FallstDCSNCT07592221
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
A study testing Standard protocol for combo of FES and tDCS in people with Falls and Foot Drop, run by Saint Joseph's University, Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Falls, Foot Drop, Post Stroke Recovery
- What is being tested?
- Standard protocol for combo of FES and tDCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Saint Joseph's University
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Falls, Foot Drop, Post Stroke Recovery
- Being tested
- Standard protocol for combo of FES and tDCS
- Keywords
- transcranial direct current stimulation, functional electrical stimulation, minimum toe clearance
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard protocol for combo of FES and tDCSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard protocol for combo of FES and tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is initially a single group but will progress to a RCT with subthreshold doses for the control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Joseph's University, Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Thielman, EdD, Principal investigator, Saint Joseph's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592221
- Sponsor's protocol ID
- StJosephsU
- Acronym
- tDCS
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11231681Prudham 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.
PubMed 7270321Hornbrook 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.
PubMed 8150304Hausdorff 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.
PubMed 11494184Campbell 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.
PubMed 2738307Blake 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.
PubMed 3266440Berg 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.
PubMed 9271288Maki 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.
PubMed 9063277Al 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.
PubMed 34639597Nolan 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.
PubMed 21515889O'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.
PubMed 24412265Peishun 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.
PubMed 34853588Tsao 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))