42
Participants
Start Date
September 30, 2016
Primary Completion Date
January 31, 2018
Study Completion Date
April 24, 2019
Constraint-Induced Movement Therapy (CIMT)
Constraint-Induced Movement Therapy (CIMT) is a form of physical rehabilitation based on basic research in behavioral psychology and behavioral neuroscience. The therapy will be given on an outpatient basis for 3.5 hours/day for 10 consecutive weekdays. This treatment has four components: 1. intensive training in use of the more-affected arm; 2. organization of this training following shaping principles, which involve frequent positive feedback and progressively increasing the demand of the task in small increments; 3. discouraging use of the less-affected arm by placing the hand in a padded safety mitt, and 4. a set of behavioral procedures, known as the Transfer Package, for transferring gains from the treatment to real-world setting. In this study, two forms of the Transfer Package, standard and enhanced, will be used and form a separate factor (see below).
Lakeshore Enriched Fitness Training (LEFT)
This treatment will given on an outpatient basis for 3.5 hours per day for 10 consecutive weekdays. It will consist of the following components: general fitness exercises (largely lower extremity), sports and recreation (land and water-based); adapted Yoga; breathing exercises and postural control, movement to music, massage therapy, meditation and Progressive Muscle Relaxation (PMR).
standard Transfer Package (sTP)
This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. The sTP is a set of behavioral procedures for transferring gains from the treatment setting to real-world. The procedures when the sTP is applied to CIMT include negotiating a behavioral contract with the patient and caregiver, when available, about use of each arm during the treatment period, keeping a daily diary on arm use, completing a structured interview about use of the more-affected arm in daily, problem solving about perceived barriers to use of the more-affected arm outside the treatment setting during treatment, and four weekly follow-up phone calls to assess use of the more-affected arm and problem solve about any remaining barriers perceived to its use. The sTP when applied to the LEFT intervention will have parallel components that target engagement in fitness activities and overcoming perceived barriers to fitness in the home.
enhanced Transfer Package (eTP)
This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. It is an enhanced form of the sTP. The enhancements include a computerized version of the daily diary, cues to be placed in patients' homes to prompt engagement in desired activities, and additional follow-up phone calls.
University of Alabama at Birmingham, Birmingham
United States Department of Defense
FED
University of Alabama at Birmingham
OTHER