Training the Brain with a Robotic Device for Balance Recovery

NCT02765425 | Withdrawn FDA Device

• 1 other identifier: 204820
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 (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

Conditions

Fall Risk; Healthy Elderly

Outcome Measures

Primary Outcomes (1)

• Change in Number of Falls

  Fall Incidence Questionnaire that records the self-reported number and type of falls.

  Prior to training (baseline) and after 3 months training

Secondary Outcomes (1)

• ABC Fear of Falling Questionnaire

  Prior to training (baseline) and again after 3 months training

Study Arms (2)

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.

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.

Interventions

AMES DEVICE

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.

Training Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• AMES Technology: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

Study Officials

• John R Jefferson, PhD, PT

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: May 6, 2016
• Study Start: August 30, 2017
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: September 3, 2024

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)