Impact Of Muscle Vibration On Gait Control

Running, not enrolling · Not applicable

Conditions studied: Muscle

In brief

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.

Key facts

Study ID

NCT05061238

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2021-10-04

Expected to finish

2027-12-31

Last updated by the study team

2026-06-11

Who can join

Age: 6 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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