Aquatic Exercise and Stroke

NCT ID: NCT03957421

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2020-01-11

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aquatic exercise is more beneficial than land based exercise

use of aquatic exercise will be evaluated for individuals with stroke

Group Type: EXPERIMENTAL

aquatic exercise, land based exercise

Intervention Type: OTHER

general warm up and cool down. general exercises and treadmill training at self-selected intensity.

Interventions

aquatic exercise, land based exercise

general warm up and cool down. general exercises and treadmill training at self-selected intensity.

Intervention Type: OTHER

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

• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Methodist University, North Carolina

OTHER

Sponsor Role: lead

Responsible Party

Stacia Hall

Assistant Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Methodist Universtiy

Fayetteville, North Carolina, United States

Countries

United States

Other Identifiers

5/14/2019 Stroke

Identifier Type: -

Identifier Source: org_study_id