Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Joseph's University, Philadelphia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Standard protocol for combo of FES and tDCS
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: FES and tDCSExperimental treatment 1 intervention
Group B: FES with tDCS subthresholdActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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 outcomes
1
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.
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.2
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov