Efficacy of the Diabetes Prevention Program Group Lifestyle Balance Program Modified for Individuals with TBI (GLB-TBI): Results from a 12-month Randomized Controlled Trial.

BACKGROUND: Obesity after traumatic brain injury (TBI) is a public health issue and no evidence-based weight loss interventions exist to meet the unique needs of individuals after TBI. PURPOSE: To (a) examine the efficacy of the Diabetes Prevention Program Group Lifestyle Balance for TBI (GLB-TBI) weight-loss intervention compared to an attention control for primary (weight-loss) and secondary health outcomes; (b) determine participant compliance with the GLB-TBI; and (c) determine if compliance is associated with improved outcomes. METHODS: Individuals with moderate to severe TBI, age 18-64 years, ≥6 months postinjury, and body mass index of ≥25 kg/m2 were randomized to a 12-month, 22-session GLB-TBI intervention or attention control condition. Weight-loss (lbs.), anthropometric, biomarkers, and patient-reported outcomes were collected at baseline, 3, 6, and 12 months. RESULTS: The GLB-TBI group (n = 27) lost 17.8 ± 41.4lbs (7.9%) over the 12-month program and the attention control group (n = 27) lost 0 ± 55.4lbs (0%). The GLB-TBI group had significant improvements in diastolic blood pressure, triglycerides, and HDL cholesterol. GLB-TBI attendance was 89.6% and weekly self-monitoring of diet and activity was 68.8%. Relative to baseline, the GLB-TBI compliant group (≥80% attendance; ≥85% self-monitoring; n = 10) had a statistically significant decrease in weight at each assessment, the noncompliant group had a significant decrease between 6 and 12 months (n = 17), with no change in weight in the attention control group (n = 27). CONCLUSIONS: Findings suggest for adults with TBI who are overweight or obese, participation in the GLB-TBI can significantly reduce weight and metabolic risk factors and increase self-reported habits for diet and exercise.

Foundational ingredients of robotic gait training for people with incomplete spinal cord injury during inpatient rehabilitation (FIRST): A randomized controlled trial protocol.

INTRODUCTION: As technological advances allow the use of robotic exoskeleton devices with gait training, there is a critical need to establish a robotic gait training (RGT) program to meet the needs of people with spinal cord injury (SCI) during inpatient rehabilitation. The purposes of this study are to prospectively examine the efficacy of a stakeholder informed RGT program compared to usual care gait training (UC) during inpatient rehabilitation in people with incomplete SCI and compare the intensity of RGT and UC gait training during inpatient rehabilitation. STUDY DESIGN: 128 patients with incomplete SCI admitted to our inpatient rehabilitation facility will be screened for eligibility and randomized to either the RGT or UC group. RGT sessions will use the Ekso robotic exoskeleton [class II medical device (United States FDA)]. UC sessions will use traditional gait training approaches such as manually assisted overground gait training with walkers and orthotics and body weight-supported treadmill training (BWSTT). Our primary outcome is gait function as characterized by the Walking Index for Spinal Cord Injury-II (WISCI-II). Secondary outcomes are gait speed, Spinal Cord Independence Measure (SCIM), Numeric Pain Rating Scale (NPRS), Fatigue Severity Scale (FSS), Penn Spasm Frequency Scale (PSFS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder- 7 (GAD-7), International Spinal Cord Injury Quality of Life Basic Data Set, and a Qualitative Questionnaire. Assessments of primary and secondary outcomes will occur at admission and discharge from inpatient rehabilitation. General or generalized linear models will be used to analyze differences between groups for all measures. CLINICAL IMPACT: Successful completion of this study will provide a usable, replicable, stakeholder informed RGT intervention for use with individuals with incomplete SCI during inpatient rehabilitation.