Aquatic Exercise and Stroke

Underwater Activity Compared to Land-based Activity for Individuals With Stroke

To determine the impact of underwater vs. land based exercise and/or gait training on functional mobility for patients with stroke.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: aquatic exercise, land based exercise

Detailed Description

Subjects will be recruited via convenience sampling from the Methodist University community and local area. Additionally contacts from medical clinics may be contacted for recruitment of participants. Once individuals have been identified, they will be informed of inclusion and exclusion criteria to be assessed for appropriateness for the project. Informed consent will be provided to participants prior to start.

Inclusion criteria consists of having a stroke and being able to walk 20 meters without a lower extremity orthotic. If participant's have significant fear of water, seizures, incontinence with bowel or bladder, open wounds, infections such as UTI or fever, tracheostomy, nasogastric or gastronomy tube, colostomy, uncontrolled hypertension, skin rash, hard cast due to fracture, isolation precautions, IV or indwelling catheters, uncontrolled agitation, require use of continuous supplemental oxygen, or allergies to chemicals used in a pool, they will not be placed in the underwater groups.

Demographic survey will be provided and filled out prior to the start of data collection.

As physical therapy exercise is within the scope of Physical Therapy Practice and in the state of North Carolina Physical Therapists have direct access to practice without a physician clearance, participants will be assessed using baseline testing (please see below) to ensure medical stability for participation in exercise. Furthermore, participants will be asked if they have been cleared by a physician prior to beginning in exercise (please see consent survey). If individuals evaluated by the supervising physical therapist are deemed to need additional medical clearance from their physician, they will be asked to attain a note from the physician stating they are clear to participate in exercise.

Baseline testing: Participants will complete a basic physical therapy examination consisting of vitals assessment (heart rate, blood pressure, oxygen saturation, rate of perceived exertion and respiratory rate), anthropometric measurements, posture, range of motion, strength testing and use of the following outcome measures to assess self-perception of stroke impact, balance and gait: 4-square step test (FSST), Timed Up and Go (TUG), Dynamic Gait Index (DGI), Romberg, Sharpened Romberg and Single Limb Stance (SLS). Additionally, gait characteristics will be measured using the GAITRite System.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Fayetteville, North Carolina, United States, 28311
      • Methodist Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Stroke
• Able to walk 20 meters without a lower extremity orthotic.

Exclusion Criteria:

• Significant fear of water
• Seizures
• Incontinence with bowel or bladder
• Open wounds
• Infections such as UTI or fever
• Tracheostomy, nasogastric or gastronomy tube
• Colostomy
• Uncontrolled hypertension
• Skin rash
• Hard cast due to fracture
• Isolation precautions
• IV or indwelling catheters
• Uncontrolled agitation
• Require use of continuous supplemental oxygen
• Allergies to chemicals used in a pool

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aquatic exercise is more beneficial than land based exercise; use of aquatic exercise will be evaluated for individuals with stroke	Other: aquatic exercise, land based exercise; general warm up and cool down. general exercises and treadmill training at self-selected intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Gait Index	8 item gait and balance measure looking at fall risk. participants are scored on a 0-3 scale. 19/24 indicates fall risk.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Romberg	Balance test with standing feet together eyes open and eyes closed for up to 30 seconds on 3 trials	12 weeks.
Sharpened Romberg	Balance test with standing feet one in front of the other eyes open and eyes closed for up to 30 seconds on 3 trials. repeated with each foot in front	12 weeks
Single limb stance	balance test with standing on one leg for up to 30 seconds bilaterally for a total of 3 trails	12 weeks
4-square step test	balance test looking at the ability to walk in a square with stepping over obstacles and changing directions. participants are timed for how fast they can place each foot in each square and back for 1 round. greater than 15 seconds indicates fall risk.	12 weeks
Timed Up and Go	Balance test for functional mobility. person starts sitting in a chair, when instructed person stands, walks 10 feet turns around, walks back to the chair and sits down. person is timed for 2 trials. second trial is scored.	12 weeks.

Collaborators and Investigators

• Sponsor: Methodist University, North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): January 11, 2020
• Study Completion (Actual): January 11, 2020

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 5/14/2019 Stroke

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