Clinical trial NCT03957421: Aquatic Exercise and Stroke
Official title: Underwater Activity Compared to Land-based Activity for Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Methodist University, North Carolina
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 3
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Romberg
timeFrame: 12 weeks.
measure: Sharpened Romberg
timeFrame: 12 weeks
measure: Single limb stance
timeFrame: 12 weeks
measure: 4-square step test
timeFrame: 12 weeks
measure: Timed Up and Go
timeFrame: 12 weeks.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Methodist Universtiy
state: North Carolina
Study officials:
References: