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

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate how vibration of the tendons enhances arm and hand training in survivors of chronic stroke. The investigators hypothesize that wrist/elbow robotic training, combined with body awareness training will improve arm and hand function in individuals with chronic stroke.

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 data supports the effectiveness of the treatment Assisted Motion with Enhanced Sensation training for stroke survivors?

Research shows that vibration therapy, similar to the treatment being studied, can improve sensation, motor function, and quality of life in stroke patients. Additionally, assisted movement with enhanced sensation has been shown to reduce impairments and restore function in people with spinal cord injuries, suggesting potential benefits for stroke survivors as well. ^{1 2 3 4 5}

Is vibration therapy safe for stroke survivors?

Research on whole-body vibration therapy for stroke survivors suggests it is generally safe, as it has been used in studies to improve balance, gait, and hand function without reported safety concerns. ^{4 6 7 8 9}

How is the Assisted Motion with Enhanced Sensation training treatment different from other treatments for stroke survivors?

Assisted Motion with Enhanced Sensation training is unique because it combines movement assistance with enhanced sensory feedback, often using robotic systems and vibration therapy, to improve motor function and sensation in stroke survivors. This approach is different from standard therapies that may not integrate sensory enhancement with movement assistance. ^{1 2 3 7 10}

Research Team

William Z Rymer, MD/PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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

Able to comply with study requirements

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. Switzerland 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. [2022]

2. England 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. [2016]

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

The Impact of Whole Body Vibration Therapy on Spasticity and Disability of the Patients with Poststroke Hemiplegia. [2023]

4. United States 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. [2022]

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

Assisted movement with proprioceptive stimulation reduces impairment and restores function in incomplete spinal cord injury. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Movement Sonification in Stroke Rehabilitation. [2020]

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

Whole-Body Vibration Intensities in Chronic Stroke: A Randomized Controlled Trial. [2022]

8. England 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. [2022]

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

Effect of remote sensory noise on hand function post stroke. [2020]

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

No specific effect of whole-body vibration training in chronic stroke: a double-blind randomized controlled study. [2022]