Effect of muscle vibration on walking in cancer patients with nerve damage

Impact Of Muscle Vibration On Gait Control

This study is testing whether a vibrating device can help young cancer patients with nerve damage walk better and feel more stable.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 6 Years to 39 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05061238 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the impact of a vibrating device on the gait of patients aged 6 to 39 who have developed peripheral neuropathy due to chemotherapy. Conducted at MD Anderson Cancer Center, the study will assess the severity of neuropathy and its effect on daily activities through physical and occupational therapy evaluations, as well as patient self-reports. The primary goal is to determine how muscle vibration influences walking stability, while secondary objectives include monitoring any adverse effects and patient feedback regarding the device's application.

Who should consider this trial

Good fit: Ideal candidates are cancer survivors aged 6 to 39 with chemotherapy-induced peripheral neuropathy affecting their gait.

Not a fit: Patients with severe lower extremity deformities or those using prosthetics may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could improve walking ability and quality of life for young cancer survivors experiencing neuropathy.

How similar studies have performed: While similar approaches have been explored, this specific application of muscle vibration in this patient population is relatively novel.

Eligibility criteria

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

Where this trial is running

Houston, Texas

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

Study contacts

• Principal investigator: David McCall — M.D. Anderson Cancer Center
• Study coordinator: David McCall

Conditions: Muscle