Traumatic Brain Injury Clinical Trial
Official title:
Effect of High-Intensity Gait Training Using a Treadmill on Locomotion Recovery in Traumatic Brain Injury Patients
Verified date | April 2024 |
Source | Carilion Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The project will consist of subjects who have suffered Traumatic Brain Injury (TBI) and who are able to ambulate on treadmill with or without a harness system. This will be a 4-week controlled study consisting of two groups of TBI patients, high-intensity intervention group and low-intensity control group. Both groups will receive physical therapy treatment 3 times per week for 1 hour. The intervention group will undergo 30-minute sessions of high-intensity walking on a treadmill with an overhead harness attached for safety. In addition, they will also get up to 30-minutes of low-intensity physical therapy in order to receive 1 hour of treatment time. The control group will undergo only low-intensity physical therapy activities for 1-hour. Low-intensity physical therapy will include strength exercises, stretches, balance, and low-intensity gait training. All participants in both groups will complete these outcome measures on the first day of the study, after 2 weeks of participation, and again at the end of 4 weeks or on their last day before discharge from Carilion's services. Later on, all participants in both groups will be followed up to complete the same set of outcome measures at the end of 1 month since completion of the protocol. This follow up session will take up to 45 minutes to complete.
Status | Terminated |
Enrollment | 11 |
Est. completion date | June 15, 2023 |
Est. primary completion date | June 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Medical and treadmill screening clearance to participate in this study - Persons with mild, moderate, or severe Traumatic Brain Injury at onset (first time or repeats) - 18-65 years old persons who are able to ambulate on treadmill with or without assistive devices and with or without need for bodyweight-support harness system - Ability to communicate with investigators to follow protocol instructions and respond appropriately - Patients who have decision-making capacity and are able to consent for themselves Exclusion Criteria: - Unstable orthopedic conditions, for example, unstable craniectomies or weight-bearing restrictions. - Unstable cardiac conditions including, unstable angina, unstable cardiac dysrhythmias, myocardial ischemia or hypertension at rest (systolic BP > 140mm Hg and diastolic BP >90 mm Hg, or if over this range, then a physician must clear patient for participation) - Acute systemic infection accompanied by fever, body aches or swollen lymph glands. - Hospitalization for acute cardiac, pulmonary or metabolic conditions in the past 3 months. - Any other physical or mental restrictions preventing participation in the research protocol. - Women who are pregnant are being excluded as this is considered a high risk study. They will be asked via verbal questioning via the following statements, "Are you currently pregnant?" or "Are you planning to become pregnant?". - Non-English Speakers |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Orthopaedics and Neurosciences | Roanoke | Virginia |
Lead Sponsor | Collaborator |
---|---|
Carilion Clinic | Radford University, Virginia Polytechnic Institute and State University |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Five Times Sit to Stand Test | Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. | |
Primary | Six Minute Walk Test (6MWT) | a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. | |
Primary | 10 Meter Walk Test (10mWT) | Assesses walking speed in meters/second (m/s) over a short distance. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. | |
Primary | Berg Balance Scale (BBS) | Used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The minimum value of this assessment is 0, and the maximum is 56. A higher score means a better outcome. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. | |
Primary | Timed Up and Go (TUG) | Assesses a person's mobility that requires both static and dynamic balance. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. | |
Primary | Timed Up and Go (Cognitive) | Complete a TUG test while counting backward by three from a randomly selected number between 20 and 100. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. | |
Primary | Montreal Cognitive Assessment (MoCA) | A rapid screening instrument for mild cognitive dysfunction. The minimum value of this assessment is 0, and the maximum is 30. A higher score means a better outcome. | Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up. |
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