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NCT Number: NCT05061238

Impact Of Muscle Vibration On Gait Control

This is a single-site interventional open label pilot study of a non-significant risk medical device on patients with defined peripheral neuropathy secondary to chemotherapy (N=10). Patients who have received chemotherapy and have evidence of neuropathy will be seen at MD Anderson. Their severity of neuropathy will be documented and assessed by physical therapy, occupational therapy and based on self-reported activities of daily living (ADL) impairment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Muscle

Age range

6 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

Primary Objective:

To assess the effect of a vibrating device applied to selected muscles on the step

Secondary Objectives:

  • To summarize the adverse events of different levels from using the vibrator device in oncologic AYA patients visiting the outpatient clinic.
  • To summarize the irritation, pain, and sensation of the application of vibration by the AYA patients, as determined by the survey during the application

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects between the ages of 6 and 39 years.
  • Study subjects, or their parent/legal guardian for subjects <18 years, must be able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
  • History of any type of cancer-
  • Diagnosed with peripheral neuropathy-associated gait dysfunction as defined by the treating physician.
  • Able (in the Investigators estimation) and willing to comply with all study requirements.
  • Subjects must be able to walk; assistance of a walker or similar support apparatus is allowed.
  • Patients with ankle foot orthosis (AFOs) are allowed but will need to be removed prior to testing.

Exclusion criteria

  • Participants with amputations, prosthetics, congenital malformations or any severe lower extremity deformities affecting gait before trials.
  • Abnormalities of the lower extremities as determined by the investigator.
  • Unstable participants or participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrolment
  • Pregnant women
  • Children <15 years old
  • Blind

Treatment and study plan

Vibrating Device

Device

The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.

Primary outcomes

  1. To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA).

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2021
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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