Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop

Official title

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

Overview

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.

Interventions

• Behavioral 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 E

Primary outcome measures

• minimum toe clearance [Time frame: 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 frame: 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 outcome measures (2)

• Functional gait Assessment [Time frame: 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) [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Saint Joseph's University — Philadelphia

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. PMID 11231681
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07592221 · StJosephsU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