Brain Stimulation + Gait Training for Stroke Recovery
Recruiting in Palo Alto (17 mi)
Overseen bySangeetha Madhavan
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Must not be taking: Anti-spasticity, Seizure threshold
Disqualifiers: Osteoporosis, Cardiorespiratory diseases, Cognitive impairment, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on uncontrolled anti-spasticity medications or medications that could increase motor excitability and lower seizure threshold.
What data supports the effectiveness of this treatment for stroke recovery?
Research shows that high-intensity speed-based treadmill training (HISTT) can significantly improve walking speed and endurance in stroke survivors, with benefits lasting up to three months. This suggests that incorporating high-intensity interval training into stroke rehabilitation may enhance recovery of walking abilities.
12345Is high-intensity treadmill training safe for stroke recovery?
High-intensity treadmill training for stroke recovery appears to be generally safe, with studies reporting no serious adverse events during training sessions. Some nonserious adverse events occurred in a small percentage of sessions, but overall, the training was feasible and contributed positively to physical activity levels.
12346How is the treatment High Intensity Interval Speed Based Treadmill Training (HIISTT) unique for stroke recovery?
High Intensity Interval Speed Based Treadmill Training (HIISTT) is unique because it uses an interval training approach to progressively increase treadmill speed, which is based on principles of sport physiology. This method aims to enhance walking speed and gait recovery in stroke patients, offering a more structured and intensive approach compared to conventional gait training.
178910Eligibility Criteria
This trial is for adults who've had their first stroke more than 3 months ago, can walk at least 5 minutes with or without a walking aid but slower than 1.2 m/s, and have some movement in the affected leg. They shouldn't have severe muscle stiffness, major heart or lung diseases, certain mental impairments, skin conditions worsened by stimulation, metal head implants, pacemakers, recent concussions or be pregnant.Inclusion Criteria
I am older than 18 years.
I had a stroke affecting one side of my brain over 3 months ago.
I walk slower than 1.2 meters per second.
+4 more
Exclusion Criteria
You have very tight muscles in your ankles, which makes it hard to move them.
My cancer has spread to my brainstem or cerebellum.
I am not taking any uncontrolled anti-spasticity medications.
+19 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive cortical priming using brain stimulation and high intensity interval speed based treadmill training
8-12 weeks
Weekly in-person sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
2 visits (in-person)
Participant Groups
The study tests if brain stimulation combined with ankle exercises and high-speed treadmill training improves walking after a stroke. It also looks into how the brain changes with this treatment. Participants will receive transcranial direct current stimulation (tDCS) alongside physical therapy interventions.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Priming+HIISTTExperimental Treatment3 Interventions
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
Group II: Sham+HIISTTPlacebo Group1 Intervention
Sham tDCS before high intensity interval speed based treadmill training
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Physical TherapyChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
University of Maryland, College ParkCollaborator
Northwestern UniversityCollaborator
References
Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. [2019]A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training. This study compares the effects of structured speed-dependent treadmill training (STT) (with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology) with limited progressive treadmill training (LTT) and conventional gait training (CGT) on clinical outcome measures for patients with hemiparesis.
Locomotor training intensity after stroke: Effects of interval type and mode. [2021]Background and Objectives: High-intensity interval training (HIIT) is a promising strategy for improving gait and fitness after stroke, but optimal parameters remain unknown. We tested the effects of short vs long interval type and over-ground vs treadmill mode on training intensity. Methods: Using a repeated measures design, 10 participants with chronic hemiparesis performed 12 HIIT sessions over 4 weeks, alternating between short and long-interval HIIT sessions. Both protocols included 10 minutes of over-ground HIIT, 20 minutes of treadmill HIIT and another 10 minutes over-ground. Short-interval HIIT involved 30 second bursts at maximum safe speed and 30-60 second rest periods. Long-interval HIIT involved 4-minute bursts at ~90% of peak heart rate (HRpeak) and 3-minute recovery periods at ~70% HRpeak. Results: Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HRpeak) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HRpeak) and session step counts (1481 vs 1672). For short-interval HIIT, training speeds and HR were significantly higher on the treadmill vs. overground. For long-interval HIIT, the treadmill elicited HR similar to overground training at significantly slower speeds. Conclusions: Both short and long-interval HIIT elicit high intensities but emphasize different dosing parameters. From these preliminary findings and previous studies, we hypothesize that overground and treadmill short-interval HIIT could be optimal for improving gait speed and overground long-interval HIIT could be optimal for improving gait endurance.
Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]To investigate the feasibility and the effects on gait of a high intensity task-oriented training, incorporating a high cardiovascular workload and large number of repetitions, in patients with subacute stroke, when compared to a low intensity physiotherapy-programme.
