Nerve Stimulation + Knee Brace for Post-Stroke Mobility Improvement

Recruiting at 1 trial location

Overseen By Kristine Hansen, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Musculoskeletal injury, Osteoarthritis, Polyneuropathy, Cognitive impairment, Vision impairment

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Nerve Stimulation + Knee Brace for Post-Stroke Mobility Improvement?

Research shows that functional electrical stimulation (FES) can improve walking ability in stroke patients by stimulating muscles to enhance movement. Studies indicate that FES, when combined with physical therapy, can help improve gait speed and muscle function, suggesting potential benefits for post-stroke mobility. ^{1 2 3 4 5}

Is nerve stimulation with a knee brace safe for humans?

Research on electrical stimulation of peripheral nerves, which is similar to nerve stimulation used with a knee brace, suggests it is generally safe for humans. However, detailed safety data, especially for long-term use, is limited. ^{4 5 6 7 8}

How is the treatment of nerve stimulation and knee brace for post-stroke mobility improvement different from other treatments?

This treatment is unique because it combines peripheral nerve stimulation (using electrical impulses to activate muscles) with a knee brace to improve mobility after a stroke. Unlike traditional methods, this approach uses functional electrical stimulation (FES) to directly stimulate nerves and muscles, potentially offering more precise control and aiding in muscle recovery and joint stability. ^{4 8 9 10 11}

Research Team

James S Sulzer

Principal Investigator

Case Western Reserve University

Eligibility Criteria

This trial is for adults who were independent before and can walk continuously for 30 minutes. It's specifically aimed at those with post-stroke stiff-knee gait, which means they have trouble bending their knee when walking due to a stroke. Participants should have mild to moderate impairment and be able to give consent.

Inclusion Criteria

Premorbidly independent

I am 18 years old or older.

I can walk non-stop for 30 minutes.

Exclusion Criteria

You do not have significant problems with memory or thinking.

My vision does not significantly impact my daily activities.

I don't have severe joint pain or limits on my ability to support weight.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electrical stimulation of the peripheral nerve innervating the rectus femoris to examine reflex excitability

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Commercial knee brace
• Peripheral nerve stimulation

Trial Overview The study tests how electrical stimulation of the nerve that controls the thigh muscle affects reflexes in people with stiff knees after a stroke compared to those without this condition. Additionally, it examines if these reflexes are linked to changes in walking patterns.

Participant Groups

Group I: Post-stroke Stiff-Knee Gait Participants Experimental Treatment 1 Intervention

Individuals with post-stroke Stiff-Knee gait

Group II: Healthy Individuals Experimental Treatment 2 Interventions

Healthy Individuals

Peripheral nerve stimulation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Electrical Stimulation for:

• Pain management
• Muscle rehabilitation
• Neurological disorders

Approved in United States as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Spinal cord injuries
• Muscle paralysis

Approved in Canada as Peripheral Nerve Stimulation for:

• Chronic pain
• Neuropathic pain
• Muscle weakness

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

In a pilot study involving 42 first-stroke patients, adding transcutaneous nerve stimulation to standard early rehabilitation significantly improved postural stability and walking ability compared to standard rehabilitation alone.

At the two-week follow-up, patients receiving transcutaneous nerve stimulation showed better scores on the Postural Assessment Scale and a higher likelihood of walking independently for 50 meters, indicating enhanced recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard early rehabilitation and lower limb transcutaneous nerve or neuromuscular electrical stimulation in acute stroke patients: a randomized controlled pilot study. Yen, HC., Chen, WS., Jeng, JS., et al.[2022]

Functional electrical stimulation (FES) for lower extremity muscles shows consistent therapeutic effects on motor performance in post-stroke individuals, particularly when used as a training modality.

While FES did not demonstrate superior benefits compared to traditional orthotic devices at the activity level, patients preferred using FES, indicating its potential for enhancing rehabilitation experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of functional electrical stimulation on gait in individuals post-stroke. Kafri, M., Laufer, Y.[2022]

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]

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]

Functional electrical stimulation (FES) applied to the paretic peroneal nerve can improve ankle dorsiflexion, balance, and functional mobility in individuals with foot drop after stroke, based on a meta-analysis of 14 studies involving 1115 participants.

