Vibration Therapy for Stroke Survivors

Overseen By Alexander J Barry, MS, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Anti-spasticity medications

Disqualifiers: Orthopedic injuries, Cardiorespiratory disease, 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: 2

Duration: 8-12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Assisted Motion with Enhanced Sensation training can improve arm and hand function in stroke survivors. The study uses a device that aids movement and enhances sensation in the affected arm. Participants are divided into two groups: stroke survivors and uninjured individuals for comparison. Those who had a stroke over six months ago and are not taking specific muscle-relaxing medications may qualify. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance rehabilitation methods for stroke survivors.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking any anti-spasticity medications and have not had a recent change in the use of any medications. If you are on anti-spasticity medications, you must stop taking them for at least 2 weeks before participating.

What prior data suggests that this vibration therapy is safe for stroke survivors?

Research has shown that the Assisted Motion with Enhanced Sensation (AMES) treatment was well-tolerated in previous studies. Most participants improved in their tests, with benefits lasting for six months. Importantly, researchers reported no safety issues, suggesting the treatment is generally safe. The AMES device presents minimal risk and may enhance movement in individuals with long-term stroke effects. However, further studies are needed to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibration Therapy for Stroke Survivors because it introduces a novel approach with the Assisted Motion with Enhanced Sensation (AMES) training. Unlike traditional rehabilitation therapies that primarily focus on repetitive physical exercises, AMES combines assisted motion with sensory feedback to enhance recovery in the affected limbs. This technique aims to engage the brain more effectively by providing enhanced sensory inputs, potentially leading to faster and more significant improvements in motor function. By focusing on sensory enhancement, this therapy could offer a promising alternative to the standard physical therapy options, which often lack this sensory component.

What evidence suggests that Assisted Motion with Enhanced Sensation training is effective for stroke survivors?

Research has shown that Assisted Motion with Enhanced Sensation (AMES), which participants in this trial may receive, can help stroke survivors improve movement. In earlier studies, most participants improved their movement test scores, with these improvements often lasting up to six months. This therapy aids movement and provides extra sensory feedback, which appears to restore function. Importantly, these studies found no major safety problems. This method has also reduced movement problems in people with spinal cord injuries, suggesting it can support recovery in various conditions. ^{1 2 3 5 6}

Who Is on the Research Team?

William Z Rymer, MD/PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who are looking to improve their arm and hand functions. Participants should be able to understand the study and give consent, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Medically stable

Able to comply with study requirements

I haven't taken any anti-spasticity medications in the last 2 weeks.

Exclusion Criteria

I have recently changed my medication.

I have had orthopedic surgeries or injuries.

Unstable Medical conditions or any other clinical observations that may affect the candidates performance, health, safety, or ability to participate in the study as determined by the treating therapist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive wrist/elbow robotic training combined with proprioceptive training using the AMES device

8-12 weeks

2-4 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Assisted Motion with Enhanced Sensation training

Trial Overview The study tests if tendon vibration can enhance robotic training for the wrist/elbow combined with body awareness exercises to improve motor function in chronic stroke survivors.

How Is the Trial Designed?

Group I: Stroke Intervention Experimental Treatment 1 Intervention

In this arm, the participant will be scheduled to come to the laboratory 2-4 times per week and spend 30 minutes using the Assisted Motion with Enhanced Sensation (AMES) treatment device on the affected side of the upper limb.

Group II: Uninjured Control Intervention Active Control 1 Intervention

In this arm the uninjured controls will perform the same interventions as the stroke group. The uninjured control group will perform the tests and interventions with their dominant arm/hand.

Assisted Motion with Enhanced Sensation training is already approved in United States for the following indications:

Approved in United States as Assisted Movement with Enhanced Sensation (AMES) for:

• Rehabilitation of chronic stroke patients with severe motor impairments

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

A local vibration stimulus training program significantly improved postural sway and gait in 31 chronic stroke patients compared to a sham group, with notable enhancements in both standing balance and walking metrics after six weeks of training.

The training group showed greater improvements in postural sway distance and velocity, as well as gait speed, cadence, step length, and single limb support time, indicating that this intervention can effectively aid rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a local vibration stimulus training programme on postural sway and gait in chronic stroke patients: a randomized controlled trial. Lee, SW., Cho, KH., Lee, WH.[2016]

A new method providing real-time auditory feedback about arm movement trajectories is being tested for its effectiveness in motor rehabilitation for stroke patients, specifically targeting 13 subacute stroke patients with hemiparesis over 12 therapy sessions.

The study aims to demonstrate that this auditory feedback will lead to a significant improvement in arm function, as measured by the Box and Block Test, compared to a control group receiving sham feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement Sonification in Stroke Rehabilitation. Schmitz, G., Bergmann, J., Effenberg, AO., et al.[2020]

In a study involving 53 stroke patients, 6 weeks of whole-body vibration therapy did not show any significant advantages over exercise therapy on music for improving balance and daily activities.

Both therapies were safe, with no reported side effects, and neither method demonstrated superior efficacy in recovery outcomes at 6 and 12 weeks post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of 6-week whole-body vibration on balance recovery and activities of daily living in the postacute phase of stroke: a randomized, controlled trial. van Nes, IJ., Latour, H., Schils, F., et al.[2022]

A study involving 31 stroke survivors showed that six weeks of whole-body vibration (WBV) training did not provide any significant benefits over a placebo treatment, indicating that WBV may not be an effective rehabilitation method for this population.

