Restoration of Life Role Participation Through Cognitive and Motor Training for TBI
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 26, 2019
March 1, 2019
5.4 years
October 13, 2009
March 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Berg Balance
Balance function
week 12
Study Arms (1)
gait, balance, arm function, cognition
EXPERIMENTAL12 weeks of training for balance, gait, upper limb function, and cognition
Interventions
12 weeks of training for balance, gait, upper limb function, and cognition, including functional electrical stimulation with surface electrodes, robotics, and motor learning
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pacemaker
- Acute medical conditions
- potential subjects will undergo a screening evaluation to determine eligibility for study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gainesville VA Medical Center
Gainesville, Florida, 32608, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janis Daly, Ph.D., M.S.
US Department of Veterans Affairs
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Brain Rehabilitation Research Center
Study Record Dates
First Submitted
October 13, 2009
First Posted
July 8, 2010
Study Start
May 1, 2012
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 26, 2019
Record last verified: 2019-03