Brain Stimulation + Gait Training for Stroke Recovery

Overseen By Sangeetha Madhavan

Age: 18+

Sex: Any

Trial Phase: Academic

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 You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8-12 weeks

100 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{1 7 8 9 10}

Research Team

Sangeetha Madhavan

Principal Investigator

University of Illinois at Chicago

Eligibility 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.

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.

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)

Treatment Details

Interventions

• Ankle motor training
• High intensity interval speed based treadmill training (HIISTT)
• Transcranial direct current stimulation (tDCS)

Trial Overview 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.

Participant Groups

Group I: Priming+HIISTT Experimental Treatment 3 Interventions

Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training

Group II: Sham+HIISTT Placebo Group 1 Intervention

Sham tDCS before high intensity interval speed based treadmill training

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Findings from Research

Structured speed-dependent treadmill training (STT) significantly improved walking speed, cadence, stride length, and Functional Ambulation Category scores in 60 poststroke patients compared to limited progressive treadmill training (LTT) and conventional gait training (CGT) after 4 weeks of treatment.

The results indicate that STT is a more effective rehabilitation strategy for enhancing gait function in stroke patients, suggesting its potential as a dynamic approach to address gait dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Pohl, M., Mehrholz, J., Ritschel, C., et al.[2019]

Short-interval high-intensity interval training (HIIT) resulted in faster walking speeds compared to long-interval HIIT, suggesting it may be more effective for improving gait speed in stroke survivors.

Both short and long-interval HIIT sessions achieved high training intensities, but they may serve different purposes: short-interval HIIT could enhance gait speed, while long-interval HIIT may be better for improving endurance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor training intensity after stroke: Effects of interval type and mode. Boyne, P., Scholl, V., Doren, S., et al.[2021]

A high-intensity task-oriented training program significantly improved gait speed and walking capacity in patients with subacute stroke compared to a low-intensity physiotherapy program, as shown by results from the 10-metre timed walking test and the six-minute walk test.

The study involved 44 stroke patients and demonstrated that while the high-intensity training was feasible and effective for improving gait, it did not show significant differences in balance measures, suggesting that future research should also assess physical fitness and energy expenditure during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Outermans, JC., van Peppen, RP., Wittink, H., et al.[2022]

A 4-week high intensity speed-based treadmill training program was feasible for 16 chronic stroke survivors, with no serious adverse events reported during the training.

Participants showed significant improvements in walking speed (up to 19%) and endurance (up to 12%), and these gains were maintained for 3 months after the training, suggesting the program's effectiveness for gait training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high intensity speed-based treadmill training on ambulatory function in people with chronic stroke: A preliminary study with long-term follow-up. Madhavan, S., Lim, H., Sivaramakrishnan, A., et al.[2020]

A single session of high-intensity interval training (HIT) on a treadmill was found to be feasible for stroke survivors, with participants able to walk at speeds significantly faster than their usual overground walking speed, indicating potential for improved rehabilitation outcomes.

No adverse events occurred during the training, and participants reached heart rates in the vigorous exercise range, suggesting that this HIT approach is safe and could enhance cardiovascular fitness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. Aaron, SE., Gregory, CM.[2022]

Intensive treadmill training is feasible for patients with acute ischemic stroke, with 196 out of 224 training sessions completed and only nonserious adverse events reported in 14.7% of sessions.

The training significantly increased leg activity over time, with a 133% increase in activity counts by day 5 compared to day 1, indicating that such training can greatly enhance overall physical activity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive treadmill training in the acute phase after ischemic stroke. Strømmen, AM., Christensen, T., Jensen, K.[2018]

A randomized controlled trial with 33 chronic stroke patients showed that a 4-week treadmill training program significantly improved gait velocity and dynamic balance ability compared to traditional training, indicating its effectiveness for rehabilitation.

The study found no adverse effects from the training, suggesting that challenging treadmill speed-dependent gait and balance training is a safe and feasible option for stroke patients with low ambulation ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of challenging treadmill speed-dependent gait and perturbation-induced balance training in chronic stroke patients with low ambulation ability: a randomized controlled trial. Hu, J., Jin, L., Wang, Y., et al.[2023]

In a study involving 19 chronic stroke patients, those who underwent treadmill walking training with rhythmic auditory stimulation (TRAS) showed significant improvements in various gait parameters compared to those who trained with over ground walking (ORAS).

The TRAS group demonstrated enhanced walking speed, step cycle, step length of the unaffected limb, and overall gait ability, suggesting that treadmill training with rhythmic auditory feedback is an effective rehabilitation method for improving gait in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Park, J., Park, SY., Kim, YW., et al.[2018]

The GAITFAST study is investigating the effectiveness of treadmill-based robot-assisted gait training (RTGT) versus therapist-assisted treadmill gait training (TTGT) in improving gait speed recovery in 120 first-ever ischemic stroke patients over a 6-month period.

This clinical trial will assess various outcomes, including gait speed and neurological impairments, to understand the mechanisms of recovery from stroke, providing valuable insights into rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kolářová, B., Šaňák, D., Hluštík, P., et al.[2022]

A study involving 180 poststroke patients found that combining functional electrical stimulation (FES) with body weight-supported treadmill training (BWSTT) significantly improved gait, balance, and lower limb function compared to BWSTT alone.

The FES plus BWSTT group showed enhanced nerve conduction and evoked potential responses, indicating a positive effect on neural recovery, with no adverse events reported during the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. Bao, X., Luo, JN., Shao, YC., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Locomotor training intensity after stroke: Effects of interval type and mode. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Intensive treadmill training in the acute phase after ischemic stroke. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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]

10. Italy pubmed.ncbi.nlm.nih.gov

Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. [2020]