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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158781
• Other study ID #: PT074749
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: October 2017

Study information

• Verified date: March 2019
• Source: Malcom Randall VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
United States	Gainesville VA Medical Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Malcom Randall VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance	Balance function	week 12