StrokeNCT03957421
Aquatic Exercise and Stroke
A study testing aquatic exercise, land based exercise in people with Stroke, run by Methodist University, North Carolina at 1 site in United States.
Trial summary
To determine the impact of underwater vs. land based exercise and/or gait training on functional mobility for patients with stroke. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- aquatic exercise, land based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2019to 11 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stroke
- Able to walk 20 meters without a lower extremity orthotic.
Who cannot join
- Significant fear of water
- Seizures
- Incontinence with bowel or bladder
- Open wounds
- Infections such as UTI or fever
- Tracheostomy, nasogastric or gastronomy tube
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Universtiy
Fayetteville, North Carolina, 28311
About this study
Official title: Underwater Activity Compared to Land-based Activity for Individuals With Stroke
To determine the impact of underwater vs. land based exercise and/or gait training on functional mobility for patients with stroke.
Read the 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
- Being tested
- aquatic exercise, land based exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic exercise, land based exerciseOther
general warm up and cool down. general exercises and treadmill training at self-selected intensity.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic exercise is more beneficial than land based exercise | Experimental | use of aquatic exercise will be evaluated for individuals with stroke Receives: Other: aquatic exercise, land based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
Romberg
Balance test with standing feet together eyes open and eyes closed for up to 30 seconds on 3 trials
Measured: 12 weeks.
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
Measured: 12 weeks
Single limb stance
balance test with standing on one leg for up to 30 seconds bilaterally for a total of 3 trails
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start11 Jan 2019
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist University, North Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacia Hall, Methodist University, North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957421
- Sponsor's protocol ID
- 5/14/2019 Stroke
- Status last verified
- Oct 2023
- First submitted
- 14 May 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Activity Compared to Land-based Activity for Individuals With Stroke
- ClinicalTrials.gov ID
- NCT03957421
- Acronym / sponsor ID
- 5/14/2019 Stroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Methodist University, North CarolinaUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercise is more beneficial than land based exercise | Experimental | Other: aquatic exercise, land based exerciseuse of aquatic exercise will be evaluated for individuals with stroke |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke
- Able to walk 20 meters without a lower extremity orthotic.
Key exclusion criteria (15 listed)
- Significant fear of water
- Seizures
- Incontinence with bowel or bladder
- Open wounds
- Infections such as UTI or fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aquatic exercise, land based exercisegeneral warm up and cool down. general exercises and treadmill training at self-selected intensity. | Other | Aquatic exercise is more beneficial than land based exercise |
Primary outcome
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.
5 secondary outcomes
Romberg
Time frame: 12 weeks.
Sharpened Romberg
Time frame: 12 weeks
Single limb stance
Time frame: 12 weeks
4-square step test
Time frame: 12 weeks
Timed Up and Go
Time frame: 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic exercise, land based exercise in people with Stroke, run by Methodist University, North Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.