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NCT Number: NCT07831642

Vibrotactile Feedback to Improve Walking After 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrotactile feedback system

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Margo Donlin, PhD

CONTACT

[email protected]

(570) 577-1373

Ryan Roza, MD

CONTACT

[email protected]

570-271-6700

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Bucknell University

Registry information

Official study title

Use of Vibrotactile Feedback to Increase Propulsion in Individuals With Chronic Stroke

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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