Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453473
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults Cycling Skills
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults Cycling Skills and Behavior BiPerAge a Single Blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BiPerAge
Brief Summary:
The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics PerStBiRo system that can challenge balance while sitting With this system unexpected perturbations can be provided under controlled and safe conditions Within the BiPerAge-project it will be evaluated if 20 training sessions 20 minutes each on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults age 65 years and older The ability to cycle safely will be tested prior and after the training period using a cycling course which consists of variant tasks requiring motor and cognitive skills
Detailed Description:
Cycling is a form of physical activity that is positively associated with health and functional benefits However there is a significant association between increased bicycle use and bicycle accidents with higher risks of severe injuries especially for older adults This could be partly explained by deterioration of the balance control during aging On the one hand training of balance-challenging situations in daily traffic situation is hardly possible under real-world conditions for safety reasons On the other hand the use of a stationary bicycle alone has not been shown to specifically train balance skills and cycling competence To overcome this issue the Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics PerStBiRo system that can challenge balance while riding in a controlled and safe condition
The main and overarching objective of our proposed project is to investigate transfer effects of a training on the PerStBiRo system with perturbation PerTSBR - intervention group on cycling competence of community-dwelling older adults age 65 years and older in comparison to a training on the same system without perturbation TSBR - active control group The cycling competence as our primary outcome will be measured by a standardized cycle course before and after the 3 months intervention period The cycle course which is validated in a recent study SiFAr of our research group consists of various tasks requiring motor and cognitive skills related to traffic situations in daily life
The main and overarching objective of our proposed project is to investigate transfer effects of a training on the PerStBiRo system with perturbation PerTSBR - intervention group on cycling competence of community-dwelling older adults age 65 years and older in comparison to a training on the same system without perturbation TSBR - active control group The cycling competence as our primary outcome will be measured by a standardized cycle course before and after the 3 months intervention period The cycle course which is validated in a recent study SiFAr of our research group consists of various tasks requiring motor and cognitive skills related to traffic situations in daily life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None