Effects of a Metronome on Functional Outcomes in Aquatic Therapy

NCT ID: NCT03801772

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2021-04-16

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants are assigned to one of two or more groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.

Study Groups

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Metronome

This arm will be using the metronome as a pacing device during aquatic exercises.

Group Type ACTIVE_COMPARATOR

Metronome

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aultman Health Foundation

OTHER

Sponsor Role lead

Responsible Party

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Dan Fomich

Physical Therapist Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aultman Tusc Therapy

Canton, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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AultmanRA2018.10.AF

Identifier Type: -

Identifier Source: org_study_id

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