Treadmetrix Validation for Balance Assessment

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Chronic pain, Use of assistive device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special treadmill that uses a computer to control its movements. It is likely aimed at people who need to test or improve their balance. The treadmill creates specific movements to see how well someone can stay balanced.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the Treadmetrix treatment for balance assessment differ from other treatments?

Treadmetrix is unique because it likely uses advanced technology, such as sensors or computerized systems, to assess and improve balance, which may offer more precise and objective measurements compared to traditional methods. This approach can help in tracking progress and tailoring rehabilitation programs more effectively. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Treadmetrix for balance assessment?

The research on balance assessment tools like the Balance Master and Balance Computerized Adaptive Test shows that objective measures can reliably assess balance function in patients with conditions like stroke. This suggests that similar tools, such as Treadmetrix, could effectively evaluate and support balance improvement. ^{1 3 6 7 8}

Who Is on the Research Team?

Kenton Kaufman, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy adults who can follow instructions and have no medical conditions, injuries, or surgeries affecting balance, mobility, or strength. There are no restrictions based on gender, race, or ethnicity. People with chronic pain in major joints or the back or those using assistive devices like walkers cannot participate.

Inclusion Criteria

I am willing to participate in the study.

I can understand and follow basic instructions.

I am a healthy adult with no conditions or past injuries affecting my balance, mobility, or strength.

Exclusion Criteria

I have ongoing pain in my joints or back.

I use a walker or cane for mobility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Balance Assessment

Subjects undergo a balance assessment on a microprocessor-controlled treadmill

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the balance assessment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Treadmetrix

Trial Overview The study is testing 'Treadmetrix', a microprocessor-controlled treadmill designed to deliver controlled postural disturbances. The goal is to validate how accurately this equipment can simulate these disturbances for research purposes.

How Is the Trial Designed?

Group I: Balance assessment on specialized treadmill Experimental Treatment 1 Intervention

Subjects will undergo a balance assessment on a microprocessor-controlled treadmill

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The Balance Master (BM) tool demonstrated high test-retest reliability for dynamic balance assessments in stroke patients, particularly for tasks involving shifting the center of gravity, with intraclass correlation coefficients (ICCs) of 0.84 for movement path and 0.88 for movement time.

Dynamic balance measures from the BM were found to have concurrent validity with established balance assessments, such as the Berg Balance Scale and gait velocity, indicating that these measures are effective indicators of functional balance performance in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity of measures obtained from stroke patients using the Balance Master. Liston, RA., Brouwer, BJ.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Correlations between subjective rating and objective assessment of balance function in individuals with stroke. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Reliability and validity of measures obtained from stroke patients using the Balance Master. [2022]

3. Sweden pubmed.ncbi.nlm.nih.gov

A comparison of responsiveness and predictive validity of two balance measures in patients with stroke. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Using the systems framework for postural control to analyze the components of balance evaluated in standardized balance measures: a scoping review. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The instrumented single leg stance test detects early balance impairment in people with multiple sclerosis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Validity and Reliability of a Smartphone App for Gait and Balance Assessment. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Augmenting Clinical Outcome Measures of Gait and Balance with a Single Inertial Sensor in Age-Ranged Healthy Adults. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Balance Impairments in People with Early-Stage Multiple Sclerosis: Boosting the Integration of Instrumented Assessment in Clinical Practice. [2022]