Effects of a Metronome on Functional Outcomes in Aquatic Therapy

Exercise Therapy Clinical Trial

Official title:

Effects of a Metronome on Functional Outcomes in Aquatic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801772
• Other study ID #: AultmanRA2018.10.AF
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: April 16, 2021

Study information

• Verified date: September 2021
• Source: Aultman Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 16, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients over the age of 18 assigned to aquatic therapy

Exclusion Criteria:

• Women who identify themselves as pregnant on the clinics intake sheet.

• Anyone unable to hear the beats of the metronome.

Related Conditions & MeSH terms

• Exercise Therapy

Intervention

Device:
• Metronome
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.

Locations

Country	Name	City	State
United States	Aultman Tusc Therapy	Canton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Aultman Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Global Rating of Change	Patient rates their improvement compared to the start of treatment from (-)7 [very much worse] to (+)7 [ completely recovered with "0" (zero) being unchanged.	Up to 8 weeks