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

NCT ID: NCT01158781

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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gait, balance, arm function, cognition

12 weeks of training for balance, gait, upper limb function, and cognition

Group Type EXPERIMENTAL

Experimental: gait, balance, arm function, cognition

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Malcom Randall VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Janis Daly

Director, Brain Rehabilitation Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janis Daly, Ph.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

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Gainesville VA Medical Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PT074749

Identifier Type: -

Identifier Source: org_study_id

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