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.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle
• Intervention / Treatment: Device: Vibrating Device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vibrating Device; you will be asked to walk up and down a hallway 5 times with the vibrating device strapped to different parts of your leg.	Device: Vibrating Device; The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: David McCall, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2021-0620; NCI-2021-09935 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes