Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02765425
Status:
WITHDRAWN
Last Update Posted:
2020-11-04
First Post:
2016-04-07
Brief Title:
Training the Brain with a Robotic Device for Balance Recovery
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Training the Brain with a Robotic Device for Balance Recovery in Near-frail Older Adults
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of department staff and COVID
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research objective of this study is to determine whether an intervention and associated robotic device called Assisted Movement with Enhanced Sensation AMES can be used to enhance balance recovery following an unexpected loss of balance by conditioning areas of the brain involved in lower-limb LL motor control It is hypothesized that AMES can improve balance recovery gait and reduce falls in near-frail elderly people by improving LL strength speed and coordination
AMES is a medical intervention and robotic device originally developed to aid patients recovery from injuries to the central nervous system that limit movement Earlier published studies demonstrated a unique property of AMES namely that it is capable of reducing sensorimotor impairment in the severely impaired an underserved population of patients with brain and spinal cord injuries AMES applies assisted movement biofeedback and sensory stimulation simultaneously and non-invasively to the upper or lower limb the initial intent being to address impairments such as weakness spasticity sensory loss and dyssynergia ie co-contraction These reductions in impairment are achieved through cortical plasticity In the present study the same methodology will be applied to the lower limbs of the near-frail elderly to reduce falls by training faster reaction times stronger reactions and more coordinated recoveries from slips and trips
AMES is a medical intervention and robotic device originally developed to aid patients recovery from injuries to the central nervous system that limit movement Earlier published studies demonstrated a unique property of AMES namely that it is capable of reducing sensorimotor impairment in the severely impaired an underserved population of patients with brain and spinal cord injuries AMES applies assisted movement biofeedback and sensory stimulation simultaneously and non-invasively to the upper or lower limb the initial intent being to address impairments such as weakness spasticity sensory loss and dyssynergia ie co-contraction These reductions in impairment are achieved through cortical plasticity In the present study the same methodology will be applied to the lower limbs of the near-frail elderly to reduce falls by training faster reaction times stronger reactions and more coordinated recoveries from slips and trips
Detailed Description:
The specific aim of this study is to determine preliminarily the efficacy of the AMES intervention in helping older adults quickly readjust their posture in order to recover from unexpected loss of equilibrium An AMES device will be placed into operation at the University of Arkansas for Medical Sciences UAMS Out-patient Rehabilitation Therapy Clinic at Fayetteville ArkansasAR where we will recruit 20 healthy but near-frail subjects Ten of these participants will be randomly assigned to a treatment group and the other 10 will be assigned into a control group that will not receive the AMES intervention Before and after 12 weeks of training with the bipedal AMES device ankle strength range of motion proprioception and reaction time as well as gait and whole-body stability following unexpected balance perturbations will be assessed In addition to measuring sensorimotor impairment and static balance equilibriumthe incidence of falls in all 20 participants beginning with enrollment into the study for a total of 6 months will be tracked A reduction in sensorimotor impairment an improvement in dynamic balance and a reduction in fall incidence in the treatment group but not in the control group is expected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None