Fall RiskNCT02765425
Training the Brain with a Robotic Device for Balance Recovery
A study testing AMES in people with Fall Risk and Healthy Elderly, run by University of Arkansas at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Risk, Healthy Elderly
- What is being tested?
- AMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women, ages 65 years to 90 years old, inclusive
- With a history of one or more falls in the last 2 years
- Able to independently ambulate
- Ability to fit the legs into the AMES device
- Cognitively able to comply with instructions
Who cannot join
- Presence of substantial somatosensory deficits in the legs (i.e., <70% correct on the Joint Position Test)
- Co-morbidities that affect the ability to exercise or move the legs
- Significant history of cardiac or peripheral vascular problems that would preclude seated ankle exercises
- Participation in any other concurrent study involving the LL
- Initiation of any considered new exercise or therapeutic regimens during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
Official title: Training the Brain with a Robotic Device for Balance Recovery in Near-frail Older Adults
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
Read the 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, 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.
- Conditions
- Fall Risk, Healthy Elderly
- Being tested
- AMES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMESDevice
Subjects will be trained while seated on the AMES device. As the footplate of the device rotates the ankle ±15 deg in dorsiflexion and plantarflexion, the participant will assist that motion. Vibration (2-3 mm at 60 pulses/s) will be applied to the tibialis anterior tendon during plantarflexion and to the Achilles tendon during dorsiflexion. To assist participants in the assisted movement task, the AMES biofeedback screen will provide real-time visual feedback of the volitional ankle torque that the participants actively apply to the AMES device. Each training session will include 15 min of training of each ankle; training sessions will be conducted 3 times/week over a 12-week period, for a total of 9 hours of training on each ankle.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Subjects will receive the same outcome measures at baseline, after 3 months training and 6 months later. Intervention will comprise of three sessions seated at the AMES device. Each training session will include 15 min of training of each ankle. Training sessions will be conducted 3 times/week over a 12-week period, for a total of 9 hours of training on each ankle. Receives: Device: AMES |
| Control Group | No intervention | Subjects will receive no intervention. Subjects will receive all outcome measures at baseline and at 3 months post enrollment. Subjects will also receive a fall-incidence reporting form 9 months post enrollment. No other intervention - i.e. no treatment - is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Falls
Fall Incidence Questionnaire that records the self-reported number and type of falls.
Measured: Prior to training (baseline) and after 3 months training
Secondary outcomes (1)
ABC Fear of Falling Questionnaire
The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report measure in which subjects rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items.
Measured: Prior to training (baseline) and again after 3 months training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start30 Aug 2017
- Primary completion9 Sep 2020 (estimated)
- Study completion9 Sep 2020 (estimated)
Why it stopped: Loss of department staff and COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- AMES Technology
- Responsible party
- Sponsor
- Investigators
- John R Jefferson, PhD, PT, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765425
- Sponsor's protocol ID
- 204820
- Status last verified
- Nov 2020
- First submitted
- 7 Apr 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training the Brain with a Robotic Device for Balance Recovery in Near-frail Older Adults
- ClinicalTrials.gov ID
- NCT02765425
- Acronym / sponsor ID
- 204820
- Conditions
- Fall Risk, Healthy Elderly
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of department staff and COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- AMES Technology
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 9 Sep 2020 (estimated)
- Study completion
- 9 Sep 2020 (estimated)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Device: AMESSubjects will receive the same outcome measures at baseline, after 3 months training and 6 months later. Intervention will comprise of three sessions seated at the AMES device. Each training session will include 15 min of training of each ankle. Training sessions will be conducted 3 times/week over a 12-week period, for a total of 9 hours of training on each ankle. |
| Control Group | No intervention | –Subjects will receive no intervention. Subjects will receive all outcome measures at baseline and at 3 months post enrollment. Subjects will also receive a fall-incidence reporting form 9 months post enrollment. No other intervention - i.e. no treatment - is given. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Men and women, ages 65 years to 90 years old, inclusive
- With a history of one or more falls in the last 2 years
- Able to independently ambulate
- Ability to fit the legs into the AMES device
- Cognitively able to comply with instructions
Key exclusion criteria (5 listed)
- Presence of substantial somatosensory deficits in the legs (i.e., <70% correct on the Joint Position Test)
- Co-morbidities that affect the ability to exercise or move the legs
- Significant history of cardiac or peripheral vascular problems that would preclude seated ankle exercises
- Participation in any other concurrent study involving the LL
- Initiation of any considered new exercise or therapeutic regimens during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMESSubjects will be trained while seated on the AMES device. As the footplate of the device rotates the ankle ±15 deg in dorsiflexion and plantarflexion, the participant will assist that motion. Vibration (2-3 mm at 60 pulses/s) will be applied to the tibialis anterior tendon during plantarflexion and to the Achilles tendon during dorsiflexion. To assist participants in the assisted movement task, the AMES biofeedback screen will provide real-time visual feedback of the volitional ankle torque that the participants actively apply to the AMES device. Each training session will include 15 min of training of each ankle; training sessions will be conducted 3 times/week over a 12-week period, for a total of 9 hours of training on each ankle. | Device | Training Group |
Primary outcome
Change in Number of Falls
Time frame: Prior to training (baseline) and after 3 months training
Fall Incidence Questionnaire that records the self-reported number and type of falls.
1 secondary outcome
ABC Fear of Falling Questionnaire
Time frame: Prior to training (baseline) and again after 3 months training
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Jefferson, PhD, PT principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMES in people with Fall Risk and Healthy Elderly, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Falls (time frame: Prior to training (baseline) and after 3 months training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.