Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop

NCT07592221 | Recruiting DMC

• 1 other identifier: StJosephsU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Falls; Foot Drop; Post Stroke Recovery

Keywords

transcranial direct current stimulation; functional electrical stimulation; minimum toe clearance

Outcome Measures

Primary Outcomes (2)

• minimum toe clearance

  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

  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.

Secondary Outcomes (2)

• Functional gait Assessment

  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)

  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.

Study Arms (2)

FES and tDCS

EXPERIMENTAL

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.

Behavioral: Standard protocol for combo of FES and tDCS

FES with tDCS subthreshold

ACTIVE COMPARATOR

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.

Behavioral: Standard protocol for combo of FES and tDCS

Interventions

Standard protocol for combo of FES and tDCS BEHAVIORAL

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.

FES and tDCS; FES with tDCS subthreshold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Joseph's University, Philadelphia: lead

Study Sites (1)

Saint Joseph's University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (13)

• Sterling DA, O'Connor JA, Bonadies J. Geriatric falls: injury severity is high and disproportionate to mechanism. J Trauma. 2001 Jan;50(1):116-9. doi: 10.1097/00005373-200101000-00021.

  PMID: 11231681 BACKGROUND

• Prudham D, Evans JG. Factors associated with falls in the elderly: a community study. Age Ageing. 1981 Aug;10(3):141-6. doi: 10.1093/ageing/10.3.141.

  PMID: 7270321 BACKGROUND

• Hornbrook MC, Stevens VJ, Wingfield DJ, Hollis JF, Greenlick MR, Ory MG. Preventing falls among community-dwelling older persons: results from a randomized trial. Gerontologist. 1994 Feb;34(1):16-23. doi: 10.1093/geront/34.1.16.

  PMID: 8150304 BACKGROUND

• Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6. doi: 10.1053/apmr.2001.24893.

  PMID: 11494184 BACKGROUND

• Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112.

  PMID: 2738307 BACKGROUND

• Blake AJ, Morgan K, Bendall MJ, Dallosso H, Ebrahim SB, Arie TH, Fentem PH, Bassey EJ. Falls by elderly people at home: prevalence and associated factors. Age Ageing. 1988 Nov;17(6):365-72. doi: 10.1093/ageing/17.6.365.

  PMID: 3266440 BACKGROUND

• Berg WP, Alessio HM, Mills EM, Tong C. Circumstances and consequences of falls in independent community-dwelling older adults. Age Ageing. 1997 Jul;26(4):261-8. doi: 10.1093/ageing/26.4.261.

  PMID: 9271288 BACKGROUND

• Maki BE. Gait changes in older adults: predictors of falls or indicators of fear. J Am Geriatr Soc. 1997 Mar;45(3):313-20. doi: 10.1111/j.1532-5415.1997.tb00946.x.

  PMID: 9063277 BACKGROUND

• Al Bochi A, Delfi G, Dutta T. A Scoping Review on Minimum Foot Clearance: An Exploration of Level-Ground Clearance in Individuals with Abnormal Gait. Int J Environ Res Public Health. 2021 Sep 29;18(19):10289. doi: 10.3390/ijerph181910289.

  PMID: 34639597 BACKGROUND

• Nolan KJ, Yarossi M. Weight transfer analysis in adults with hemiplegia using ankle foot orthosis. Prosthet Orthot Int. 2011 Mar;35(1):45-53. doi: 10.1177/0309364610393061.

  PMID: 21515889 BACKGROUND

• O'Dell MW, Dunning K, Kluding P, Wu SS, Feld J, Ginosian J, McBride K. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM R. 2014 Jul;6(7):587-601; quiz 601. doi: 10.1016/j.pmrj.2014.01.001. Epub 2014 Jan 9.

  PMID: 24412265 BACKGROUND

• Peishun C, Haiwang Z, Taotao L, Hongli G, Yu M, Wanrong Z. Changes in Gait Characteristics of Stroke Patients with Foot Drop after the Combination Treatment of Foot Drop Stimulator and Moving Treadmill Training. Neural Plast. 2021 Nov 22;2021:9480957. doi: 10.1155/2021/9480957. eCollection 2021.

  PMID: 34853588 BACKGROUND

• Tsao Cw Fau - Aday AW, Aday Aw Fau - Almarzooq ZI, Almarzooq Zi Fau - Anderson CAM, et al. Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. (1524-4539 (Electronic))

  BACKGROUND

MeSH Terms

Conditions

Peroneal Neuropathies

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Gregory Thielman, EdD

  Saint Joseph's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Thielman, EdD

CONTACT

8562667863; gthielman@sju.edu

Sylvester Carter, PhD

CONTACT

215 596 7087; scarter1@sju.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is initially a single group but will progress to a RCT with subthreshold doses for the control group

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 30, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)