Stroke
Conditions
Keywords
stroke, gait
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSensory 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.
BEHAVIORALRandom 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Experience of a stroke 6 months prior to participation * 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 congestive heart failure, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Related or Serious Adverse Events | Cumulative over the course of the 4-week intervention | 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. |
| Number of Training Sessions Attended | Cumulative over the course of the 4-week intervention | The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8). |
| Intervention Feasibility (Drop-out) | 4-weeks | The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session. |
| Change in Mechanics-dependent Adjustment of Paretic Foot Placement | 4-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility (Walking Time) | Cumulative over the course of the 4-week intervention | The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes). |
| Change in Overground Self-selected Gait Speed | 4-weeks | 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. |
| Change in Fear of Falling | 4-weeks | 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. |
| Change in Functional Gait Assessment Score | 4-weeks | 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. |
| Change in Activity-specific Balance Confidence Score | 4-weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Macular degeneration, unrelated to study procedures. | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Random Vibration | Sensory Augmentation |
|---|---|---|---|
| Activities-specific Balance Confidence scale score | 64.6 units on a scale STANDARD_DEVIATION 19.6 | 64.2 units on a scale STANDARD_DEVIATION 19.7 | 65.0 units on a scale STANDARD_DEVIATION 20 |
| Age, Continuous | 60 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 12 | 64 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 21 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fear of Falling | 19 Participants | 11 Participants | 8 Participants |
| Functional Gait Assessment score | 15.25 units on a scale STANDARD_DEVIATION 5.2 | 15.23 units on a scale STANDARD_DEVIATION 4.66 | 15.27 units on a scale STANDARD_DEVIATION 5.81 |
| Mechanics-dependent adjustment of Non-paretic Foot Placement | -.134 Unitless (correlation coefficient) STANDARD_DEVIATION 0.247 | -.075 Unitless (correlation coefficient) STANDARD_DEVIATION 0.254 | -.192 Unitless (correlation coefficient) STANDARD_DEVIATION 0.231 |
| Mechanics-dependent Adjustment of Paretic Foot Placement | -.094 Unitless (correlation coefficient) STANDARD_DEVIATION 0.247 | -.043 Unitless (correlation coefficient) STANDARD_DEVIATION 0.236 | -.145 Unitless (correlation coefficient) STANDARD_DEVIATION 0.253 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 12 Participants | 14 Participants |
| Self-selected overground walking speed | 0.79 meter per second STANDARD_DEVIATION 0.29 | 0.75 meter per second STANDARD_DEVIATION 0.27 | 0.82 meter per second STANDARD_DEVIATION 0.3 |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 32 Participants | 16 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 1 / 22 | 0 / 22 |
Outcome results
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.
Time frame: 4-weeks
Population: Analyses included participants who completed the final assessment session.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensory Augmentation | Change in Mechanics-dependent Adjustment of Paretic Foot Placement | 0.078 Unitless (correlation coefficient) |
| Random Vibration | Change in Mechanics-dependent Adjustment of Paretic Foot Placement | 0.054 Unitless (correlation coefficient) |
p-value: 0.72t-test, 2 sided
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.
Time frame: 4-weeks
Population: Data from all participants enrolled in this study was analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensory Augmentation | Intervention Feasibility (Drop-out) | 2 Participants |
| Random Vibration | Intervention Feasibility (Drop-out) | 1 Participants |
p-value: 1Fisher Exact
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).
Time frame: Cumulative over the course of the 4-week intervention
Population: Data was analyzed for all participants who completed the final assessment session.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sensory Augmentation | Number of Training Sessions Attended | 7 Visits attended |
| Random Vibration | Number of Training Sessions Attended | 8 Visits attended |
p-value: 0.017Wilcoxon (Mann-Whitney)
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.
Time frame: Cumulative over the course of the 4-week intervention
Population: Analysis was performed on all participants who began the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensory Augmentation | Percentage of Participants With Related or Serious Adverse Events | 1 Participants |
| Random Vibration | Percentage of Participants With Related or Serious Adverse Events | 0 Participants |
p-value: 1Fisher Exact
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.
Time frame: 4-weeks
Population: Data was analyzed for participants who completed the final assessment session.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensory Augmentation | Change in Activity-specific Balance Confidence Score | 1.0 score on a scale |
| Random Vibration | Change in Activity-specific Balance Confidence Score | 2.1 score on a scale |
p-value: 0.69t-test, 2 sided
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.
Time frame: 4-weeks
Population: Analysis was performed for all participants who completed the final assessment session.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sensory Augmentation | Change in Fear of Falling | Fear of falling in initial assessment session | 8 Participants |
| Sensory Augmentation | Change in Fear of Falling | Fear of falling in final assessment session | 8 Participants |
| Random Vibration | Change in Fear of Falling | Fear of falling in initial assessment session | 10 Participants |
| Random Vibration | Change in Fear of Falling | Fear of falling in final assessment session | 9 Participants |
p-value: 0.68Wilcoxon (Mann-Whitney)
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.
Time frame: 4-weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensory Augmentation | Change in Functional Gait Assessment Score | 0.8 score on a scale |
| Random Vibration | Change in Functional Gait Assessment Score | 1.7 score on a scale |
p-value: 0.25t-test, 2 sided
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.
Time frame: 4-weeks
Population: Data was analyzed for participants who completed the final assessment session.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensory Augmentation | Change in Overground Self-selected Gait Speed | 0.01 meters per second |
| Random Vibration | Change in Overground Self-selected Gait Speed | 0.05 meters per second |
p-value: 0.2t-test, 2 sided
Secondary
Intervention Feasibility (Walking Time)
The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes).
Time frame: Cumulative over the course of the 4-week intervention
Population: Data was analyzed for all participants who completed the final assessment session.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sensory Augmentation | Intervention Feasibility (Walking Time) | 144 Minutes of walking |
| Random Vibration | Intervention Feasibility (Walking Time) | 255 Minutes of walking |
p-value: 0.001t-test, 2 sided
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.
Time frame: 4-weeks
Population: Analyses included participants who completed the final assessment session.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensory Augmentation | Change in Mechanics-dependent Adjustment of Non-paretic Foot Placement | 0.073 Unitless (correlation coefficient) |
| Random Vibration | Change in Mechanics-dependent Adjustment of Non-paretic Foot Placement | 0.037 Unitless (correlation coefficient) |
p-value: 0.62t-test, 2 sided