This trial is active, not recruiting.

Condition traumatic brain injury
Treatment experimental: gait, balance, arm function, cognition
Sponsor Malcom Randall VA Medical Center
Start date May 2012
End date October 2017
Trial size 24 participants
Trial identifier NCT01158781, PT074749


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(No Intervention)
This group will receive no study related interventions.
12 weeks of training for balance, gait, upper limb function, and cognition
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

Primary Outcomes

Quality of Life
time frame: Week 12

Secondary Outcomes

cognitive function
time frame: week 12
arm function
time frame: week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Restoration of Life Role Participation Through Integrated Cognitive and Motor Training for Individuals With TBI
Principal investigator Janis Daly, Ph.D., M.S.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Malcom Randall VA Medical Center.