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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01158781
Other study ID # PT074749
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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