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Completed

NCT Number: NCT01158781

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gainesville VA Medical Center

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: gait, balance, arm function, cognition

Behavioral

12 weeks of training for balance, gait, upper limb function, and cognition, including functional electrical stimulation with surface electrodes, robotics, and motor learning

Primary outcomes

  1. Berg Balance

    Time frame: week 12

    Balance function

Sponsors and collaborators

Lead sponsor

Malcom Randall VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2010
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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