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Aquatic Exercise and Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aquatic exercise, land based exercise
Sponsored by
Methodist University, North Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Methodist Universtiy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aquatic exercise is more beneficial than land based exercise

Arm Description

use of aquatic exercise will be evaluated for individuals with stroke

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Romberg
Balance test with standing feet together eyes open and eyes closed for up to 30 seconds on 3 trials
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
Single limb stance
balance test with standing on one leg for up to 30 seconds bilaterally for a total of 3 trails
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.
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.

Full Information

First Posted
May 14, 2019
Last Updated
October 18, 2023
Sponsor
Methodist University, North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03957421
Brief Title
Aquatic Exercise and Stroke
Official Title
Underwater Activity Compared to Land-based Activity for Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
January 11, 2020 (Actual)
Study Completion Date
January 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Methodist University, North Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic exercise is more beneficial than land based exercise
Arm Type
Experimental
Arm Description
use of aquatic exercise will be evaluated for individuals with stroke
Intervention Type
Other
Intervention Name(s)
aquatic exercise, land based exercise
Intervention Description
general warm up and cool down. general exercises and treadmill training at self-selected intensity.
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Description
8 item gait and balance measure looking at fall risk. participants are scored on a 0-3 scale. 19/24 indicates fall risk.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Romberg
Description
Balance test with standing feet together eyes open and eyes closed for up to 30 seconds on 3 trials
Time Frame
12 weeks.
Title
Sharpened Romberg
Description
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
Time Frame
12 weeks
Title
Single limb stance
Description
balance test with standing on one leg for up to 30 seconds bilaterally for a total of 3 trails
Time Frame
12 weeks
Title
4-square step test
Description
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.
Time Frame
12 weeks
Title
Timed Up and Go
Description
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.
Time Frame
12 weeks.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Methodist Universtiy
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28311
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Aquatic Exercise and Stroke

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