- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765425
Training the Brain With a Robotic Device for Balance Recovery
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
Study Overview
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- University of Arkansas for Medical Sciences Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Training Group
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.
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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.
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No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Falls
Time Frame: Prior to training (baseline) and after 3 months training
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Fall Incidence Questionnaire that records the self-reported number and type of falls.
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Prior to training (baseline) and after 3 months training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ABC Fear of Falling Questionnaire
Time Frame: Prior to training (baseline) and again after 3 months training
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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.
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Prior to training (baseline) and again after 3 months training
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John R Jefferson, PhD, PT, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 204820
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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