Impact Of Muscle Vibration On Gait Control

Muscle Clinical Trial

Official title:

Impact Of Muscle Vibration On Gait Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061238
• Other study ID #: 2021-0620
• Secondary ID: NCI-2021-09935
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: David McCall
• Phone: 713) 792-6604
• Email: dmccall1[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle

Intervention

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.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center