first block of training
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Change in First Step Speed from end of first block of training to training 2 pre-test
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Change in First Step Speed from training block 2 pre-test to conclusion of second block of training
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Full Information
NCT ID
NCT05625789
First Posted
November 15, 2022
Last Updated
January 6, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
LSVT Global
1. Study Identification
Unique Protocol Identification Number
NCT05625789
Brief Title
How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
Official Title
How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
LSVT Global
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to understand the treatment approach (i.e., targeting gait or targeting the postural adjustment prior to gait) that is most effective at improving gait initiation dynamics in people with Parkinson disease. Ten adults with idiopathic Parkinson disease who self-report difficulty initiating gait will complete the study. The investigators will be using a randomized crossover design, where the participants will participate in two series of training (i.e., postural training and steady-state gait training) with a one-week washout between trainings. Investigators will evaluate the changes induced in gait initiation postural adjustment size, first step length, and first step speed from each intervention. Due to the anticipated limitation of steady-state walking to directly address postural adjustment amplitude, it is hypothesized that training for larger amplitude weight shift during gait initiation will yield improved gait initiation dynamics compared to training with large amplitude movements during steady-state walking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Freezing of Gait, Gait Initiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postural control (weight shifting) training followed by steady state gait training.
Arm Type
Experimental
Arm Description
For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions.
To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training.
Each training will be three times per week for two weeks. There is a one week break between the two trainings.
Arm Title
Steady state gait training followed by postural control (weight shifting) training.
Arm Type
Experimental
Arm Description
To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training.
For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions.
Each training will be three times per week for two weeks. There is a one week break between the two trainings.
Intervention Type
Behavioral
Intervention Name(s)
Postural control (weight shift) training
Intervention Description
Visual cues to improve amplitude of weight shift prior to initiating gait.
Intervention Type
Behavioral
Intervention Name(s)
Steady state gait training
Intervention Description
Auditory cues are provided to increase amplitude of movement (e.g., step length) during continuous walking, to determine its effects on gait initiation amplitude of movement.
Primary Outcome Measure Information:
Title
Change in First Step Length from Baseline to Conclusion of the first block of training
Description
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Time Frame
Baseline, at the conclusion of the first block of training (approximately 2 weeks)
Title
Change in First Step Length from end of first block of training to training 2 pre-test
Description
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Time Frame
Conclusion of first training block, just prior to beginning the second training series (1 week)
Title
Change in First Step Length from training block 2 pre-test to conclusion of second block of training
Description
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Time Frame
Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
Title
Change in First Step Length from conclusion of second training block to 1 week follow up from second training block
Description
Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).
Time Frame
Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
Secondary Outcome Measure Information:
Title
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from Baseline to Conclusion of the first block of training
Description
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Time Frame
Baseline, at the conclusion of the first block of training (approximately 2 weeks)
Title
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from end of first block of training to training 2 pre-test
Description
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Time Frame
Conclusion of first training block, just prior to beginning the second training series (1 week)
Title
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from training block 2 pre-test to conclusion of second block of training
Description
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Time Frame
Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
Title
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from conclusion of second training block to 1 week follow up from second training block
Description
Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).
Time Frame
Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
Title
Change in First Step Speed from Baseline to Conclusion of the first block of training
Description
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Time Frame
Baseline, at the conclusion of the first block of training (approximately 2 weeks)
Title
Change in First Step Speed from end of first block of training to training 2 pre-test
Description
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Time Frame
Conclusion of first training block, just prior to beginning the second training series (1 week)
Title
Change in First Step Speed from training block 2 pre-test to conclusion of second block of training
Description
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Time Frame
Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
Title
Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block
Description
First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.
Time Frame
Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic Parkinson disease characterized by asymmetrical onset of at least 2 of 3 cardinal signs (resting tremor, bradykinesia, or rigidity) with no atypical signs or exposure to dopamine-blocking drugs
The presence of mild to moderate gait or balance impairment (a rating of 1-2 on MDS Unified Parkinson Disease Rating Scale (MDS-UPDRS) item 10 [gait] or rating 1-3 on item 12 [postural stability]
Hoehn & Yahr stages 1-3 ("on" for those who fluctuate)
Self-report of difficulty with freezing of gait (i.e., a rating of 1-4 on question 3 of the Freezing of Gait Questionnaire)
All participants must be able to walk > 5 minutes at greater than or equal to 80% of comfortable gait speed (CGS) on the treadmill and > 5 minutes over ground without assistance or an assistive device.
Exclusion Criteria:
Uncontrolled cardiorespiratory/metabolic disease, vestibular dysfunction that may affect gait or balance
Parkinson's related or unrelated dementia (i.e. Montreal Cognitive Assessment score <21)
Comfortable over ground walking speed of less than 0.5m/s
History of traumatic brain injury
self-reported deafness or blindness as this would impair the patient's ability to hear cues or ambulate safely within the lab environment
other neurological disorders or orthopedic injury that may affect gait
recent orthopedic surgery (in the last 6 months)
Participants will also be excluded if they have severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures
Participants who are currently receiving supervised physical therapy services
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsea Duppen, DPT
Phone
919-966-4041
Email
chelsea_parker@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Lewek, PhD
Phone
919-966-9732
Email
mlewek@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lewek, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chelsea P Duppen, DPT
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lewek, PhD
Phone
919-966-9732
Email
michael_lewek@med.unc.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning after publication to five years following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Results will be shared following publication and up to five years following publication.
IPD Sharing Access Criteria
The investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and must execute a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Learn more about this trial
How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
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