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Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop (tDCS)

11. maj 2026 opdateret af: Saint Joseph's University, Philadelphia

Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop: A Case Series

This study aims to determine if combining the treatments of transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) will better help persons with stroke who have difficulty lifting their toes. As part of the treatment, subjects will receive electrical stimulation through pads on their scalp (similar to what one may have received in physical therapy previously to an arm or leg). This protocol is called transcranial direct current stimulation (tDCS). Subjects will also receive electrical stimulation through pads on their leg. This is called functional electrical stimulation (FES). During treatment sessions, subjects will also perform leg activity/strengthening exercises. The aim is to evaluate whether combining FES and tDCS within a PT session would reduce foot drop as indicated by improvements in the amount of toe clearance and ankle motion persons with stroke.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

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

  • Navn: Sylvester Carter, PhD
  • Telefonnummer: 215 596 7087
  • E-mail: scarter1@sju.edu

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Rekruttering
        • Saint Joseph's University

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria: To participate, you must be:

  • 18 years or older
  • Have had 1 or more strokes (> 6 months) affecting ankle dorsiflexion.
  • Discharged from all rehabilitative services.
  • Can walk independently with/without using an assistive device such as a cane without an ankle-foot orthosis (AFO) for 15 minutes.

Exclusion Criteria: You must not have:

  • An inability to repeat and understand 2-step commands.
  • Peripheral neuropathy
  • Damage to the skull or scalp, such as a fracture History of seizures or epilepsy Extremely high or low blood pressure or heart rate Chest pain or shortness of breath when you are resting Botox injections to your leg or foot in the last 4 months

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FES and tDCS

The tDCS was applied as a bilateral montage with the anode of the tDCS device (ActivaDose II, ActivaTek Inc., Salt Lake City, Utah, USA) applied to the involved hemisphere and the cathode over the unaffected hemisphere. The dosage of the tDCS device was one mA for 60 minutes for the duration of the gait training delivered via a pair of sponge electrodes moistened with 0.9% NaCl solution. The exact locations for the electrode placements were based on a 20-point electrode system, in which we chose two points that targeted the motor cortex region corresponding to the left lower limb. Treatments were performed twice weekly over the 8 weeks.

The FES was administered to the tibialis anterior muscle of the impaired lower extremity with one electrode over the common peroneal nerve at the head of the fibula and the other over a motor point in the middle of the muscle belly of the tibialis anterior muscle.
Adfærdsmæssigt: Standard protocol for combo of FES and tDCS
The gait training consisted of treadmill training with forward and backward ambulation with speed progression as appropriate, ambulation over obstacles, ramp ambulation forwards and backwards, and stair ambulation up and down. In each condition, cues were to increase toe clearance on the affected limb and achieve heel strike at initial contact. Vitals were collected at the start and end of each session, and heart rate was measured at the end of each activity, along with the Rating of Perceived Exertion (RPE), to determine whether the participant was working at a higher intensity than baseline.
Aktiv komparator: FES with tDCS subthreshold

The tDCS was applied as a bilateral montage with the anode of the tDCS device (ActivaDose II, ActivaTek Inc., Salt Lake City, UT, USA) applied to the involved hemisphere and the cathode over the unaffected hemisphere. The dosage of the tDCS device was set initially at one mA for 60 minutes and then for the duration of the gait training the machine was turned to subthreshold levels, delivered via a pair of sponge electrodes moistened with 0.9% NaCl solution. The exact locations for the electrode placements were based on a 20-point electrode system, in which we chose two points that targeted the motor cortex region corresponding to the left lower limb. Treatments were performed twice weekly over the 8 weeks.

The FES was administered to the tibialis anterior muscle of the impaired lower extremity with one electrode over the common peroneal nerve at the head of the fibula and the other over a motor point in the middle of the muscle belly of the tibialis anterior muscle.
Adfærdsmæssigt: Standard protocol for combo of FES and tDCS
The gait training consisted of treadmill training with forward and backward ambulation with speed progression as appropriate, ambulation over obstacles, ramp ambulation forwards and backwards, and stair ambulation up and down. In each condition, cues were to increase toe clearance on the affected limb and achieve heel strike at initial contact. Vitals were collected at the start and end of each session, and heart rate was measured at the end of each activity, along with the Rating of Perceived Exertion (RPE), to determine whether the participant was working at a higher intensity than baseline.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
minimum toe clearance
Tidsramme: A pretest at baseline 2-3 days prior to the start of the intervention and then after 12 training sessions (between 6 and 8 weeks) posttests will occur 2-3 days after the 12th and final intervention is completed.
For the motion capture, participants were fitted with a modified Cleveland Clinic marker set where 4 clusters of 4 markers were attached to the thighs and shanks, and wand-mounted markers were also attached bilaterally to the anterior superior iliac spines (ASIS) and the sacrum. Additionally, seven 14 mm reflective markers were attached to the shoe at the upper ridge of the posterior surface of the calcaneus, sustentaculum tali, and lateral aspect of the calcaneus (peroneal tubercle); the heads of the first, second, and fifth metatarsals (MET); and the tip of the shoe/second digit if barefooted. Scores will vary by participant, and the key finding is the change in score from pre- to post-testing, indicating whether or not the intervention effected this change. Minimum value is 10 mm, max value is 40 mm, with a higher score indicating better and safer clearance.
A pretest at baseline 2-3 days prior to the start of the intervention and then after 12 training sessions (between 6 and 8 weeks) posttests will occur 2-3 days after the 12th and final intervention is completed.
Gait speed
Tidsramme: A pretest at baseline 2-3 days prior to the start of the intervention and then a posttest 2-3 days after the 12th and final intervention is completed, 6-8 weeks after the start of the intervention.
time for participants to traverse 10 meters. It is expected that post-training a lower score will be recorded, indicating faster walking and improved speed as a result of the intervention.
A pretest at baseline 2-3 days prior to the start of the intervention and then a posttest 2-3 days after the 12th and final intervention is completed, 6-8 weeks after the start of the intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional gait Assessment
Tidsramme: A pretest at baseline 2-3 days prior to the start of the intervention and then a posttest 2-3 days after the 12th intervention session is completed, 6-8 weeks after the start of the intervention.
a series of walking and balancing tests that require walking 6 meters several times, performing different tasks. A higher score is expected post training, indicating fewer concerns with falling.
A pretest at baseline 2-3 days prior to the start of the intervention and then a posttest 2-3 days after the 12th intervention session is completed, 6-8 weeks after the start of the intervention.
Activities Specific Balance Scale (ABC)
Tidsramme: A pretest at baseline 2-3 days prior to the start of the intervention and then a posttest 2-3 days after the 12th and final intervention session is completed, 6-8 weeks after the training began.
Participants' perceived ability to safely perform a series of activities was rated on a percent scale. This indicator will vary, as sometimes prior to training, individuals are unaware of the concerns of falling, and then sometimes post-training, one is more cautious, and it can be vice versa as well. Thus, the goal is to look for patterns of change.
A pretest at baseline 2-3 days prior to the start of the intervention and then a posttest 2-3 days after the 12th and final intervention session is completed, 6-8 weeks after the training began.

Samarbejdspartnere og efterforskere

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

Sponsor

Saint Joseph's University, Philadelphia

Efterforskere

  • Ledende efterforsker: Gregory Thielman, EdD, Saint Joseph's 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.

Generelle publikationer

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. juni 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

30. august 2029

Datoer for studieregistrering

Først indsendt

26. marts 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • StJosephsU

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