However, FES did not significantly enhance gait speed compared to conventional treatments, and the evidence supporting its effectiveness is of low quality and shows high variability, particularly for balance and functional mobility outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation of the peroneal nerve improves post-stroke gait speed when combined with physiotherapy. A systematic review and meta-analysis. Jaqueline da Cunha, M., Rech, KD., Salazar, AP., et al.[2021]

Extraneural electrodes are more stable for long-term use compared to intraneural electrodes, which is important for the safety of chronic electrical stimulation applications.

Current guidelines suggest that chronic stimulation should be kept below 30 Hz and effective stimulation time below 50% to minimize risks, but more comprehensive data is needed to establish safe stimulation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. Günter, C., Delbeke, J., Ortiz-Catalan, M.[2021]

Low frequency electrical stimulation applied during surgery for peripheral nerve injuries can significantly enhance recovery by promoting axon outgrowth and remyelination, potentially improving functional outcomes for patients.

Recent randomized clinical trials provide strong evidence supporting the use of electrical stimulation as a safe and effective adjunct to surgical repair, making it a promising option for improving recovery in patients with nerve injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. Zuo, KJ., Gordon, T., Chan, KM., et al.[2021]

Functional electrical stimulation (FES) has shown significant advancements in treating peripheral nerve injuries, enhancing nerve regeneration and preventing muscle atrophy.

FES is recognized as an effective therapeutic intervention for individuals with peripheral nerve injuries, addressing both recovery and muscle health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advances of functional electrical stimulation in treatment of peripheral nerve injuries]. Lin, S., Xu, J.[2005]

The closed-loop functional electrical stimulation (FES) system significantly improved walking metrics in hemiplegic patients, including velocity, cadence, stride length, and functional ambulation category, after 16 weeks of gait training.

The system effectively addresses quadriceps weakness and drop-foot by stimulating the necessary muscles during different phases of walking, demonstrating its potential for restoring regular walking abilities in hemiplegic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a knee locker with closed-loop functional electrical stimulation (FES) for hemiplegia in gait training. Chen, YL., Chang, WH., Chen, SC., et al.[2006]

Functional neuromuscular electrical stimulation (FES) can effectively produce muscle contractions that aid in joint stability and limb movement, which is crucial for patient recovery after illness or injury.

FES not only helps improve patient function during recovery but also has the potential to transition into neural prosthetic systems for individuals who do not fully regain movement, highlighting its importance in rehabilitation and community healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic FES: from rehabilitation to neural prosthetics. Campbell, JM., Meadows, PM.[2005]

The ActiGait implantable drop foot stimulator significantly improved gait speed and walking endurance in 5 stroke patients, with measurable benefits observed at 6 and 12 weeks post-implantation.

The system restored nearly normal ankle joint kinematics, particularly the initiation angle, which is crucial for preventing falls, indicating its efficacy in enhancing mobility for patients with stroke-related drop foot.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards physiological ankle movements with the ActiGait implantable drop foot stimulator in chronic stroke. Ernst, J., Grundey, J., Hewitt, M., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Standard early rehabilitation and lower limb transcutaneous nerve or neuromuscular electrical stimulation in acute stroke patients: a randomized controlled pilot study. [2022]

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

Therapeutic effects of functional electrical stimulation on gait in individuals post-stroke. [2022]

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

Functional electrical stimulation to the affected lower limb and recovery after cerebral infarction. [2015]

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

Recent applications of functional electrical stimulation to stroke patients in Ljubljana. [2005]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation of the peroneal nerve improves post-stroke gait speed when combined with physiotherapy. A systematic review and meta-analysis. [2021]

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

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. [2021]

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

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. [2021]

8. China pubmed.ncbi.nlm.nih.gov

[Advances of functional electrical stimulation in treatment of peripheral nerve injuries]. [2005]

9. England pubmed.ncbi.nlm.nih.gov

The development of a knee locker with closed-loop functional electrical stimulation (FES) for hemiplegia in gait training. [2006]

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

Therapeutic FES: from rehabilitation to neural prosthetics. [2005]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Towards physiological ankle movements with the ActiGait implantable drop foot stimulator in chronic stroke. [2013]