Impact Of Muscle Vibration On Gait Control

NCT05061238 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 2021-0620NCI-2021-09935
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle

Outcome Measures

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).

  through study completion, an average of 1 year

Study Arms (1)

Vibrating Device

OTHER

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

Interventions

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.

Vibrating Device

Eligibility Criteria

• Age: 6 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

Study Officials

• David McCall

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 29, 2021
• Study Start: October 4, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)