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

This study is currently recruiting participants.
Verified June 2012 by Malcom Randall VA Medical Center
Sponsor:
Information provided by (Responsible Party):
Janis Daly, North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier:
NCT01158781
First received: October 13, 2009
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Craig Handicap Assessment & Reporting Technique (CHART)


Secondary Outcome Measures:
  • cognitive function [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    PASAT

  • arm function [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    AMAT: 13 complex tasks of arm function


Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158781

Contacts
Contact: Carolyn Hanson, Ph.D., OTR 352-376-1611 ext 5110 carolyn.hanson@va.gov

Locations
United States, Florida
Gainesville VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Carolyn Hanson, Ph.D., OTR     352-376-1611 ext 5110     carolyn.hanson@va.gov    
Principal Investigator: Janis Daly, Ph.D., M.S.            
Sponsors and Collaborators
Malcom Randall VA Medical Center
Investigators
Principal Investigator: Janis Daly, Ph.D., M.S. Department of Veterans Affairs
  More Information

No publications provided

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
Study First Received: October 13, 2009
Last Updated: June 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Malcom Randall VA Medical Center:
TBI
motor learning
robotics
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

ClinicalTrials.gov processed this record on May 16, 2013