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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: gait, balance, arm function, cognition
Sponsored by
Malcom Randall VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, motor learning, robotics, Functional electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gainesville VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gait, balance, arm function, cognition

Arm Description

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

Outcomes

Primary Outcome Measures

Berg Balance
Balance function

Secondary Outcome Measures

Full Information

First Posted
October 13, 2009
Last Updated
March 23, 2019
Sponsor
Malcom Randall VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01158781
Brief Title
Restoration of Life Role Participation Through Cognitive and Motor Training for TBI
Official Title
Restoration of Life Role Participation Through Integrated Cognitive and Motor Training for Individuals With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malcom Randall VA Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
TBI, motor learning, robotics, Functional electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gait, balance, arm function, cognition
Arm Type
Experimental
Arm Description
12 weeks of training for balance, gait, upper limb function, and cognition
Intervention Type
Behavioral
Intervention Name(s)
Experimental: gait, balance, arm function, cognition
Intervention Description
12 weeks of training for balance, gait, upper limb function, and cognition, including functional electrical stimulation with surface electrodes, robotics, and motor learning
Primary Outcome Measure Information:
Title
Berg Balance
Description
Balance function
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis Daly, Ph.D., M.S.
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gainesville VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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