ACTIVE_NOT_RECRUITING

Impact Of Muscle Vibration On Gait Control

Talk to us

Conditions

Muscle

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact Of Muscle Vibration On Gait Control

Quick Facts

Study Start:2021-10-04
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05061238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects between the ages of 6 and 39 years.
  2. * 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.
  3. * History of any type of cancer-
  4. * Diagnosed with peripheral neuropathy-associated gait dysfunction as defined by the treating physician.
  5. * Able (in the Investigators estimation) and willing to comply with all study requirements.
  6. * Subjects must be able to walk; assistance of a walker or similar support apparatus is allowed.
  7. * Patients with ankle foot orthosis (AFOs) are allowed but will need to be removed prior to testing.
  1. * Participants with amputations, prosthetics, congenital malformations or any severe lower extremity deformities affecting gait before trials.
  2. * Abnormalities of the lower extremities as determined by the investigator.
  3. * Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
  4. * 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.
  5. * Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrolment
  6. * Pregnant women
  7. * Children \<15 years old
  8. * Blind

Contacts and Locations

Principal Investigator

David McCall
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • David McCall, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-04
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-10-04
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Muscle