Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-04-22
Brief Title:
Assessment of Fall Risks and Subject-specific Training for Fall Reduction
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Assessment of Fall Risks and Subject-specific Training for Fall Reduction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The target population of this project is older people with high risks of falls About 30 community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age Falls are the leading cause of fatal and non-fatal injuries and the leading cause traumatic brain injury in older adults Slip-related falls in older adults comprise 40 of outdoor falls and are the leading cause of hip fracture or traumatic head injury In 2012 24 million non-fatal falls were treated in emergency room visits with 30 billion dollars spent on direct medical costs In addition to fractures and traumatic brain injury nonfatal falls frequently lead to reduced levels of activity fear of falling and reduced quality of life Clearly advancing the predictive preventative and rehabilitative methods aimed at reducing the risk of injurious falls in this population is imperative Although falls are multi-factorial in nature there has been few individualized assessment of the biomechanical causes of falls
The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance To conduct subject-specific fall prevention training based on identified individual fall mechanisms
The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance To conduct subject-specific fall prevention training based on identified individual fall mechanisms
Detailed Description:
Forty older adults study group with high risk of fall ie with one or more fall in the past 12 months will be recruited The fall mechanisms will be examined in previous Aims 1 and 2 part of this study
Assessments will be conducted to identify the fall risks and falling mechanisms by measuring subjects responses to the movements of the footplates the subject stands on Training procedures will then be designed for each subject including training both in the research lab once per week and at home three times per week for six weeks The subject will also revisit the lab for a follow-up assessment two months after the 6-week training
Based on the identified falling mechanisms a specific training for each subject will be set up using the sliding stepping fall rehabilitation system for one session per week over six weeks in the lab The participants will also do home training exercises 3 times per week after initial in-lab instructed training Participants will come to the lab and have biomechanical and clinical evaluations before and after the 6-week training called Pre Post and then at a two-month follow-up as the final evaluation for total three times of evaluations
All the subjects will be informed about the experimental procedures and sign an IRB approved consent form prior to study participation and experimental tests
All participants will be protected from the risk of falling with a harness system The harness is mounted in mobile cart A researcher will push the mobile cart following the participants walking while walking on the ground
Home-based training The older adults will also undergo corresponding home-based training Training at home may include normal walking and strength training based on the results in-lab assessments for each older adult and research team instructions
1 If the participant shows instability during walking in any specific perturbation directions or with excessive body swaying left-right forward-backward or any oblique directions based on the initial lab assessment the participant will practice walking with a cellphone strapped on the chest in home training A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions During the walking training at home the participant will set up for a distance of a few meters to walk and repeat the walking distance for 12 to 15 times in a slow speed the participant can take short break between the walking trials
1 For protection of falling risk the participant needs to have a family member to help check the walking ground first before the walking to make sure the ground condition is good and clean
2 If the participant uses a cane or walker regularly the participant will continue using the cane or walker during training at home with the cellphone attached
3 The participant should be monitored by a family member while doing the training at home
4 Training improvement will be evaluated in the weekly lab session It is possible to make adjustment of the training program as the participant progresses
2 If the subject is diagnosed with collapse-related vertical instability associated with falls lower-limb muscle strengthening will be emphasized in the training The subject may work out with a Shuttle Mini-Press AB Squat machine Rowing machine or Upright Row-n-Ride at home The several exercise machines are similar to each other in strengthening the lower limb muscles but the challenging level gradually increasing The Shuttle Mini Press allows the subject to train in stable seated or in-bed postures The AB Squat machine allows squatting exercise with the two feet always on the ground The rower allows seated sliding training The Upright Row-n-Ride allows training in up-and-down fashion The research team will select one machine appropriate for the subject to take home The exercise will be 3-5 sets a day and about 15 repetitions per set In the beginning the exercise can be slower and with fewer repetitions based on the subjects capability The subject can take a short break between the strength training sets As the subject progresses the subject may change from one exercise machine to another
Assessments will be conducted to identify the fall risks and falling mechanisms by measuring subjects responses to the movements of the footplates the subject stands on Training procedures will then be designed for each subject including training both in the research lab once per week and at home three times per week for six weeks The subject will also revisit the lab for a follow-up assessment two months after the 6-week training
Based on the identified falling mechanisms a specific training for each subject will be set up using the sliding stepping fall rehabilitation system for one session per week over six weeks in the lab The participants will also do home training exercises 3 times per week after initial in-lab instructed training Participants will come to the lab and have biomechanical and clinical evaluations before and after the 6-week training called Pre Post and then at a two-month follow-up as the final evaluation for total three times of evaluations
All the subjects will be informed about the experimental procedures and sign an IRB approved consent form prior to study participation and experimental tests
All participants will be protected from the risk of falling with a harness system The harness is mounted in mobile cart A researcher will push the mobile cart following the participants walking while walking on the ground
Home-based training The older adults will also undergo corresponding home-based training Training at home may include normal walking and strength training based on the results in-lab assessments for each older adult and research team instructions
1 If the participant shows instability during walking in any specific perturbation directions or with excessive body swaying left-right forward-backward or any oblique directions based on the initial lab assessment the participant will practice walking with a cellphone strapped on the chest in home training A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions During the walking training at home the participant will set up for a distance of a few meters to walk and repeat the walking distance for 12 to 15 times in a slow speed the participant can take short break between the walking trials
1 For protection of falling risk the participant needs to have a family member to help check the walking ground first before the walking to make sure the ground condition is good and clean
2 If the participant uses a cane or walker regularly the participant will continue using the cane or walker during training at home with the cellphone attached
3 The participant should be monitored by a family member while doing the training at home
4 Training improvement will be evaluated in the weekly lab session It is possible to make adjustment of the training program as the participant progresses
2 If the subject is diagnosed with collapse-related vertical instability associated with falls lower-limb muscle strengthening will be emphasized in the training The subject may work out with a Shuttle Mini-Press AB Squat machine Rowing machine or Upright Row-n-Ride at home The several exercise machines are similar to each other in strengthening the lower limb muscles but the challenging level gradually increasing The Shuttle Mini Press allows the subject to train in stable seated or in-bed postures The AB Squat machine allows squatting exercise with the two feet always on the ground The rower allows seated sliding training The Upright Row-n-Ride allows training in up-and-down fashion The research team will select one machine appropriate for the subject to take home The exercise will be 3-5 sets a day and about 15 repetitions per set In the beginning the exercise can be slower and with fewer repetitions based on the subjects capability The subject can take a short break between the strength training sets As the subject progresses the subject may change from one exercise machine to another
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?:
True
Is an FDA AA801 Violation?:
None