Effects of a Metronome on Functional Outcomes in Aquatic Therapy

NCT03801772 | Completed

• 1 other identifier: AultmanRA2018.10.AF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Therapy

Keywords

Aquatic Therapy; Hydrotherapy; Pool Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level.

  Initial evaluation and up to 8 weeks

• Global Rating of Change

  Up to 8 weeks

Study Arms (2)

Metronome

ACTIVE COMPARATOR

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

Device: Metronome

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

Interventions

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.

Metronome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women who identify themselves as pregnant on the clinics intake sheet.
• Anyone unable to hear the beats of the metronome.

Sponsors & Collaborators

• Aultman Health Foundation: lead

Study Sites (1)

Aultman Tusc Therapy

Canton, Ohio, 44708, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist Assistant

Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: January 21, 2019
• Primary Completion: December 31, 2019
• Study Completion: April 16, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)