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Effects of a Metronome on Functional Outcomes in Aquatic Therapy

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ClinicalTrials.gov Identifier: NCT03801772
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Fomich, Aultman Health Foundation

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.

Condition or disease Intervention/treatment Phase
Exercise Therapy Device: Metronome Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.
Primary Purpose: Treatment
Official Title: Effects of a Metronome on Functional Outcomes in Aquatic Therapy
Estimated Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801772


Contacts
Contact: Andrew D Fomich, Bachelor 330-363-6215 Dan.Fomich@aultman.com

Sponsors and Collaborators
Aultman Health Foundation
  Study Documents (Full-Text)

Documents provided by Dan Fomich, Aultman Health Foundation:
Study Protocol  [PDF] November 14, 2018


Responsible Party: Dan Fomich, Physical Therapist Assistant, Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT03801772     History of Changes
Other Study ID Numbers: AultmanRA2018.10.AF
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dan Fomich, Aultman Health Foundation:
Aquatic Therapy
Hydrotherapy
Pool Therapy