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

11 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Sylvester Carter, PhD
  • Numero di telefono: 215 596 7087
  • Email: scarter1@sju.edu

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Reclutamento
        • Saint Joseph's University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
minimum toe clearance
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional gait Assessment
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Saint Joseph's University, Philadelphia

Investigatori

  • Investigatore principale: Gregory Thielman, EdD, Saint Joseph's University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

30 agosto 2029

Date di iscrizione allo studio

Primo inviato

26 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • StJosephsU

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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