Effects of high intensity speed-based treadmill training on ambulatory function in people with chronic stroke: A preliminary study with long-term follow-up. [2020]High intensity treadmill training has shown to be beneficial for stroke survivors, yet the feasibility and long-term effects remain unclear. In this study, we aimed to determine whether a 4-week high intensity speed-based treadmill training (HISTT) is feasible for chronic stroke survivors, and we examined its effects on ambulatory function, and long-term retention. Sixteen individuals post-stroke participated in 40 minutes of HISTT for four weeks at a frequency of three sessions per week. Gait speed was measured using the 10-meter walk test, endurance was measured using the 6-minute walk test, and quality of life was assessed using the Stroke Impact Scale (SIS) at baseline, post-training, and at 3-month follow-up. All participants successfully completed the training without any serious adverse events. Participants significantly increased fastest walking speed by 19%, self-selected walking speed by 18%, and walking endurance by 12% after the training. These improvements were maintained for 3 months after the intervention. Our results indicate that this modified speed-based high intensity walking program has the potential to be a feasible and effective method of gait training for stroke survivors. However, the small sample size and lack of a control group warrant caution in interpretation of results. Further studies are recommended to better understand effectiveness of this protocol in combination with other physical therapy interventions for functional recovery after stroke.
Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. [2022]Improvement in overground walking speed reduces dependency and is a central focus in post-stroke rehabilitation. Previous studies have shown that high-intensity interval training (HIT) can significantly improve functional and health-related outcomes in neurologically health individuals more so than traditional approaches. Emerging evidence suggests the same may be true post-stroke.
Intensive treadmill training in the acute phase after ischemic stroke. [2018]The aim of the study was to (a) assess the feasibility of intensive treadmill training in patients with acute ischemic stroke, (b) test whether physical activity of the legs during training increases with time, and (c) evaluate to what extent training sessions contribute toward the overall physical activity of these patients. Twenty hospitalized patients with acute ischemic stroke trained on a treadmill twice daily for 30 min for 5 days and on day 30. Physical activity was measured as activity counts (AC) from accelerometers. A total of 196 of 224 initiated training sessions were completed. Training started 41.5±14 h after symptom onset. Only nonserious adverse events occurred in 14.7% of the sessions. An intensity of at least 50% of the individual heart rate reserve was obtained in 31% of training sessions. There was a significant increase in AC/min in the legs during training sessions with increasing number of days, with the median AC being 133% higher on day 5 than on day 1. AC in the paretic leg during 60 min of training constituted median 53% of the daytime AC. Early intensive treadmill training in acute ischemic stroke patients is thus feasible and contributes considerably toward the patients' overall physical activity.
Feasibility of challenging treadmill speed-dependent gait and perturbation-induced balance training in chronic stroke patients with low ambulation ability: a randomized controlled trial. [2023]Treadmill training shows advantages in the specificity, amount, and intensity of gait and balance practice for the rehabilitation of stroke patients.
Comparison between treadmill training with rhythmic auditory stimulation and ground walking with rhythmic auditory stimulation on gait ability in chronic stroke patients: A pilot study. [2018]Generally, treadmill training is very effective intervention, and rhythmic auditory stimulation is designed to feedback during gait training in stroke patients.
Randomized Controlled Trial of Robot-Assisted Gait Training versus Therapist-Assisted Treadmill Gait Training as Add-on Therapy in Early Subacute Stroke Patients: The GAITFAST Study Protocol. [2022]The GAITFAST study (gait recovery in patients after acute ischemic stroke) aims to compare the effects of treadmill-based robot-assisted gait training (RTGT) and therapist-assisted treadmill gait training (TTGT) added to conventional physical therapy in first-ever ischemic stroke patients. GAITFAST (Clinicaltrials.gov identifier: NCT04824482) was designed as a single-blind single-center prospective randomized clinical trial with two parallel groups and a primary endpoint of gait speed recovery up to 6 months after ischemic stroke. A total of 120 eligible and enrolled participants will be randomly allocated (1:1) in TTGT or RTGT. All enrolled patients will undergo a 2-week intensive inpatient rehabilitation including TTGT or RTGT followed by four clinical assessments (at the beginning of inpatient rehabilitation 8-15 days after stroke onset, after 2 weeks, and 3 and 6 months after the first assessment). Every clinical assessment will include the assessment of gait speed and walking dependency, fMRI activation measures, neurological and sensorimotor impairments, and gait biomechanics. In a random selection (1:2) of the 120 enrolled patients, multimodal magnetic resonance imaging (MRI) data will be acquired and analyzed. This study will provide insight into the mechanisms behind poststroke gait behavioral changes resulting from intensive rehabilitation including assisted gait training (RTGT or TTGT) in early subacute IS patients.
Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. [2020]Functional electrical stimulation (FES) plus body weight-supported treadmill training (BWSTT) provide effective gait training for poststroke patients with abnormal gait. These features promote a successful active motor relearning of ambulation in stroke survivors.