Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652828
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Training At the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients with and Without Cognitive Impairment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAIL
Brief Summary:
The goal of this clinical trial is to determine the effectiveness of perturbation-based balance training PBT in reducing unrecovered falls among geriatric patients aged 70 years with a prospective fall risk of 40 The study will also assess the safety and feasibility of PBT The main research questions are
1 Does PBT lead to a reduction in the number of unrecoverd falls compared to conventional treadmill walking
2 What effects does PBT have on mobility balance performance and cognitive skills
3 PBT will be compared to conventional treadmill walking control group to evaluate its impact on fall prevention
Participants will undergo 3 weeks of either PBT or conventional treadmill training and will attend an assessment before and after the intervention as well as 6 and 12 months follow up Falls will be documented throughout the entire study period using calendars telephone interviews and proxy information The primary outcome unrecovered falls will be recorded after the end of the intervention until 12 months follow up
1 Does PBT lead to a reduction in the number of unrecoverd falls compared to conventional treadmill walking
2 What effects does PBT have on mobility balance performance and cognitive skills
3 PBT will be compared to conventional treadmill walking control group to evaluate its impact on fall prevention
Participants will undergo 3 weeks of either PBT or conventional treadmill training and will attend an assessment before and after the intervention as well as 6 and 12 months follow up Falls will be documented throughout the entire study period using calendars telephone interviews and proxy information The primary outcome unrecovered falls will be recorded after the end of the intervention until 12 months follow up
Detailed Description:
Falls are common and the leading cause of injuries among older adults but falls may be attenuated by the promising and time-efficient intervention called perturbation-based balance training PBT The aim of the TRAIL-study is to confirm the effectiveness of a treadmill PBT protocol for reducing unrecovered falls in geriatric patients with and without cognitive impairment This study is designed as a confirmatory multicenter assessor-blinded randomized controlled study with a 18 month recruiting and a 12 month follow up period The 396 geriatric patients aged 70 years with 40 prospective fall risk and being capable of walking 70 m in a 2-Minute Walk Test receive a 3 week PBT on a treadmill intervention or a conventional treadmill training control group
Follow-up assessments occur shortly after the intervention interval as well as 6 and 12 months thereafter Falls recovered and unrecovered are documented over at least 12 months using calendars telephone interviews and proxy information Secondary outcomes include mobility balance performance concerns about falling physical activity and capacity stepping responses health-related quality of life neuropsychological function cognitive skills mobility reactive dynamic balance and training acceptability The study will be accompanied by a patient advisory board and an expert advisory board and focus groups will be conducted to involve the target group
Based on pilot studies and the available literature we expect a 50 reduction of unrecovered falls during the following year in the intervention group PBT
Follow-up assessments occur shortly after the intervention interval as well as 6 and 12 months thereafter Falls recovered and unrecovered are documented over at least 12 months using calendars telephone interviews and proxy information Secondary outcomes include mobility balance performance concerns about falling physical activity and capacity stepping responses health-related quality of life neuropsychological function cognitive skills mobility reactive dynamic balance and training acceptability The study will be accompanied by a patient advisory board and an expert advisory board and focus groups will be conducted to involve the target group
Based on pilot studies and the available literature we expect a 50 reduction of unrecovered falls during the following year in the intervention group PBT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None