Home-Based FES Training for Stroke

(HomeFES Trial)

Overseen By Jessica Pitts, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Botox

Disqualifiers: Osteoporosis, Cognitive impairment, Severe depression, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help stroke survivors improve walking, balance, and mobility. It combines home-based functional electrical stimulation (FES) with special exercises. Participants will train at home for 12 weeks, with initial sessions in a lab. The trial suits individuals who had a stroke over six months ago, experience weakness on one side, can walk 300 feet (with or without a device), and regularly use a smartphone. As an unphased trial, it provides a unique opportunity to explore innovative rehabilitation methods in a flexible home setting.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have uncontrolled or untreated conditions like hypertension or diabetes, you may not be eligible to participate.

What prior data suggests that this home-based FES training is safe for adults with chronic stroke?

Research shows that functional electrical stimulation (FES) is generally safe for stroke patients. In a study with 38 stroke patients, those who used FES along with physical therapy showed noticeable improvements in their abilities. This suggests FES might be effective and is usually well-tolerated.

Additionally, a review of 25 studies on FES systems supports its safety, showing positive results in stroke recovery without major safety issues. These findings suggest that using FES, especially at home, is likely safe for most people.

If FES is approved for another condition, it might indicate safety. However, individual experiences can differ. Discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke rehabilitation methods that often require in-clinic visits, home-based FES (Functional Electrical Stimulation) training offers the convenience of at-home therapy. This approach integrates electrical stimulation with task-specific training to potentially improve gait, mobility, and balance in individuals with chronic stroke. Researchers are excited because this method could make stroke rehabilitation more accessible and personalized, allowing patients to engage in consistent therapy without the need for frequent travel to medical facilities. This could lead to greater adherence to rehabilitation programs and improved outcomes for stroke survivors.

What evidence suggests that home-based FES training is effective for stroke recovery?

Research shows that functional electrical stimulation (FES) can aid stroke recovery. Studies have found that using FES at home improves movement and activity levels. For instance, one study discovered that a 10-week home-based FES program made movement easier and more effective for 52 people with long-term stroke effects. Another study found that FES increased activity levels more than doing nothing or just training alone. These results suggest that using FES at home can enhance walking, balance, and mobility after a stroke. Participants in this trial will engage in a 12-week home-based FES and task-specific training program to further evaluate its feasibility, safety, and efficacy. ^{1 6 7 8 9}

Who Is on the Research Team?

Tanvi Bhatt, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with chronic stroke who can walk at least 300 ft independently and use a smartphone daily. They must have had their stroke over 6 months ago, speak English, and have internet at home. Excluded are those with recent major surgery or hospitalization, severe depression, certain medical conditions like uncontrolled hypertension or epilepsy, pacemaker users, osteoporosis, cognitive impairment or other neurological conditions.

Inclusion Criteria

You use a smartphone every day.

This criterion checks if you have internet or Wi-Fi at your home.

You have weakness on one side of your body.

Exclusion Criteria

You have trouble speaking and understanding language.

You have very severe depression, as measured by a specific scale.

You have a blood clot in a deep vein.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Baseline walking, mobility, balance, and strength assessments conducted in the laboratory

1 week

1 visit (in-person)

Initial Training

Participants are trained in the lab for 6 sessions to prepare for the FES home program

2 weeks

6 visits (in-person)

Home Training Phase 1

Participants undergo home-based FES and task-specific training

2 weeks

Home-based

Mid-Training Assessment

Mid-training assessment conducted to evaluate progress

1 week

1 visit (in-person)

Home Training Phase 2

Continued home-based FES and task-specific training

4 weeks

Home-based

Final Assessment

Final assessment conducted at the end of the training

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-based FES Training

Trial Overview The study tests the safety and effectiveness of using functional electrical stimulation (FES) at home to improve walking, balance and mobility in people with chronic stroke. Participants will receive FES devices for a 12-week training program including initial lab sessions followed by home-based exercises.

How Is the Trial Designed?

Group I: Home-training with functional electrical stimulation Experimental Treatment 1 Intervention

This study employs a single group pre-post design to determine the feasibility, safety and efficacy of a 12-week of home-based combined FES and task-specific training program. Also, this study will test the effect of the same intervention on gait, mobility and balance in adults with chronic stroke.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

The market for functional electrical stimulation (FES) equipment is expanding, with new and innovative products emerging for rehabilitation purposes, including applications for muscle stimulation, cardiovascular exercise, and restoration of function in limbs.

FES technology is also being explored for non-neuromuscular applications, such as controlling epilepsy and enhancing wound healing, indicating its versatility and potential in various medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the functional electrical stimulation equipment market. O'Malley Teeter, J.[2005]

In a study of 38 stroke patients, functional electrical stimulation (FES) combined with physical therapy showed a significant improvement in functional deficits after 4 weeks (p < 0.01).

While there were no significant differences in overall outcomes between the FES and control groups at 4 and 8 weeks, FES-treated patients demonstrated a better rate of recovery in ambulation scores (p < 0.05), suggesting potential additional benefits in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation to the affected lower limb and recovery after cerebral infarction. Macdonell, RA., Triggs, WJ., Leikauskas, J., et al.[2015]

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]

In a study involving 20 chronic stroke patients, daily power-assisted functional electrical stimulation (FES) therapy significantly improved muscle activation and range of motion in the affected upper extremities over a 5-month period.

