Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01175993 | Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury | PHASE1 | COMPLETED | 34 | — | — | Aug 24, 2011 | Feb 4, 2014 | Jun 1, 2026 | 1 | United States |
Primary outcomes are Hi-MAT score, reaction time during balance testing and the Hamilton Rating Scale for Depression (Ham-D).
| Arm | Type | Description |
|---|---|---|
| Eliptical training | ACTIVE_COMPARATOR | Home base exercise |
| Name | Type | Description |
|---|---|---|
| Elliptical exercise | OTHER | Each participant with TBI will participate in an exercise intervention which will be done in the home. The exercise device in this protocol will be an elliptical trainer that requires coordinated reciprocal movements of both the legs and the arms. Primary emphasis will be placed on maintaining a near maximal speed of movement and to progressively increase this over time. Mild resistance to the leg motion will be provided initially and will be progressively increased once speed and coordination are optimized. The device will be loaned to them to use in the home, and will be delivered to the home fully assembled. Participants will be monitored by phone the first week and thereafter every two weeks and progressed as indicated. The exercise program will be performed 5 days a week for 30 minutes per session, for a total duration of 12 weeks. All will record the length, speed and resistance of each session on a paper-based log sheet. |
* INLCUSION CRITERIA: Inclusion criteria for all subjects (healthy volunteers and those with TBI) include: -ages 18 - 44, inclusive Additional inclusion criteria for those with TBI include:diagnosis of traumatic brain injury * at least 6 months from initial brain injury * ability to stand and wa...