While both groups experienced small improvements in muscle strength and gait performance, these changes were not significantly different between the WBV and placebo groups, suggesting that the effects were within normal variation rather than a result of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No specific effect of whole-body vibration training in chronic stroke: a double-blind randomized controlled study. Brogårdh, C., Flansbjer, UB., Lexell, J.[2022]

A systematic review of eight randomized controlled trials involving 271 stroke patients found no significant improvements in balance, mobility, or muscle strength from whole body vibration therapy.

The results indicate that whole body vibration does not have a clear beneficial effect on balance or gait performance in stroke patients, highlighting the need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of whole body vibration on balance, gait performance and mobility in people with stroke: a systematic review and meta-analysis. Yang, X., Wang, P., Liu, C., et al.[2022]

A pilot study demonstrated that applying subthreshold tactile sensory noise, like mechanical vibration, to the wrist significantly improved hand dexterity and pinch strength in chronic stroke survivors with sensory deficits.

The improvements in motor function suggest that this method may enhance neuronal connections in the sensoriomotor cortex, indicating potential for a simple wristband device to aid rehabilitation both in clinics and at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of remote sensory noise on hand function post stroke. Seo, NJ., Kosmopoulos, ML., Enders, LR., et al.[2020]

In a study involving 84 individuals with chronic stroke, the addition of whole-body vibration (WBV) to leg exercises did not significantly improve muscle strength, balance, or mobility compared to leg exercises alone.

Despite significant improvements over time in various measures of body function and quality of life, there was no added benefit from using different intensities of WBV, indicating that traditional leg exercises may be sufficient for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration Intensities in Chronic Stroke: A Randomized Controlled Trial. Liao, LR., Ng, GY., Jones, AY., et al.[2022]

A study involving subacute and chronic stroke patients showed that using a robotic system for intensive, high-frequency vibration treatment significantly improved upper limb sensitivity and motor function compared to conventional rehabilitation alone.

Patients receiving robotic treatment demonstrated better integration of the affected limb and reported higher quality of life, indicating that this approach enhances both the quantity and quality of movement post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Intensive Vibratory Treatment with a Robotic System on the Recovery of Sensation and Function in Patients with Subacute and Chronic Stroke: A Non-Randomized Clinical Trial. Rodríguez-Pérez, MP., Sánchez-Herrera-Baeza, P., Cano-de-la-Cuerda, R., et al.[2022]

Whole body vibration therapy (WBV) significantly improved walking speed in patients with poststroke hemiplegia, as measured by the Timed 10-Meter Walk Test, with improvements noted at 1 week, 1 month, and 3 months after starting therapy.

The study indicates that WBV may be an effective complementary treatment for enhancing gait rehabilitation and functional outcomes in patients experiencing calf muscle spasticity, based on a single-blind randomized controlled trial involving 21 participants over 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Whole Body Vibration Therapy on Spasticity and Disability of the Patients with Poststroke Hemiplegia. Alp, A., Efe, B., Adalı, M., et al.[2023]

The AMES treatment, which combines assisted movement with vibration to the antagonist muscle, led to significant improvements in strength and active motion in the hands and wrists of individuals with chronic, incomplete tetraplegia, after 25 sessions over 9 to 13 weeks.

Five out of ten participants reported a return of sensation in their fingers after just a few treatment sessions, suggesting that AMES may not only improve motor function but also enhance sensory perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assisted movement with proprioceptive stimulation reduces impairment and restores function in incomplete spinal cord injury. Backus, D., Cordo, P., Gillott, A., et al.[2014]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18645190/

Assisted movement with enhanced sensation (AMES) Results: Most subjects improved on most tests, and gains were sustained for 6 months in most subjects. No safety problems arose.

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/1545968308317437

Assisted Movement With Enhanced Sensation (AMES) Functional tests included gait and weight distribution (lower extremity subjects only) and the Stroke Impact Scale. Results. Most subjects improved on most ...

3. researchgate.net researchgate.net/publication/51419115_Assisted_Movement_With_Enhanced_Sensation_AMES_Coupling_Motor_and_Sensory_to_Remediate_Motor_Deficits_in_Chronic_Stroke_Patients

(PDF) Assisted Movement With Enhanced Sensation (AMES) Conventional methods of rehabilitation in patients with chronic, severe motor impairments after stroke usually do not lessen paresis.

4. withpower.com withpower.com/trial/phase-stroke-9-2024-8918f

Vibration Therapy for Stroke Survivors Additionally, assisted movement with enhanced sensation has been shown to reduce impairments and restore function in people with spinal cord injuries, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2910093/

Rehabilitation After Stroke: Current State of the Science Most positive CIMT trials were performed in chronic stroke patients, but when CIMT is administered at the acute and subacute stages, results are more equivocal, ...

6. bohrium.com bohrium.com/paper-details/assisted-movement-with-enhanced-sensation-ames-coupling-motor-and-sensory-to-remediate-motor-deficits-in-chronic-stroke-patients/811910619979579392-10163

Assisted Movement With Enhanced Sensation (AMES): Coupling ... The AMES treatment device appears to have minimal risk and may improve motor function in chronic stroke patients. Future studies are needed to determine its ...