StrokeEarly Phase 1SAMNCT03988400

Sensory Augmentation Methods in Stroke

A Early Phase 1 study testing Sensory Augmentation and Random Vibration in people with Stroke, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Stroke
What is being tested?: Sensory Augmentation and Random Vibration
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 4 Apr 2022to 26 Apr 2023
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703

Other trials in United States

About this study

Official title: Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability

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.

Read the 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.

Conditions: Stroke
Being tested: Sensory Augmentation, Random Vibration
Keywords: stroke, gait
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sensory AugmentationBehavioural
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.
Random VibrationBehavioural
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.

Study groups in NCT03988400
Study group	Role	What they receive
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. Receives: Behavioral: Sensory Augmentation
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. Receives: Behavioral: Random Vibration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 4-weeks

Secondary outcomes (5)

Intervention Feasibility (Walking Time)
The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes).
Measured: Cumulative over the course of the 4-week intervention
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202226 Apr 2023

First posted17 Jun 2019
Study start4 Apr 2022
Primary completion26 Apr 2023
Study completion26 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03988400
Sponsor's protocol ID: A3146-R
Acronym: SAM
Status last verified: Aug 2024
First submitted: 14 Jun 2019
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability
ClinicalTrials.gov ID: NCT03988400
Acronym / sponsor ID: SAM / A3146-R
Conditions: Stroke
Keywords: stroke, gait
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 4 Apr 2022 (actual)
Primary completion: 26 Apr 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 17 Jun 2019 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Sensory augmentation	Experimental	Behavioral: Sensory AugmentationParticipants 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.
Random vibration	Active comparator	Behavioral: Random VibrationParticipants 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sensory AugmentationParticipants 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.	Behavioural	Sensory augmentation
Random VibrationParticipants 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.	Behavioural	Random vibration

Primary outcome

Percentage of Participants With Related or Serious Adverse Events
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.

5 secondary outcomes

Intervention Feasibility (Walking Time)
Time frame: Cumulative over the course of the 4-week intervention
Change in Fear of Falling
Time frame: 4-weeks
Change in Functional Gait Assessment Score
Time frame: 4-weeks
Change in Activity-specific Balance Confidence Score
Time frame: 4-weeks
Change in Overground Self-selected Gait Speed
Time frame: 4-weeks

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sensory Augmentation	22	20
Random Vibration	22	21

Primary outcome: Percentage of Participants With Related or Serious Adverse Events

Time frame: Cumulative over the course of the 4-week intervention. Count of participants. Unit: Participants

Measure	Sensory Augmentation n = 22	Random Vibration n = 22
Value	1	0

Sensory Augmentation vs Random Vibration: p = 1, Fisher Exact

Population analysed: Analysis was performed on all participants who began the intervention.

Primary outcome: Number of Training Sessions Attended

Time frame: Cumulative over the course of the 4-week intervention. Median (Full Range). Unit: Visits attended

Measure	Sensory Augmentation n = 20	Random Vibration n = 21
Value	7 (3 to 8)	8 (6 to 8)

Sensory Augmentation vs Random Vibration: p = 0.017, Wilcoxon (Mann-Whitney)

Population analysed: Data was analyzed for all participants who completed the final assessment session.

Primary outcome: Intervention Feasibility (Drop-out)

Time frame: 4-weeks. Count of participants. Unit: Participants

Measure	Sensory Augmentation n = 22	Random Vibration n = 22
Value	2	1

Sensory Augmentation vs Random Vibration: p = 1, Fisher Exact

Population analysed: Data from all participants enrolled in this study was analyzed.

Primary outcome: Change in Mechanics-dependent Adjustment of Paretic Foot Placement

Time frame: 4-weeks. Mean (95% Confidence Interval). Unit: Unitless (correlation coefficient)

Measure	Sensory Augmentation n = 20	Random Vibration n = 21
Value	0.078 (0.002 to 0.154)	0.054 (-0.053 to 0.160)

Sensory Augmentation vs Random Vibration: p = 0.72, t-test, 2 sided

Population analysed: Analyses included participants who completed the final assessment session.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sensory Augmentation	1 of 22 (4.5%)	0 of 22 (0%)	0 of 22
Random Vibration	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Stroke

Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jesse C. Dean, PhD principal investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Sensory Augmentation and Random Vibration in people with Stroke, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Related or Serious Adverse Events (time frame: Cumulative over the course of the 4-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03988400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.