AmputationNCT06259695
Development and Usability of an Adjustable Prosthesis for Aquatic Therapy
A study testing Adjustable Aquatic Therapy Prosthesis in people with Amputation, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy. Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation
- What is being tested?
- Adjustable Aquatic Therapy Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-89 years
- Patients who have a unilateral transtibial amputation who are able to use a prosthesis
- Patients who currently participate in aquatic therapy at Shirley Ryan AbilityLab, or have completed aquatic therapy within the last six months, at Shirley Ryan AbilityLab
Who cannot join
- Pregnant women
- Children (<18 years old)
- Prisoners or institutionalized individuals
- Individuals who have the inability to give informed consent
- Participants with complicating health conditions that interfere with the study
- Participants with contraindications to aquatic therapy, as listed in Shirley Ryan AbilityLab's policy on aquatic therapy participation
Trial locations and contacts
1 site in 1 country.
About this study
The initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy. Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss. The pool environment offloads body weight, which can improve comfort on a residual limb and increase confidence in activities outside of the pool. The properties of water also assist in strengthening exercises and reducing pain.
Currently, most individuals do not have a prosthesis to use in the pool. Water specific prosthesis are often not covered by insurance and can be expensive. For someone that doesn't have a water specific prosthesis, they may not be able to do therapy tasks on two legs, limiting what activities or exercises can be performed. Through creating an adjustable prosthesis, it will allow persons with limb loss to have access to a water specific leg in a time efficient, cost effective, and safe manner for rehabilitation.
This study involves a novel prosthesis for use in aquatic therapy. This novel design will have an adjustable circumference, residual limb length, and height, allowing a greater number of patients to use the prosthesis.
Read the detailed description
The goal of this project is to create and conduct a preliminary usability evaluation of a novel adjustable prosthesis for use in aquatic therapy for persons with a lower limb amputation at the transtibial level (LLTTA). It is hypothesized that this prosthesis will benefit both the patient and the therapist during aquatic therapy sessions, which will be evaluated through the following aims:
Aim 1: Create a non-custom, adjustable prosthesis for use in aquatic therapy by individuals with limb loss at the transtibial level.
Aim 2: Perform a pilot study (n=3) to quantity the usability of the prosthesis as a therapy tool.
- Conditions
- Amputation
- Being tested
- Adjustable Aquatic Therapy Prosthesis
- Keywords
- Aquatic Therapy, Limb Loss, Limb Difference, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Aquatic Therapy ProsthesisDevice
We will recruit up to three participants, who will attend up to two fitting appointments lasting up to one hour to assist in the design development. After the design of the prosthesis is completed, participants will attend three, 30-minute, aquatic therapy sessions with a physical therapist trained in aquatic therapy and utilize the prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Adjustable Aquatic Therapy Prosthesis | Experimental | The prosthesis will be designed to be adjustable in circumference, residual limb length, and overall height. This will allow adjustability to accommodate most limb shapes. The design will also provide secure suspension, on both land and in the water. This will maximize safety for the patient and translate motion from the residual limb to the prosthesis. Additionally, the prosthesis design will include a comfortable fit and interface, protecting the participant's skin. Skin will be assessed prior to use, during initial fitting, and after each therapy session. Finally, the prosthesis will be test fit and used with maximum assistance from clinical staff, minimizing risk. Receives: Device: Adjustable Aquatic Therapy Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Survey - Subject
The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: Through study completion, an average of one year.
Secondary outcomes (2)
Socket Comfort Score
Rating system to assess prosthesis socket comfort. Scale ranges from 0-10, with 0 being the least comfortable and 10 the most comfortable.
Measured: Through study completion, an average of one year.
System Usability Survey - Physical Therapist
The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: Through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start23 Aug 2023
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Miller, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259695
- Sponsor's protocol ID
- STU00219525
- Status last verified
- May 2025
- First submitted
- 30 Jan 2024
- Last updated
- 6 May 2025
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Usability of an Adjustable Prosthesis for Aquatic Therapy
- ClinicalTrials.gov ID
- NCT06259695
- Acronym / sponsor ID
- STU00219525
- Conditions
- Amputation
- Keywords
- Aquatic Therapy, Limb Loss, Limb Difference, Prosthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Feb 2024 (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.
The initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy. Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss. The pool environment offloads body weight, which can improve comfort on a residual limb and increase confidence in activities outside of the pool. The properties of water also assist in strengthening exercises and reducing pain.
Currently, most individuals do not have a prosthesis to use in the pool. Water specific prosthesis are often not covered by insurance and can be expensive. For someone that doesn't have a water specific prosthesis, they may not be able to do therapy tasks on two legs, limiting what activities or exercises can be performed. Through creating an adjustable prosthesis, it will allow persons with limb loss to have access to a water specific leg in a time efficient, cost effective, and safe manner for rehabilitation.
This study involves a novel prosthesis for use in aquatic therapy. This novel design will have an adjustable circumference, residual limb length, and height, allowing a greater number of patients to use the prosthesis.
Detailed description
The goal of this project is to create and conduct a preliminary usability evaluation of a novel adjustable prosthesis for use in aquatic therapy for persons with a lower limb amputation at the transtibial level (LLTTA). It is hypothesized that this prosthesis will benefit both the patient and the therapist during aquatic therapy sessions, which will be evaluated through the following aims:
Aim 1: Create a non-custom, adjustable prosthesis for use in aquatic therapy by individuals with limb loss at the transtibial level.
Aim 2: Perform a pilot study (n=3) to quantity the usability of the prosthesis as a therapy tool.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjustable Aquatic Therapy Prosthesis | Experimental | Device: Adjustable Aquatic Therapy ProsthesisThe prosthesis will be designed to be adjustable in circumference, residual limb length, and overall height. This will allow adjustability to accommodate most limb shapes. The design will also provide secure suspension, on both land and in the water. This will maximize safety for the patient and translate motion from the residual limb to the prosthesis. Additionally, the prosthesis design will include a comfortable fit and interface, protecting the participant's skin. Skin will be assessed prior to use, during initial fitting, and after each therapy session. Finally, the prosthesis will be test fit and used with maximum assistance from clinical staff, minimizing risk. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-89 years
- Patients who have a unilateral transtibial amputation who are able to use a prosthesis
- Patients who currently participate in aquatic therapy at Shirley Ryan AbilityLab, or have completed aquatic therapy within the last six months, at Shirley Ryan AbilityLab
Key exclusion criteria (6 listed)
- Pregnant women
- Children (<18 years old)
- Prisoners or institutionalized individuals
- Individuals who have the inability to give informed consent
- Participants with complicating health conditions that interfere with the study
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 |
|---|---|---|
| Adjustable Aquatic Therapy ProsthesisWe will recruit up to three participants, who will attend up to two fitting appointments lasting up to one hour to assist in the design development. After the design of the prosthesis is completed, participants will attend three, 30-minute, aquatic therapy sessions with a physical therapist trained in aquatic therapy and utilize the prosthesis. | Device | Adjustable Aquatic Therapy Prosthesis |
Primary outcome
System Usability Survey - Subject
Time frame: Through study completion, an average of one year.
The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
2 secondary outcomes
Socket Comfort Score
Time frame: Through study completion, an average of one year.
System Usability Survey - Physical Therapist
Time frame: Through study completion, an average of one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- 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 Adjustable Aquatic Therapy Prosthesis in people with Amputation, run by Shirley Ryan AbilityLab 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
System Usability Survey - Subject (time frame: Through study completion, an average of one year.). 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 6 May 2025.