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Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.
The objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. The sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. The central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of foot placement, an important gait stabilization strategy. This clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. Specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during ~30 minutes of treadmill walking. Participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. Changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensory augmentation | Experimental | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. |
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| Random vibration | Active Comparator | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory Augmentation | Behavioral | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Related or Serious Adverse Events | The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary. | Cumulative over the course of the 4-week intervention |
| Number of Training Sessions Attended | The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8). | Cumulative over the course of the 4-week intervention |
| Intervention Feasibility (Drop-out) | The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session. | 4-weeks |
| Change in Mechanics-dependent Adjustment of Paretic Foot Placement | The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from the initial (Week 0) assessment session to the final (Week 4) assessment session. | 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility (Walking Time) | The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes). | Cumulative over the course of the 4-week intervention |
| Change in Fear of Falling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse C. Dean, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5703 | United States |
De-identified participant data from the assessment sessions (Week 0 and Week 4) will be shared. Specifically, this will include gait biomechanics data (e.g. the partial correlation between mediolateral foot placement and mediolateral pelvis displacement), Functional Gait Assessment scores, Activity-specific Balance Confidence scores, overground gait speeds, and self-reported fear of falling.
Data will be shared 1-month following publication of summary data, and will be shared in perpetuity.
No criteria are anticipated to restrict who de-identified data will be shared with.
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Participants completed an initial assessment session prior to their assignment to a study arm/group. No qualified participants were enrolled into the study, but then excluded from the study before group assignment.
Participants were recruited and enrolled into this study between April of 2022 and March of 2023. All participants were recruited from the RESTORE database at the Medical University of South Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensory Augmentation | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. |
| FG001 | Random Vibration | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Information is presented for all participants who enrolled in this intervention study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensory Augmentation | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Related or Serious Adverse Events | The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary. | Analysis was performed on all participants who began the intervention. | Posted | Count of Participants | Participants | Cumulative over the course of the 4-week intervention |
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Adverse event data were collected over the period spanning from the participant's initial assessment session through their final assessment session. This duration was approximately 5 weeks (initial assessment session; 4 weeks of training; final assessment session).
The investigators followed the Clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sensory Augmentation | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment | One participant experienced a stroke while enrolled in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse Dean | Ralph H. Johnson VA | 8437929566 | deaje@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2020 | Jan 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2021 | Aug 14, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants will be randomly assigned to either an Experimental (n=22) or Control (n=22) group. These groups will differ only in terms of how vibration is delivered to the hip musculature during training sessions. In the Experimental group, vibration magnitude will be controlled by the real-time mechanical state of the user's body. In the Control group, vibration magnitude will be randomly varied.
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| Random Vibration | Behavioral | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. |
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The investigators will assess the change in fear of falling (identified using a yes/no question of "do you have a fear of falling?") from the initial (Week 0) assessment session to the final (Week 4) assessment session.
| 4-weeks |
| Change in Functional Gait Assessment Score | The investigators will quantify the change in Functional Gait Assessment score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 30, and higher scores indicate a better outcome. | 4-weeks |
| Change in Activity-specific Balance Confidence Score | The investigators will quantify the change in Activity-specific Balance Confidence score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. | 4-weeks |
| Change in Overground Self-selected Gait Speed | The investigators will quantify the change in overground self-selected gait speed from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. | 4-weeks |
| Lost to Follow-up |
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| BG001 | Random Vibration | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Mechanics-dependent Adjustment of Paretic Foot Placement | This measure is calculated as the partial correlation between mediolateral pelvis displacement at the start of a paretic step and mediolateral foot placement at the end of the paretic step, accounting for mediolateral velocity of the pelvis. This biomechanical measure of an important gait balance strategy is calculated using data collected from motion capture during treadmill walking. | Mean | Standard Deviation | Unitless (correlation coefficient) |
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| Mechanics-dependent adjustment of Non-paretic Foot Placement | This measure is calculated as the partial correlation between mediolateral pelvis displacement at the start of a non-paretic step and mediolateral foot placement at the end of the non-paretic step, accounting for mediolateral velocity of the pelvis. This biomechanical measure of an important gait balance strategy is calculated using data collected from motion capture during treadmill walking. | Mean | Standard Deviation | Unitless (correlation coefficient) |
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| Fear of Falling | Count of Participants | Participants |
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| Functional Gait Assessment score | The minimum value is 0, the maximum value is 30, and higher scores indicate a better outcome. | Mean | Standard Deviation | units on a scale |
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| Activities-specific Balance Confidence scale score | The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. | Mean | Standard Deviation | units on a scale |
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| Self-selected overground walking speed | Mean | Standard Deviation | meter per second |
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| OG001 | Random Vibration | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. |
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| Primary | Number of Training Sessions Attended | The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8). | Data was analyzed for all participants who completed the final assessment session. | Posted | Median | Full Range | Visits attended | Cumulative over the course of the 4-week intervention |
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| Primary | Intervention Feasibility (Drop-out) | The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session. | Data from all participants enrolled in this study was analyzed. | Posted | Count of Participants | Participants | 4-weeks |
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| Primary | Change in Mechanics-dependent Adjustment of Paretic Foot Placement | The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from the initial (Week 0) assessment session to the final (Week 4) assessment session. | Analyses included participants who completed the final assessment session. | Posted | Mean | 95% Confidence Interval | Unitless (correlation coefficient) | 4-weeks |
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| Secondary | Intervention Feasibility (Walking Time) | The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes). | Data was analyzed for all participants who completed the final assessment session. | Posted | Median | Full Range | Minutes of walking | Cumulative over the course of the 4-week intervention |
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| Secondary | Change in Fear of Falling | The investigators will assess the change in fear of falling (identified using a yes/no question of "do you have a fear of falling?") from the initial (Week 0) assessment session to the final (Week 4) assessment session. | Analysis was performed for all participants who completed the final assessment session. | Posted | Count of Participants | Participants | 4-weeks |
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| Secondary | Change in Functional Gait Assessment Score | The investigators will quantify the change in Functional Gait Assessment score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 30, and higher scores indicate a better outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | 4-weeks |
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| Secondary | Change in Activity-specific Balance Confidence Score | The investigators will quantify the change in Activity-specific Balance Confidence score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. | Data was analyzed for participants who completed the final assessment session. | Posted | Mean | 95% Confidence Interval | score on a scale | 4-weeks |
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| Secondary | Change in Overground Self-selected Gait Speed | The investigators will quantify the change in overground self-selected gait speed from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. | Data was analyzed for participants who completed the final assessment session. | Posted | Mean | 95% Confidence Interval | meters per second | 4-weeks |
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| Post-Hoc | Change in Mechanics-dependent Adjustment of Non-paretic Foot Placement | This not pre-planned effectiveness measure is the change in participant's gait stabilization over the course of the 4-week intervention for steps taken with the non-paretic leg. This was quantified as the partial correlation between non-paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The change in this metric was calculated from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score was subtracted from the final score. | Analyses included participants who completed the final assessment session. | Posted | Mean | 95% Confidence Interval | Unitless (correlation coefficient) | 4-weeks |
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| 0 |
| 22 |
| 1 |
| 22 |
| 0 |
| 22 |
| EG001 | Random Vibration | Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |