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Completed

NCT Number: NCT03957421

Aquatic Exercise and Stroke

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

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Key information

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Universtiy

Fayetteville, North Carolina, 28311, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aquatic exercise, land based exercise

Other

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

Primary outcomes

  1. Dynamic Gait Index

    Time frame: 12 weeks

    8 item gait and balance measure looking at fall risk. participants are scored on a 0-3 scale. 19/24 indicates fall risk.

Secondary outcomes

  1. Romberg

    Time frame: 12 weeks.

    Balance test with standing feet together eyes open and eyes closed for up to 30 seconds on 3 trials

  2. Sharpened Romberg

    Time frame: 12 weeks

    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

  3. Single limb stance

    Time frame: 12 weeks

    balance test with standing on one leg for up to 30 seconds bilaterally for a total of 3 trails

  4. 4-square step test

    Time frame: 12 weeks

    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.

  5. Timed Up and Go

    Time frame: 12 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Methodist University, North Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 21, 2019
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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