StrokeNCT07831642
Vibrotactile Feedback to Improve Walking After Stroke
A study testing Vibrotactile Feedback System in people with Stroke and Hemiparesis, run by Geisinger Clinic.
Trial summary
Stroke survivors often walk more slowly and may have difficulty producing the movements needed to walk efficiently. This study will evaluate whether vibrotactile feedback, delivered through small wearable devices that provide vibrations during walking, can help individuals with chronic stroke change specific walking… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Vibrotactile Feedback System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years
- Willing and able to provide informed consent
- Single unilateral stroke at least 6 months prior to enrollment
- ICD diagnosis code for hemiparesis (I69.35X)
- Independently ambulatory (cane acceptable; orthosis may require further evaluation)
- Resting heart rate 40 to 100 beats per minute
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- Resting blood pressure 90/60 to 170/90 mmHg
- Active hip extension of at least 5 degrees
- Active ankle dorsiflexion to neutral with the knee extended
Who cannot join
- Evidence of cerebellar stroke
- Other neurological conditions
- Lower-limb botulinum toxin injections within the previous 4 months
- Pain that limits walking
- Unable to communicate with investigators
- Signs of unilateral neglect
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- Unexplained dizziness within the previous 6 months
- Fall within the previous 6 months
- Congestive heart failure
- Chronic obstructive pulmonary disease
- Severe peripheral vascular disease
- Score greater than 1 on question 1b of the NIH Stroke Scale
- Score greater than 0 on question 1c of the NIH Stroke Scale
- Currently pregnant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of Vibrotactile Feedback to Increase Propulsion in Individuals With Chronic Stroke
Stroke survivors often walk more slowly and may have difficulty producing the movements needed to walk efficiently. This study will evaluate whether vibrotactile feedback, delivered through small wearable devices that provide vibrations during walking, can help individuals with chronic stroke change specific walking movements related to walking speed, propulsion, and balance.
Participants will complete a single study visit at Bucknell University. During the visit, participants will perform several walking trials with and without vibrotactile feedback and will complete common clinical mobility and balance assessments. Motion capture technology and wearable sensors will be used to measure movement during walking.
The goal of this study is to better understand how vibrotactile feedback can be used to improve walking performance after stroke and to support the future development of rehabilitation approaches for stroke survivors.
Read the detailed description
Post-stroke gait rehabilitation frequently targets walking speed because improved walking speed is associated with greater functional mobility and community participation. Forward propulsion is strongly related to walking speed, but the biomechanical concepts commonly targeted in rehabilitation can be difficult for patients to understand and apply during walking. Vibrotactile biofeedback may provide a simple and intuitive method of promoting desirable gait modifications by delivering real-time feedback based on clinically meaningful movement parameters.
The purpose of this study is to evaluate the immediate effects of vibrotactile feedback on walking biomechanics in individuals with chronic stroke. Specifically, the study will investigate whether vibrotactile feedback can increase walking speed and forward propulsion, improve symmetry of gait-related measures, and reduce lateral trunk sway during walking. The study will also explore the use of wearable inertial measurement units (IMUs) to objectively quantify movement during common clinical mobility and balance assessments.
Participants will complete a single study visit at the Bucknell University Biomechanics Laboratory. During the visit, motion capture technology, wearable inertial measurement units, timing gates, and force plates will be used to measure walking biomechanics. Participants will complete walking trials under baseline and vibrotactile feedback conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway. Participants will also complete the Timed Up and Go (TUG) assessment and the Berg Balance Scale (BBS).
The information collected in this study will be used to improve understanding of how vibrotactile feedback can influence gait biomechanics after stroke and may support future development of rehabilitation approaches intended to improve walking function and mobility in stroke survivors.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Vibrotactile Feedback System
- Keywords
- Stroke, Hemiparesis, Vibrotactile Feedback, Biofeedback, Gait Rehabilitation, Walking Speed, Propulsion, Trailing Limb Angle, Trunk Sway, Stroke Rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile Feedback SystemDevice
Participants will receive vibrotactile feedback using a wearable SageMotion system consisting of inertial measurement units mounted on elastic straps. The system calculates joint angles during walking and provides vibration-based feedback when predefined movement goals are achieved. Feedback conditions will target trailing limb angle, ankle plantarflexion, and trunk sway during walking.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Feedback Walking Assessment | Experimental | Participants with chronic stroke will complete a single study visit that includes baseline walking assessment, vibrotactile feedback walking conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway, and clinical mobility and balance assessments. All participants will complete all study conditions and serve as their own controls. Receives: Device: Vibrotactile Feedback System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
Walking speed measured during walking trials using timing gates and compared between baseline and vibrotactile feedback conditions.
