Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT02765425 |
Other study ID # |
204820 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 30, 2017 |
Est. completion date |
September 9, 2020 |
Study information
Verified date |
November 2020 |
Source |
University of Arkansas |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
(i.e., 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
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, Arkansas(AR), 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 equilibrium,the 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.