Aquatic Exercise and Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957421
• Other study ID #: 5/14/2019 Stroke
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: January 11, 2020

Study information

• Verified date: October 2023
• Source: Methodist University, North Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 11, 2020
• Est. primary completion date: January 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• aquatic exercise, land based exercise
general warm up and cool down. general exercises and treadmill training at self-selected intensity.

Locations

Country	Name	City	State
United States	Methodist Universtiy	Fayetteville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Methodist University, North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Romberg	Balance test with standing feet together eyes open and eyes closed for up to 30 seconds on 3 trials	12 weeks.
Secondary	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
Secondary	Single limb stance	balance test with standing on one leg for up to 30 seconds bilaterally for a total of 3 trails	12 weeks
Secondary	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
Secondary	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.