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Restoration of Life Role Participation Through Cognitive and Motor Training for TBI

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Janis Daly, North Florida/South Georgia Veterans Health System Identifier:
First received: October 13, 2009
Last updated: September 12, 2016
Last verified: September 2016
The purpose of this study is to restore life role participation for those with TBI by customizing, applying, and testing integrated cognitive and motor training protocols that were successful in populations with impairments similar to TBI. The treatment protocols are based on principles of brain plasticity and re-learning, required to restore cognitive and motor function. The intervention targets an array of impairments that are obstacles to life role participation. These include cognitive attention and executive control; motor control for upper limb function; balance and gait; and cognitive executive control of simultaneous cognitive and motor tasks required by everyday tasks. The intervention utilizes training specificity, framing the intervention within functional task and life role activity component practice.

Condition Intervention
Traumatic Brain Injury
Behavioral: Experimental: gait, balance, arm function, cognition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Life Role Participation Through Integrated Cognitive and Motor Training for Individuals With TBI

Further study details as provided by Malcom Randall VA Medical Center:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Week 12 ]
    Craig Handicap Assessment & Reporting Technique (CHART)

Secondary Outcome Measures:
  • cognitive function [ Time Frame: week 12 ]

  • arm function [ Time Frame: week 12 ]
    AMAT: 13 complex tasks of arm function

Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: TBI standard care
This group will receive no study related interventions.
Experimental: gait, balance, arm function, cognition
12 weeks of training for balance, gait, upper limb function, and cognition
Behavioral: Experimental: gait, balance, arm function, cognition
12 weeks of training for balance, gait, upper limb function, and cognition, including functional electrical stimulation with surface electrodes, robotics, and motor learning

Detailed Description:
The investigators will use an assessment and treatment decision schema that has been successful in restoration of life role participation for stroke survivors and a comparable schema used for cognitive training for TBI patients. The subject assessment and decision schema will be used to identify for each subject, the optimal array of impairment interventions. The proposed treatment will optimize outcome by customizing the intervention and use of technologies, while ensuring the application of the array of impairment interventions required to produce restoration of function and life role participation. The investigators will target an array of impairments preventing participation in life role activities, which will include dyscoordination and weakness of upper limb, impaired balance, gait deficits, and impaired attention and executive function. In treatment, the investigators will use a dual-task paradigm combining motor and cognitive training, with treatment extending to the every day environment. Treatment will be up to 5 times/wk, 5hrs/day for 12 weeks.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medically Stable
  • Age > 18 years
  • Ability to walk at least with the minimum assistance of one person or an assistive device
  • At least 6 months post injury
  • Ability to follow 2 stage commands

Exclusion Criteria:

  • pacemaker
  • Acute medical conditions
  • potential subjects will undergo a screening evaluation to determine eligibility for study entry
  Contacts and Locations
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Please refer to this study by its identifier: NCT01158781

United States, Florida
Gainesville VA Medical Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Malcom Randall VA Medical Center
Principal Investigator: Janis Daly, Ph.D., M.S. VA Office of Research and Development
  More Information

Responsible Party: Janis Daly, Director, Brain Rehabilitation Research Center, North Florida/South Georgia Veterans Health System Identifier: NCT01158781     History of Changes
Other Study ID Numbers: PT074749
Study First Received: October 13, 2009
Last Updated: September 12, 2016

Keywords provided by Malcom Randall VA Medical Center:
motor learning
Functional electrical stimulation

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries processed this record on April 26, 2017