ClinicalTrials.gg
Not yet recruitingNCT07831642Updated Sep 21, 2026

Vibrotactile Feedback to Improve Walking After Stroke

An interventional study of Vibrotactile Feedback System in Stroke and Hemiparesis, sponsored by Geisinger Clinic. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Geisinger Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Stroke
  • Hemiparesis

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Keywords

  • Stroke
  • Hemiparesis
  • Vibrotactile Feedback
  • Biofeedback
  • Gait Rehabilitation
  • Walking Speed
  • Propulsion
  • Trailing Limb Angle
  • Trunk Sway
  • Stroke Rehabilitation
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In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 32 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Geisinger Clinic is the lead sponsor of 127 studies on the registry; 17 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 85 years
  • Willing and able to provide
  • 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

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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • 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.

    Device: Vibrotactile Feedback System

Interventions

  • DeviceVibrotactile Feedback System

    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.

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What researchers measure

Primary outcomes

  1. Walking Speed

    Walking speed measured during walking trials using timing gates and compared between baseline and vibrotactile feedback conditions.

    Time frame: Single study visit (Day 1)

Secondary outcomes

  1. Forward Propulsion

    Maximum anterior ground reaction force measured during walking trials using force plate data and compared between baseline and vibrotactile feedback conditions.

    Time frame: Single study visit (Day 1)

  2. 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.

    Time frame: Single study visit (Day 1)

  3. 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.

    Time frame: Single study visit (Day 1)

  4. Gait Symmetry

    Symmetry ratio calculated between limbs for trailing limb angle, ankle plantarflexion angle, and forward propulsion during walking trials.

    Time frame: Single study visit (Day 1)

  5. 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.

    Time frame: Single study visit (Day 1)

  6. 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.

    Time frame: Single study visit (Day 1)

  7. 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

    Time frame: Single study visit (Day 1)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Donlin MC. Haptic Feedback Increases Plantarflexion and Propulsion. J Biomech Eng. 2026 Jan 1;148(1):011005. doi: 10.1115/1.4070499. PubMed 41294210 ↗
  • 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. PubMed 25898145 ↗
  • 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. PubMed 33859607 ↗
  • 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. PubMed 29457532 ↗

Individual participant data

Plan to share: Yes — Deidentified individual participant data that underlie the results reported in publications may be shared with qualified researchers for future research purposes.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning after publication of the primary study results and continuing for up to six years following study completion.

Access criteria: Access may be provided to qualified researchers for IRB-approved secondary analyses. Only deidentified data will be shared.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07831642
Lead sponsor
Geisinger Clinic
Collaborators
Bucknell University
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Ryan Roza, MD
Contact
rjroza@geisinger.edu
570-271-6700
Margo Donlin, PhD
Contact
mcd033@bucknell.edu
(570) 577-1373
Ryan Roza, MD
principal investigator · Geisinger Clinic
Margo Donlin, PhD
study director · Bucknell University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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