Measured: Single study visit (Day 1)
Secondary outcomes (7)
Forward Propulsion
Maximum anterior ground reaction force measured during walking trials using force plate data and compared between baseline and vibrotactile feedback conditions.
Measured: Single study visit (Day 1)
Trailing Limb Angle
Trailing limb angle measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions.
Measured: Single study visit (Day 1)
Ankle Plantarflexion Angle
Peak ankle plantarflexion angle measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions.
Measured: Single study visit (Day 1)
Gait Symmetry
Symmetry ratio calculated between limbs for trailing limb angle, ankle plantarflexion angle, and forward propulsion during walking trials.
Measured: Single study visit (Day 1)
Lateral Trunk Sway
Magnitude of lateral trunk sway measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions.
Measured: Single study visit (Day 1)
Timed Up and Go Assessment
Performance on the Timed Up and Go assessment collected during the study visit and used to explore relationships between clinical mobility measures and wearable sensor measurements.
Measured: Single study visit (Day 1)
Berg Balance Scale Assessment
Performance on the Berg Balance Scale assessment collected during the study visit and used to explore relationships between clinical balance measures and wearable sensor measurements
Measured: Single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete the same study procedures during a single study visit and will serve as their own controls. Participants will complete a baseline walking condition followed by vibrotactile feedback conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway. The order of the feedback conditions will be randomized after completion of the baseline condition to reduce potential fatigue and ordering effects.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Bucknell University
- Responsible party
- Sponsor
- Investigators
- Ryan Roza, MD, Principal investigator, Geisinger ClinicMargo Donlin, PhD, Study director, Bucknell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831642
- Sponsor's protocol ID
- Vibrotactile-Stroke Feedback
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported in publications may be shared with qualified researchers for future research purposes.
Publications
Donlin MC. Haptic Feedback Increases Plantarflexion and Propulsion. J Biomech Eng. 2026 Jan 1;148(1):011005. doi: 10.1115/1.4070499.
PubMed 41294210Hsiao H, Knarr BA, Higginson JS, Binder-Macleod SA. Mechanisms to increase propulsive force for individuals poststroke. J Neuroeng Rehabil. 2015 Apr 18;12:40. doi: 10.1186/s12984-015-0030-8.
PubMed 25898145Spencer J, Wolf SL, Kesar TM. Biofeedback for Post-stroke Gait Retraining: A Review of Current Evidence and Future Research Directions in the Context of Emerging Technologies. Front Neurol. 2021 Mar 30;12:637199. doi: 10.3389/fneur.2021.637199. eCollection 2021.
PubMed 33859607Genthe K, Schenck C, Eicholtz S, Zajac-Cox L, Wolf S, Kesar TM. Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Top Stroke Rehabil. 2018 Apr;25(3):186-193. doi: 10.1080/10749357.2018.1436384. Epub 2018 Feb 19.
PubMed 29457532
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vibrotactile Feedback to Increase Propulsion in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07831642
- Acronym / sponsor ID
- Vibrotactile-Stroke Feedback
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Hemiparesis, Vibrotactile Feedback, Biofeedback, Gait Rehabilitation, Walking Speed, Propulsion, Trailing Limb Angle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Bucknell University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke survivors often walk more slowly and may have difficulty producing the movements needed to walk efficiently. This study will evaluate whether vibrotactile feedback, delivered through small wearable devices that provide vibrations during walking, can help individuals with chronic stroke change specific walking movements related to walking speed, propulsion, and balance.
Participants will complete a single study visit at Bucknell University. During the visit, participants will perform several walking trials with and without vibrotactile feedback and will complete common clinical mobility and balance assessments. Motion capture technology and wearable sensors will be used to measure movement during walking.
The goal of this study is to better understand how vibrotactile feedback can be used to improve walking performance after stroke and to support the future development of rehabilitation approaches for stroke survivors.
Detailed description
Post-stroke gait rehabilitation frequently targets walking speed because improved walking speed is associated with greater functional mobility and community participation. Forward propulsion is strongly related to walking speed, but the biomechanical concepts commonly targeted in rehabilitation can be difficult for patients to understand and apply during walking. Vibrotactile biofeedback may provide a simple and intuitive method of promoting desirable gait modifications by delivering real-time feedback based on clinically meaningful movement parameters.
