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Completed

NCT Number: NCT03801772

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.

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Key information

Conditions

Exercise Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aultman Tusc Therapy

Canton, Ohio, 44708, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aultman Health Foundation

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jan 11, 2019
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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