Vibrotactile Feedback to Improve Walking After Stroke
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ryan Roza, MD
- Phone Number: 570-271-6700
- Email: rjroza@geisinger.edu
Study Contact Backup
- Name: Margo Donlin, PhD
- Phone Number: (570) 577-1373
- Email: mcd033@bucknell.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vibrotactile Feedback Walking Assessment
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Single study visit (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forward Propulsion
Time Frame: Single study visit (Day 1)
|
Maximum anterior ground reaction force measured during walking trials using force plate data and compared between baseline and vibrotactile feedback conditions. |
Single study visit (Day 1)
|
|
Trailing Limb Angle
Time Frame: Single study visit (Day 1)
|
Trailing limb angle measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions. |
Single study visit (Day 1)
|
|
Ankle Plantarflexion Angle
Time Frame: Single study visit (Day 1)
|
Peak ankle plantarflexion angle measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions. |
Single study visit (Day 1)
|
|
Gait Symmetry
Time Frame: Single study visit (Day 1)
|
Symmetry ratio calculated between limbs for trailing limb angle, ankle plantarflexion angle, and forward propulsion during walking trials. |
Single study visit (Day 1)
|
|
Lateral Trunk Sway
Time Frame: Single study visit (Day 1)
|
Magnitude of lateral trunk sway measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions. |
Single study visit (Day 1)
|
|
Timed Up and Go Assessment
Time Frame: Single study visit (Day 1)
|
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. |
Single study visit (Day 1)
|
|
Berg Balance Scale Assessment
Time Frame: Single study visit (Day 1)
|
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 |
Single study visit (Day 1)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan Roza, MD, Geisinger Clinic
- Study Director: Margo Donlin, PhD, Bucknell University
Publications and helpful links
General Publications
- Genthe 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.
- Spencer 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.
- Donlin MC. Haptic Feedback Increases Plantarflexion and Propulsion. J Biomech Eng. 2026 Jan 1;148(1):011005. doi: 10.1115/1.4070499.
- Hsiao 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vibrotactile-Stroke Feedback
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Deidentified individual participant data that underlie the results reported in publications may be shared with qualified researchers for future research purposes.
IPD Sharing Time Frame
Beginning after publication of the primary study results and continuing for up to six years following study completion.
IPD Sharing Access Criteria
Access may be provided to qualified researchers for IRB-approved secondary analyses. Only deidentified data will be shared.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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