The FES therapy not only enhanced wrist and finger extension and shoulder flexion but also helped patients perform daily activities more smoothly, suggesting that proprioceptive feedback is crucial for the therapy's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home-based rehabilitation program for the hemiplegic upper extremity by power-assisted functional electrical stimulation. Hara, Y., Ogawa, S., Tsujiuchi, K., et al.[2016]

The developed feedback-controlled functional electrical stimulation (FES) system provides real-time muscle stimulation for hemiplegic patients, helping to prevent drop-foot and quadriceps weakness during gait training.

The FES system uses tilt sensors and footswitches to automatically adjust stimulation parameters, ensuring optimal support for patients as they walk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the tilt sensors feedback controlled FES for hemiplegia. Chen, YL., Shih, YY., Chen, WL., et al.[2020]

Functional electrical stimulation (FES) can help individuals with paralysis, such as those with spinal cord injuries or multiple sclerosis, to exercise, but its long-term use at home depends on initial education and expectations from patients and caregivers.

A conceptual model developed from interviews with 22 stakeholders highlights the importance of motivation, support networks, and clear communication to improve compliance and effectiveness of FES in home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons from Vienna: stakeholder perceptions of functional electrical stimulation technology and a conceptual model for practice. Taylor, MJ., Ruys, AJ., Fornusek, C., et al.[2020]

Functional Electrical Stimulation (FES) can provide health benefits for individuals with paralysis and various health conditions, including musculoskeletal, cardiorespiratory, and renal issues, making it a versatile home-based therapy.

Recent studies, including the EU Project Rise, indicate that FES is effective for patients with denervated muscles and is also a viable exercise option for elderly individuals, enhancing muscle and cardiopulmonary health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home FES: An Exploratory Review. Taylor, MJ., Schils, S., Ruys, AJ.[2020]

A survey of 97 allied health clinicians in Victoria revealed that about 52% have used functional electrical stimulation (FES) in the last two years to help stroke survivors improve arm movement in daily activities.

There is a need for more research to enhance the use of FES in stroke rehabilitation, as clinicians showed variable usage and preferred learning through workplace training from colleagues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using functional electrical stimulation with stroke survivors: A survey of Victorian occupational therapists and physiotherapists. Howlett, O., McKinstry, C., Lannin, NA.[2019]

Functional electrical stimulation (FES) can help restore movement in stroke patients by using a portable neuroelectric stimulator that the patient can control, particularly effective for conditions like dropfoot.

While lower extremity FES systems have been successfully developed to aid walking, creating effective upper extremity systems for hand and finger movements remains a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent applications of functional electrical stimulation to stroke patients in Ljubljana. Vodovnik, L., Kralj, A., Stanic, U., et al.[2005]

A systematic review of 75 studies on noninvasive electrical stimulation (ES) in stroke recovery found that adverse events were mostly minor, with tingling being the most common at 18.1% prevalence among participants.

While some adverse events like itching and discomfort were associated with specific stimulation parameters, the overall safety profile of ES appears favorable, with only two severe adverse events reported, indicating it can be a safe therapeutic option for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. Turnbull, C., Boomsma, A., Milte, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739305/

A systematic review on functional electrical stimulation ... The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aor.14922?af=R

Home‐based functional electrical stimulation protocol for ... This study assessed efficacy and usability of a 10-week home-based rehabilitation protocol for 52 individuals with chronic stroke. The ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999315000441

Functional Electrical Stimulation Improves Activity After ... FES appears to moderately improve activity compared with both no intervention and training alone. These findings suggest that FES should be used in stroke ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39665491/

Home-based functional electrical stimulation protocol for ... Method: This study assessed efficacy and usability of a 10-week home-based rehabilitation protocol for 52 individuals with chronic stroke. The ...

5. ovid.com ovid.com/journals/artorg/fulltext/10.1111/aor.14922~homebased-functional-electrical-stimulation-protocol-for

Home‐based functional electrical stimulation... This study aimed to evaluate the clinical efficacy and usability of a 10‐week home‐based physiotherapeutic intervention that incorporated a dedicated FES system ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04876703

Effectiveness of Multichannel Functional Electrical ... The purpose of this pilot study is to determine whether two weeks of multi-channel FES along with task-specific training will improve UE function.

7. karger.com karger.com/ced/article/53/6/743/893260/Meta-Analysis-of-Functional-Electrical-Stimulation

Meta-Analysis of Functional Electrical Stimulation ... In patients with stroke, both FES combined with OT and tDCS combined with OT exhibit substantial enhancements in limb function and quality of life compared to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8984173/

Therapeutic Effects of Functional Electrical Stimulation on ... This review covers the principles, underlying mechanisms, and therapeutic effects of FES on physical performance and skeletal muscle function in post-stroke ...

9. withpower.com withpower.com/trial/phase-stroke-11-2022-cbf5f

Home-Based FES Training for Stroke (HomeFES Trial) In a study of 38 stroke patients, functional electrical stimulation (FES) combined with physical therapy showed a significant improvement in functional deficits ...