Post-stroke Perturbation Training
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reactive Perturbations
Proactive Perturbations
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Experience of a stroke at least 6 months prior to participation
- Self-reported experience of a fall in the previous year, and/or a fear of falling
- Gait speed of at least 0.2 m/s
- Ability to walk on a treadmill without a cane or walker
- Provision of informed consent
Exclusion Criteria:
- Evidence of cerebellar damage
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological disorders or dementia
- Legal blindness or severe visual impairment
- History of DVT or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Reactive Perturbations
Proactive Perturbations
Arm Description
Outcomes
Primary Outcome Measures
Fall incidence
A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.
Secondary Outcome Measures
Fear of falling
Participants will be asked if they have a fear of falling (yes/no).
Functional Gait Assessment
A common clinical measure of gait balance
Activities-specific Balance Confidence scale
A common clinical measure of balance self-efficacy
Walking speed
Participants will be instructed to walk overground along a 10-meter path at the speed they would normally use around their house of the store. Speed will be measured for the middle 6-meters of the path.
Foot placement stabilization strategy (mechanics)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and step width at the end of the step, accounting for pelvis velocity.
Foot placement stabilization strategy (gluteus medius activity)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of gluteus medius activity during the first half of the swing phase, accounting for pelvis velocity.
Center of pressure shift stabilization strategy (mechanics)
We will calculate the partial correlation between the pelvis velocity at the start of each step, and the magnitude of the change in mediolateral center of pressure location under the stance foot during the step, accounting for pelvis displacement.
Center of pressure shift stabilization strategy (peroneus longus activity)
We will calculate the partial correlation between the pelvis velocity at the start of each step, and the mean magnitude of peroneus longus muscle activity during the single support stance phase of this step, accounting for pelvis displacement.
Push-off stabilization strategy (mechanics)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the time integral of the total ground reaction force under the trail leg during the double support phase preceding this step, accounting for pelvis velocity.
Push-off stabilization strategy (medial gastrocnemius activity)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of medial gastrocnemius activity during the double support phase preceding this step, accounting for pelvis velocity.
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)
We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)
We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Full Information
NCT ID
NCT04855032
First Posted
April 17, 2021
Last Updated
March 14, 2023
Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04855032
Brief Title
Post-stroke Perturbation Training
Official Title
Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reactive Perturbations
Arm Type
Experimental
Arm Title
Proactive Perturbations
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Reactive Perturbations
Intervention Description
A novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered.
Intervention Type
Behavioral
Intervention Name(s)
Proactive Perturbations
Intervention Description
A novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device.
Primary Outcome Measure Information:
Title
Fall incidence
Description
A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.
Time Frame
32 weeks (12-week period pre-intervention; 12-week period post-intervention)
Secondary Outcome Measure Information:
Title
Fear of falling
Description
Participants will be asked if they have a fear of falling (yes/no).
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Functional Gait Assessment
Description
A common clinical measure of gait balance
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Activities-specific Balance Confidence scale
Description
A common clinical measure of balance self-efficacy
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Walking speed
Description
Participants will be instructed to walk overground along a 10-meter path at the speed they would normally use around their house of the store. Speed will be measured for the middle 6-meters of the path.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Foot placement stabilization strategy (mechanics)
Description
We will calculate the partial correlation between the pelvis displacement at the start of each step, and step width at the end of the step, accounting for pelvis velocity.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Foot placement stabilization strategy (gluteus medius activity)
Description
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of gluteus medius activity during the first half of the swing phase, accounting for pelvis velocity.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Center of pressure shift stabilization strategy (mechanics)
Description
We will calculate the partial correlation between the pelvis velocity at the start of each step, and the magnitude of the change in mediolateral center of pressure location under the stance foot during the step, accounting for pelvis displacement.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Center of pressure shift stabilization strategy (peroneus longus activity)
Description
We will calculate the partial correlation between the pelvis velocity at the start of each step, and the mean magnitude of peroneus longus muscle activity during the single support stance phase of this step, accounting for pelvis displacement.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Push-off stabilization strategy (mechanics)
Description
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the time integral of the total ground reaction force under the trail leg during the double support phase preceding this step, accounting for pelvis velocity.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Push-off stabilization strategy (medial gastrocnemius activity)
Description
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of medial gastrocnemius activity during the double support phase preceding this step, accounting for pelvis velocity.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)
Description
We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)
Description
We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
Description
We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Time Frame
8 weeks (pre-intervention; post-intervention)
Title
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
Description
We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Time Frame
8 weeks (pre-intervention; post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experience of a stroke at least 6 months prior to participation
Self-reported experience of a fall in the previous year, and/or a fear of falling
Gait speed of at least 0.2 m/s
Ability to walk on a treadmill without a cane or walker
Provision of informed consent
Exclusion Criteria:
Evidence of cerebellar damage
Resting blood pressure higher than 220/110 mm Hg
History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
Preexisting neurological disorders or dementia
Legal blindness or severe visual impairment
History of DVT or pulmonary embolism within 6 months
Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camden Jacobs
Phone
8437929013
Email
jacobsca@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Dean
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camden Jacobs
Phone
843-792-9013
Email
jacobsca@musc.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data consisting of the clinical assessments and biomechanical walking data collected in this study will be shared through the IPCSR website.
IPD Sharing Time Frame
The data will be shared once the primary publication generated from this study has been published.
IPD Sharing Access Criteria
No restrictions will be placed on the use of the data to be shared.
Learn more about this trial
Post-stroke Perturbation Training
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