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Vibrotactile Feedback to Improve Walking After Stroke

15. september 2026 opdateret af: Geisinger Clinic

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Walking Speed
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forward Propulsion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Ryan Roza, MD, Geisinger Clinic
  • Studieleder: Margo Donlin, PhD, Bucknell University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

31. maj 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

10. september 2026

Først indsendt, der opfyldte QC-kriterier

15. september 2026

Først opslået (Faktiske)

21. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified individual participant data that underlie the results reported in publications may be shared with qualified researchers for future research purposes.

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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