Effects of a Metronome on Functional Outcomes in Aquatic Therapy
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|ClinicalTrials.gov Identifier: NCT03801772|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Exercise Therapy||Device: Metronome||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||participants are assigned to one of two or more groups in parallel for the duration of the study|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.|
|Official Title:||Effects of a Metronome on Functional Outcomes in Aquatic Therapy|
|Estimated Study Start Date :||January 7, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Metronome
This arm will be using the metronome as a pacing device during aquatic exercises.
Pacing aquatic exercises to the beats per minute of a metronome. The metronome will be adjusted to each patient's pain free exertion level. Patients will start with 10-20 repetitions of the exercises depending on their physical ability. The repetitions will be progressed as the patient's strength and endurance improve and noted in the chart and the flow sheet. The metronome will be synchronized during their second aquatic therapy treatment. The beats per minute (BPM) will be increased on the metronome during the series of treatments until the patient can no longer maintain proper technique with the exercises. The exercises will continue at this BPM during future visits. The patient will be instructed to keep pace with the beat of the metronome for the duration of the exercise.
No Intervention: Control
The patients will be educated on proper performance of aquatic exercises following normal physical therapy procedures. Patients will start with 10-20 repetitions of the exercises depending on their physical ability and progressed as the patient's strength and endurance improve. Each session will last approximately 30 to 45 minutes. The BORG scale (a valid, subjective measure of perceived exertion) will be used as a monitoring device to ensure that a desired level of exercise intensity is reached. The desired level is a score between 12 and 16. The patients will be asked to rate their level of exertion at the end of each session. Intensity of the exercises will be adjusted the next session if the patient's reported level of exertion does not fall within the desired range. The pain rating and the BORG number will be recorded for both groups in the chart and flow
- Change between initial 30 second sit to stand measure and final measurement [ Time Frame: Initial evaluation and up to 8 weeks ]Patient stands and sits as many times as they can in 30 seconds. The number of repetitions is recorded.
- Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level. [ Time Frame: Initial evaluation and up to 8 weeks ]Pain level is reported on a 0 -10 scale with 0 being no pain and 10 being the highest level of pain.
- Global Rating of Change [ Time Frame: Up to 8 weeks ]Patient rates their improvement compared to the start of treatment from (-)7 [very much worse] to (+)7 [ completely recovered with "0" (zero) being unchanged.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801772
|Contact: Andrew D Fomich, Bachelor||330-363-6215||Dan.Fomich@aultman.com|