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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06373276
Other study ID # 1511
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date May 2024

Study information

Verified date April 2024
Source Metro Physical Therapy
Contact dilshaad vad, DPT, MSPT
Phone 9174782444
Email dilshaad.vad@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category. Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention. Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention. Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance. Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: Age of 65 years or older - Able to transfer and walk independently at least 10 feet without an assistive device - Living independently (defined as transferring independently and perform activities of daily life independently) in a home, or condo in the community - Maintain a single legged stance greater than or equal to 2 seconds and less than or equal to 10 seconds bilaterally - A Mini-Cog test (a tool that assesses signs for dementia) score of 3 or greater (appendix IV) - Possession of an I-Phone less than 7 years old - Able to start within 2 weeks of enrollment Exclusion Criteria: - • Unable to comprehend spoken English or communicate verbally in English - Diagnosis of a central neurological disease - Diagnosis of cognitive disease - Surgery or hospitalization within the last 6 months - Active cancer and/or undergoing current treatment - Current utilization of a trainer - Current utilization of a physical therapist for gait, balance, or lower extremity issues

Study Design


Related Conditions & MeSH terms


Intervention

Other:
multiplanar balance training exercise with education
7 minute daily balance training exercises
Behavioral:
education only
5 educational broshures

Locations

Country Name City State
United States Metro PT New York New York

Sponsors (1)

Lead Sponsor Collaborator
Dilshaad Basrai Vad

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Timed up and Go Test measured in Seconds walk 10 feet, turn around and walk back to start position 1 minute
Primary 3 stage balance test measured in seconds tandem gait stance measured up to 10 seconds 20 seconds
Primary 30-second chair stand measured in repeitions Stand up from chair, sit back down and repeat for 30 seconds 40 seconds
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