Nerve Stimulation + Knee Brace for Post-Stroke Mobility Improvement

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by James S Sulzer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

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

No Placebo Group

Approved in 3 Jurisdictions

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}

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.

Trial 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 (Procedure)
• Peripheral nerve stimulation (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas at Austin Austin, TX

MetroHealth Medical Center Cleveland, OH

Who Is Running the Clinical Trial?

University of Texas at Austin Lead Sponsor

MetroHealth Medical Center Lead Sponsor

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

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] We investigated adding lower limb transcutaneous nerve stimulation or neuromuscular electrical stimulation to standard early rehabilitation in acute stroke patients.

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

Therapeutic effects of functional electrical stimulation on gait in individuals post-stroke. [2022] Functional electrical stimulation (FES) to lower extremity (LE) muscles is used by individuals post-stroke as an alternative to mechanical orthotic devices during gait or as a training modality during rehabilitation. Technological developments which improve the feasibility, accessibility and effectiveness of FES systems as orthotic and training devices, highlight the potential of FES for rehabilitating LE function in individuals post-stroke. This study presents a systematic review of the carryover effects of LE FES to motor performance when stimulation is not applied (therapeutic effects) in subjects post-stroke. A description of advances in FES technologies, with an emphasis on systems designed to promote LE function is included, and mechanisms that may be associated with the observed therapeutic effects are discussed. Eligible studies were reviewed for methodological quality, population, intervention and outcome characteristics. Therapeutic effects of FES were consistently demonstrated at the body function and activity levels when it was used as a training modality. Compared to matched treatments that did not incorporate FES, no definite conclusions can be drawn regarding the superiority of FES. When FES was used as an alternative to an orthotic device, it had no superior therapeutic effects at the activity level, yet patients still seemed to prefer it.

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

Functional electrical stimulation to the affected lower limb and recovery after cerebral infarction. [2015] Functional electrical stimulation (FES) may improve recovery after stroke. We studied its effects in 38 postcerebral infarct patients. Twenty were randomly assigned to receive FES producing ankle dorsiflexion on the affected side and physical therapy. The remaining 18 received physical therapy only. Subjects were evaluated prior to commencing therapy, at its completion after 4 weeks, and again 4 weeks later using functional and electrophysiological measures. Functional deficit in most patients improved (p

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

Recent applications of functional electrical stimulation to stroke patients in Ljubljana. [2005] Functional movements can be restored after stroke by portable neuroelectric stimulator controlled by the patient. This field of activity is called functional electrical stimulation (FES). A common example of FES is electric stimulation of the peroneal to prevent dropfoot. A more sophisticated multichannel enables stimulation of more than one paralyzed muscle of the leg. This system is used temporarily to facilitate recovery of muscle function following stroke. Upper extremity FES systems have proven more difficult to develop than lower extremity systems designed to improve walking. A single-channel hand stimulator is available to assist finger movements.

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] Functional electrical stimulation (FES) applied to the paretic peroneal nerve has positive clinical effects on foot drop secondary to stroke.

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

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. [2021] Electrical stimulation of peripheral nerves is used in a variety of applications such as restoring motor function in paralyzed limbs, and more recently, as means to provide intuitive sensory feedback in limb prostheses. However, literature on the safety requirements for stimulation is scarce, particularly for chronic applications. Some aspects of nerve interfacing such as the effect of stimulation parameters on electrochemical processes and charge limitations have been reviewed, but often only for applications in the central nervous system. This review focuses on the safety of electrical stimulation of peripheral nerve in humans.

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

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. [2021] Peripheral nerve injuries are common and frequently result in incomplete functional recovery even with optimal surgical treatment. Permanent motor and sensory deficits are associated with significant patient morbidity and socioeconomic burden. Despite substantial research efforts to enhance peripheral nerve regeneration, few effective and clinically feasible treatment options have been found. One promising strategy is the use of low frequency electrical stimulation delivered perioperatively to an injured nerve at the time of surgical repair. Possibly through its effect of increasing intraneuronal cyclic AMP, perioperative electrical stimulation accelerates axon outgrowth, remyelination of regenerating axons, and reinnervation of end organs, even with delayed surgical intervention. Building on decades of experimental evidence in animal models, several recent, prospective, randomized clinical trials have affirmed electrical stimulation as a clinically translatable technique to enhance functional recovery in patients with peripheral nerve injuries requiring surgical treatment. This paper provides an updated review of the cellular physiology of electrical stimulation and its effects on axon regeneration, Level I evidence from recent prospective randomized clinical trials of electrical stimulation, and ongoing and future directions of research into electrical stimulation as a clinically feasible adjunct to surgical intervention in the treatment of patients with peripheral nerve injuries.

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

[Advances of functional electrical stimulation in treatment of peripheral nerve injuries]. [2005] To review the advances of functional electrical stimulation (FES) in treatment of peripheral nerve injuries.

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] A knee locker with closed-loop functional electrical stimulation (FES) system has been developed to prevent the quadriceps weakness and the drop-foot of the hemiplegia during gait training.

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

Therapeutic FES: from rehabilitation to neural prosthetics. [2005] The purpose of this paper is to review the therapeutic applications of electrical stimulation and to focus on functional neuromuscular electrical stimulation (FES), which is the production of useful muscle contractions for joint stability and limb movement. The use of FES to improve patient function during the recovery period after illness or injury and the transition to FES neural prosthetic systems for patients who do not fully recover will be discussed. Emphasis will be given to the maintenance of posture and the production of purposeful movement from the perspective of technologies and clinical strategies that are available today and from the perspective of those technologies that have the potential for transfer to community health care in the near future.

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

Towards physiological ankle movements with the ActiGait implantable drop foot stimulator in chronic stroke. [2013] Functional electrical stimulation represents an alternative to conventional and passive ankle foot orthosis (AFO) for the treatment of stroke-related drop foot. We evaluated the implantable 4-channel stimulator ActiGait, which selectively and directly stimulates the peroneal nerve. In addition, it bypasses the need for surface electrodes and cables.