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

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ClinicalTrials.gov Identifier: NCT01158781
Recruitment Status : Active, not recruiting
First Posted : July 8, 2010
Last Update Posted : September 14, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Traumatic Brain Injury Behavioral: Experimental: gait, balance, arm function, cognition

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Life Role Participation Through Integrated Cognitive and Motor Training for Individuals With TBI
Study Start Date : May 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01158781     History of Changes
Other Study ID Numbers: PT074749
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Janis Daly, North Florida/South Georgia Veterans Health System:
motor learning
Functional electrical stimulation

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries