Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if the use of a pacing device, a metronome, improves functional outcome measures in aquatic therapy when compared to a control group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronome | Active Comparator | This arm will be using the metronome as a pacing device during aquatic exercises. |
|
| Control | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronome | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change between initial 30 second sit to stand measure and final measurement | Patient stands and sits as many times as they can in 30 seconds. The number of repetitions is recorded. | Initial evaluation and up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level. | Pain level is reported on a 0 -10 scale with 0 being no pain and 10 being the highest level of pain. | Initial evaluation and up to 8 weeks |
| Global Rating of Change |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aultman Tusc Therapy | Canton | Ohio | 44708 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2018 | Jan 15, 2019 | Prot_001.pdf |
Not provided
participants are assigned to one of two or more groups in parallel for the duration of the study
Not provided
Not provided
Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.
|
Patient rates their improvement compared to the start of treatment from (-)7 [very much worse] to (+)7 [ completely recovered with "0" (zero) being unchanged.](streamdown:incomplete-link) |
| Up to 8 weeks |