The purpose of this study is to evaluate the immediate effects of vibrotactile feedback on walking biomechanics in individuals with chronic stroke. Specifically, the study will investigate whether vibrotactile feedback can increase walking speed and forward propulsion, improve symmetry of gait-related measures, and reduce lateral trunk sway during walking. The study will also explore the use of wearable inertial measurement units (IMUs) to objectively quantify movement during common clinical mobility and balance assessments.
Participants will complete a single study visit at the Bucknell University Biomechanics Laboratory. During the visit, motion capture technology, wearable inertial measurement units, timing gates, and force plates will be used to measure walking biomechanics. Participants will complete walking trials under baseline and vibrotactile feedback conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway. Participants will also complete the Timed Up and Go (TUG) assessment and the Berg Balance Scale (BBS).
The information collected in this study will be used to improve understanding of how vibrotactile feedback can influence gait biomechanics after stroke and may support future development of rehabilitation approaches intended to improve walking function and mobility in stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will complete the same study procedures during a single study visit and will serve as their own controls. Participants will complete a baseline walking condition followed by vibrotactile feedback conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway. The order of the feedback conditions will be randomized after completion of the baseline condition to reduce potential fatigue and ordering effects.
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Feedback Walking Assessment | Experimental | Device: Vibrotactile Feedback SystemParticipants with chronic stroke will complete a single study visit that includes baseline walking assessment, vibrotactile feedback walking conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway, and clinical mobility and balance assessments. All participants will complete all study conditions and serve as their own controls. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 85 years
- Willing and able to provide informed consent
- Single unilateral stroke at least 6 months prior to enrollment
- ICD diagnosis code for hemiparesis (I69.35X)
- Independently ambulatory (cane acceptable; orthosis may require further evaluation)
Key exclusion criteria (14 listed)
- Evidence of cerebellar stroke
- Other neurological conditions
- Lower-limb botulinum toxin injections within the previous 4 months
- Pain that limits walking
- Unable to communicate with investigators
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 |
|---|---|---|
| Vibrotactile Feedback SystemParticipants will receive vibrotactile feedback using a wearable SageMotion system consisting of inertial measurement units mounted on elastic straps. The system calculates joint angles during walking and provides vibration-based feedback when predefined movement goals are achieved. Feedback conditions will target trailing limb angle, ankle plantarflexion, and trunk sway during walking. | Device | Vibrotactile Feedback Walking Assessment |
Primary outcome
Walking Speed
Time frame: Single study visit (Day 1)
Walking speed measured during walking trials using timing gates and compared between baseline and vibrotactile feedback conditions.
7 secondary outcomes
Forward Propulsion
Time frame: Single study visit (Day 1)
Trailing Limb Angle
Time frame: Single study visit (Day 1)
Ankle Plantarflexion Angle
Time frame: Single study visit (Day 1)
Gait Symmetry
Time frame: Single study visit (Day 1)
Lateral Trunk Sway
Time frame: Single study visit (Day 1)
Timed Up and Go Assessment
Time frame: Single study visit (Day 1)
Berg Balance Scale Assessment
Time frame: Single study visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 41294210Donlin MC. Haptic Feedback Increases Plantarflexion and Propulsion. J Biomech Eng. 2026 Jan 1;148(1):011005. doi: 10.1115/1.4070499.
- Background: PubMed 25898145Hsiao H, Knarr BA, Higginson JS, Binder-Macleod SA. Mechanisms to increase propulsive force for individuals poststroke. J Neuroeng Rehabil. 2015 Apr 18;12:40. doi: 10.1186/s12984-015-0030-8.
- Background: PubMed 33859607Spencer J, Wolf SL, Kesar TM. Biofeedback for Post-stroke Gait Retraining: A Review of Current Evidence and Future Research Directions in the Context of Emerging Technologies. Front Neurol. 2021 Mar 30;12:637199. doi: 10.3389/fneur.2021.637199. eCollection 2021.
- Background: PubMed 29457532Genthe K, Schenck C, Eicholtz S, Zajac-Cox L, Wolf S, Kesar TM. Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Top Stroke Rehabil. 2018 Apr;25(3):186-193. doi: 10.1080/10749357.2018.1436384. Epub 2018 Feb 19.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in publications may be shared with qualified researchers for future research purposes.
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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.
Ryan Roza, MD principal investigator
Geisinger Clinic
Margo Donlin, PhD study director
Bucknell University
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Feedback System in people with Stroke and Hemiparesis, run by Geisinger Clinic.
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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Roza, MD (570-271-6700, rjroza@geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Single study visit (Day 1)). 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 NCT07831642, which also lists 4 linked publications.
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 21 Sep 2026.