Trial · NCT07182578
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | World Health Organization Quality of Life - Brief (WHOQOL-BREF) | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention | The WHOQOL-BREF is a 26-item questionnaire that will be completed digitally. It is scored by first assigning numerical values (1-5) to each response, with higher scores generally indicating a better quality of life. Then, raw domain scores are calculated by averaging the responses within each domain (Physical, Psychological, Social, and Environmental). Finally, these raw domain scores are transformed into scaled scores ranging from 0 to 100 by multiplying by 4. Higher scores on the 0-100 scale indicate a higher quality of life. The measure will be reported as a quality of life score. |
| Primary | The DePaul Symptom Questionnaire (Short Form) (DSQ-SF) | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention. | 14-item-questionnaire which measures post-exertional malaise symptoms over the last 6 months. Each question requires two ratings, one for frequency (0 = none of the time and 4 = all of the time) and one for severity (0 = symptom not present and 4 = very severe). A frequency of at least 2 and a severity of at least 2 on any one of the 5 questions on the DSQ-SF subscale indicate that post exertional malaise is present. For each symptom, the frequency and severity scores are averaged, and then multiplied by 25 to create a composite score out of 100. The measure will be reported as a post exertional malaise score. |
| Primary | Composite Autonomic Symptom Score-31 | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention. | Measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance \[10 points\]; vasomotor \[6 points\]; secretomotor \[7 points\]; gastrointestinal \[28 points\]; bladder \[9 points\] and pupillomotor \[15 points\]. A higher score indicates worse autonomic dysfunction. Simple yes or no questions are scored as 0 points for no and 1 point for yes. Questions about a specific site of symptoms or symptoms under specific circumstances are scored as 0 if not present and as 1 if present for each site or circumstance. All questions regarding the frequency of symptoms were scored as 0 points for rarely or never, 1 point for occasionally or sometimes, 2 points for frequently or "a lot of the time," and 3 points for almost always or constantly. All questions regarding the severity of symptoms were scored as 1 point for mild, 2 points for moderate, and 3 points for severe. The measure will be reported as a COMPASS score |
| Primary | Malmo POTS Scale (MAPS) | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention | This 12-item questionnaire assesses the specific POTS symptom burden over the past 3 months. Each question uses a visual analog scale from 0-10, with a maximum score of 120. A score of 42 or higher is considered indicative of POTS. The measure will be reported as a MAPS score. |
| Primary | ADLS, IADLS, and Vestibular Questionnaire | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention | This is a 26-item questionnaire that will be filled out digitally. 21 questions cover about to participate in occupations listed in the Occupational Therapy Practice Framework using a scale from 1-10, where 1 is unable to complete the task, 5 is able to complete task with moderate difficulty (noticeable symptoms and extra effort is required) 10 is no problems/symptoms completing the task. It also contains 5 vestibular related questions using a scale from 1-7, with 1 being not at all dizzy, 4 being moderately dizzy, and 7 being extremely dizzy. The measure will be reported as an AIVQ score. |
| Primary | Active Stand Test | From enrollment until the end of treatment at 12 weeks | The patient will begin laying down in a relaxed and comfortable position. Blood pressure (BP) and heart rate (HR) are taken after 5 minutes. Next, the patient will be asked to stand promptly, and will have their BP and HR measured immediately. The therapist will note any comments like "feeling dizzy". The BP and HR will be taken again and documented after three minutes, and again after ten minutes of standing. If there is any event, such as severe dizziness, paleness, etc, the BP and HR will be taken and documented just before the patient sits down. The measure will be reported as the position, time, and the correlated heart rate and blood pressure. |
| Primary | Single leg stance test | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention | This test measures a person's ability to balance standing on one leg without assistance. The participant will stand on one leg with their hands on their hips while being timed. The test is repeated 3 times for each leg and averaged. The measure will be reported as time standing per leg. |
| Primary | Heart Rate | From enrollment to the end of treatment at 12 weeks | Heart rate (HR) will be measured on land while the participant is laying down, sitting up, and standing. HR in the water will be taken while seated and standing. An aquatic HR maximum and HR zones will be calculated for each participant. This measure will be reported as a land-based and aquatic HR maximum. |
| Primary | Borg's rate of perceived exertion scale | From enrollment to the end of treatment at 12 weeks | This scale is used to tell how tiring an activity feels. The scale ranges from 6 (no exertion at all), to 20 (maximal heaviness). This will be reported as the RPE score. |
| Secondary | The Stroop Test | From enrollment to the end of 12 weeks of aquatic occupational therapy intervention | The Stroop Test is a measure of working memory and attention. A participant is asked to read words of various colors, say the color of the letters when they are the same, and when the colors don't match the words. They are timed and errors are tracked. This will be reported as the SCWT score. |
| Secondary | Trail Making Test Parts A & B | From enrollment to the end of the intervention at 12 weeks | The participant is given a paper with numbers and letters, and is instructed to connect the letters and numbers in order (1-A-2-B-3-C, etc.), as quickly as possible, without lifting the pend or pencil from the paper. Errors will be pointed out immediately and the participant is allowed to correct it, but the time it takes to correct is still included in the completion time for the task. This will be reported as the TMT-A and TMT-B scores. |
| Secondary | Enrollment | From enrollment to the end of treatment at 12 weeks | Total number of participants who complete the informed consent, evaluation session, and agree to participate in program according to schedule discussed with participant |
| Secondary | Attrition Rate | From enrollment to the end of treatment at 12 weeks | The number of enrolled participants who do not complete the program |
| Secondary | Session attendance rate | From enrollment to the end of treatment at 12 weeks | This will be calculated by the number of sessions attended out of the total number of sessions for the program. |
| Secondary | Cost analysis | From enrollment to the end of treatment at 12 weeks | This measure will include resource tracking and total costs divided by the number of completers. |
| Secondary | Health utilization changes | From enrollment to the end of treatment at 12 weeks | This will include a calculation of health utilization changes from before the program compared to after the program |
| Secondary | Satisfaction Analysis | From enrollment to the end of treatment at 12 weeks | Thematic analysis of open-ended feedback from participants and stakeholders will determine the most common themes and areas for improvement within the program. |
| Secondary | Exercise self-efficacy | From enrollment to the end of treatment at 12 weeks | Measure will be completed before the program and compared to the result after, leading to an ESE score. |
| Secondary | Goal Attainment Scaling | From enrollment to the end of treatment at 12 weeks | Goal attainment scaling is a method to turn individualized goals into a 5-point evaluation method, using a score of -2 to + 2 to quantify progress towards the specific goals. It measures the outcomes against expected results, where 0 is the expected outcome, -2 is much less than the expected outcome, and +2 is much more than the expected outcome. |
| Secondary | Beighton Score | From enrollment to the end of treatment at 12 weeks | The Beighton score is a screener for hypermobility and can be done quickly and simply with no testing materials needed. It consists of a 5-point scale, requires 5 maneuvers. It involves the evaluation of only a small number of joints, so any hypermobile joints not in this group may be overlooked. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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