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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05107817
Other study ID # 12227
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2025
Est. completion date September 2026

Study information

Verified date April 2024
Source Utah State University
Contact Youngwook Kim
Phone 4352945504
Email youngwook.kim@usu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present clinical trial aims to identify if skills acquired during aquatic exercise are more effectively transferred to a reactive balance task than land exercise. This study is designed as a double-blinded, randomized controlled clinical trial. Forty-four older adults aged 60 years or above who meet the eligibility criteria will be recruited and randomized into an aquatic exercise group or land exercise group. Each group will participate in the same balance training exercise during a single session that includes a ball throwing and catching task. A modified lean-and-release test will be implemented on land immediately before, after, and one week after the training session. The outcomes will include reaction time, rapid response accuracy, and mini-BESTest scores obtained from stepping and grasping reactions.


Description:

During the modified lean-and-release test, there are two possible settings: 1) the leg block is placed in front of both legs, and a safety handle is uncovered; or 2) the leg block is removed, and the safety handle is covered. The leg block and handle cover will be controlled via computer-triggered, servo motors. The testing session will be comprised of three blocks: 1) REACH (grasping a safety handle using their right hand while maintaining both feet fixed), 2) STEP (stepping forward using any leg), and 3) RANDOM (random variations of STEP and REACH).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date September 2026
Est. primary completion date September 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Ability to stand using a double-leg stance for one minute of time - Ability to walk independently - Normal or corrected to normal vision - Normal or corrected to normal hearing based on a qualitative assessment Exclusion Criteria: - Any neurological or musculoskeletal disorders that may inhibit the participation in the training and testing protocols - A concussion within the past one year before the participation - Any cognitive deficiencies (e.g., memory, concentration, or attention disorder) - One or more 'yes' answered on the Physical Activity Readiness Questionnaire (PAR-Q) - Fear of water

Study Design


Intervention

Other:
Exercise intervention
A ball catching and throwing exercise.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eadric Bressel

References & Publications (1)

Bolton DAE, Mansour M. A Modified Lean and Release Technique to Emphasize Response Inhibition and Action Selection in Reactive Balance. J Vis Exp. 2020 Mar 19;(157):10.3791/60688. doi: 10.3791/60688. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reaction time measures (REACH) Hand contact time during REACH following the cable release will be calculated. Immediately before the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (STEP1) Foot-off time during STEP following the cable release will be calculated. Immediately before the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (STEP2) Foot contact time during STEP following the cable release will be calculated. Immediately before the intervention. Duration of each assessment will be 15 minutes.
Primary Rapid response accuracy For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. Immediately before the intervention. Duration of each assessment will be 15 minutes.
Primary Mini-Balance Evaluation Systems Test During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). Immediately before the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (REACH) Hand contact time during REACH following the cable release will be calculated. Immediately after the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (STEP1) Foot-off time during STEP following the cable release will be calculated. Immediately after the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (STEP2) Foot contact time during STEP following the cable release will be calculated. Immediately after the intervention. Duration of each assessment will be 15 minutes.
Primary Rapid response accuracy For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. Immediately after the intervention. Duration of each assessment will be 15 minutes.
Primary Mini-Balance Evaluation Systems Test During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). Immediately after the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (REACH) Hand contact time during REACH following the cable release will be calculated. One week after the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (STEP1) Foot-off time during STEP following the cable release will be calculated. One week after the intervention. Duration of each assessment will be 15 minutes.
Primary Reaction time measures (STEP2) Foot contact time during STEP following the cable release will be calculated. One week after the intervention. Duration of each assessment will be 15 minutes.
Primary Rapid response accuracy For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. One week after the intervention. Duration of each assessment will be 15 minutes.
Primary Mini-Balance Evaluation Systems Test During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). One week after the intervention. Duration of each assessment will be 15 minutes.
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