Effects of a Metronome on Functional Outcomes in Aquatic Therapy

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.

Study Overview

• Status: Completed
• Conditions: Exercise Therapy
• Intervention / Treatment: Device: Metronome

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canton, Ohio, United States, 44708
      • Aultman Tusc Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metronome; This arm will be using the metronome as a pacing device during aquatic exercises.	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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Aultman Health Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hydrotherapy; Aquatic Therapy; Pool Therapy
• Other Study ID Numbers: AultmanRA2018.10.AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No