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Low recruitment and end of funding for study.
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| Name | Class |
|---|---|
| HeadStrong Foundation | UNKNOWN |
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The purpose of this study is to determine whether a course of daily manual lymphatic drainage over the course of 5 days can improve lymphatic drainage function and cognitive outcomes and to determine whether single sessions of manual lymphatic drainage improves lymphatic drainage in moderate to severe traumatic brain injury (TBI) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Lymphatic Drainage (MLD) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Lymphatic Drainage (MLD) | Other | The participant will be placed in a supine position and manual lymphatic drainage will be performed for 50 minutes. During the three intervening days, daily 50 minute sessions of manual lymphatic drainage will be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage | 2 NIRF-LI sessions will be conducted separated by 3 days. | day 1, day 5 |
| change in cognitive test results as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global health( GH) scale | Nine of the 10 PROMIS GH items are scored on a Likert scale from 1 to 5, with 5 representing the best health. Pain which is the 10th question is scored from 0(no pain) to 10(worst imaginable pain). | day1,day2,day3,day4,day5 |
| change in cognitive test results as assessed by the Patient Health Questionnaire-9 (PHQ-9) | This scale consists of a set of 9 questions each scored form 0(not at all) to 3 (nearly every day), a higher score indicating a worse outcome. Total score ranges form 0-27. | day1,day2,day3,day4,day5 |
| change in cognitive test results as assessed by the Multilingual Aphasia Examination III-Controlled Oral Word Association | This is used to asses phonemic fluency. Participant is asked to name words that begin with a particular letter in one minute and examiner will write down the words said by the participant. This will be reported y the number of words participants say in one minute | day1,day2,day3,day4,day5 |
| change in cognitive test results as assessed by the Trail Making Test(TMT) | Scores are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. | day1,day2,day3,day4,day5 |
| change in cognitive test results as assessed by the learning trial |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIRF-LI detected lymphatic drainage | response of NIRF-LI detected lymphatic drainage in response to manual lymphatic drainage by imaging drainage before and after manual lymphatic drainage | day1,day5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Sevick, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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This will be assessed by the number of words participants can remember |
| day1,day2,day3,day4,day5 |
| change in cognitive test results as assessed by the delayed recall trial instructions | This will be assessed by the number of words participants can remember after 20-25 minutes delay | day1,day2,day3,day4,day5 |
| change in cognitive test results as assessed by the Semantic Category learning trial | There are 12 words that participants will categories as Four-legged Animals, precious stones and human dwellings for a total score from 0-12 a higher number indicates a better outcome | day1,day2,day3,day4,day5 |
| Change in processing speed, as assessed by the Wechsler Adult Intelligence Scale -IV | Two subtests from the Wechsler Adult Intelligence Scale - IV are used (Coding and Symbol Search). Age-adjusted standard scores are calculated for each of subtest. The 2 subtest scores are then combined to create the Processing Speed Index. Processing Speed Index will be reported as a percentile (0% to 100%), with a higher percentile indicating a better outcome | day1,day2,day3,day4,day5 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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