Amputation Balance ProsthesisNCT04657614
The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees
A study testing Neutral Alignment, Anterior Alignment and Posterior Alignment in people with Amputation Balance Prosthesis, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance, heart rate and fit during sit to stands. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation Balance Prosthesis
- What is being tested?
- Neutral Alignment, Anterior Alignment and Posterior Alignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 8 Jul 2021
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female below knee amputees (bi-lateral or unilateral)
- 18-70 years of age
- K1-K3 (K-levels/activity levels)
- K1=patient has the ability or potential to use a prosthesis for transfers or walking on level surfaces at a fixed speed (typical limited or unlimited household ambulator).
- K2=patient has the ability or potential for walking with the ability to traverse most low-level environmental barriers such as curbs, stairs, or uneven surfaces (typical community ambulator).
- K3=patient has the ability or potential for walking with variable speed. Has the ability to traverse most environmental barriers and may have vocational, exercise, or recreational activities that demand prosthetic use beyond simple locomotion.
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- Those who wear a prosthesis daily for the purpose of walking
- Able to get in and out of a chair
- Prosthetic foot that has the same functional components as the subject's current one
Who cannot join
- Amputation at birth
- Foot amputation at ankle
- Uncontrolled edema in leg compartments
- Compromised skin of the residual limb
- Patients that are 3 months or less post-amputation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance, heart rate and fit during sit to stands.
Read the detailed description
Initial Visit:
- Informed consent
- HIPAA
- Foot Inspection
- Review expectations
- Take measurements
- Casting
Second Visit: Fitting and adjusting accordingly.
- One person will conduct all the measurements, casting, check sockets, etc. to evade inconsistencies in data collection.
- Begin conducting practice runs on Balance Master at LLU-East Campus.
Third, Fourth and Fifth Visit: Testing (5-10-minute rest period in between each test) *Testing will be video recorded for re-assessment of subjects*
- Five times sit-to-stand test (5XSTS).
- Activities-Specific Balance Confidence (ABC-16) scale
- Balance Master: Weight Bearing Squat (WBS) Unilateral Stance (US) Sensory Organization Test (SOT) modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Limits of Stability (LOS)
- A Polar H10 heart rate monitor will be worn while subjects perform each of the various tests.
- Conditions
- Amputation Balance Prosthesis
- Being tested
- Neutral Alignment, Anterior Alignment, Posterior Alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral AlignmentOther
Alignment that is a neutral replicate of the participants prescribed prosthesis.
Anterior AlignmentOther
Alignment that is anterior displaced pylon.
Posterior AlignmentOther
Alignment that is posteriorly displaced pylon.
| Study group | Role | What they receive |
|---|---|---|
| Neutral Alignment Group | Experimental | A straight pylon with the ankle at neutral. Receives: Other: Neutral Alignment |
| Anterior Alignment Group | Experimental | An anteriorly displaced pylon with ankle dorsiflexion at 5 degrees. Receives: Other: Anterior Alignment |
| Posterior Alignment Group | Experimental | A posteriorly displaced pylon with 5 degrees of plantarflexion at the ankle. Receives: Other: Posterior Alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 Time Sit to Stand Test
The sit to stand test will be administered five times uninterrupted. The participants will sit in a chair and stand up preferably unassisted by researchers. They will be timed.
Measured: three weeks
Secondary outcomes (2)
Activities-Specific Balance Confidence Questionnaire
Measure of balance and confidence in performing various activities.
Measured: three weeks
Balance test
Smart Balance Master system will be used to measure balance and prosthetic alignment during balance test such as limits of stability and weight bearing squat.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start17 Mar 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation Balance ProsthesisStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Davidson, Loma Linda University
- Investigators
- Michael Davidson, MSE MPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657614
- Sponsor's protocol ID
- 5200455
- Status last verified
- Jul 2021
- First submitted
- 1 Dec 2020
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees
- ClinicalTrials.gov ID
- NCT04657614
- Acronym / sponsor ID
- 5200455
- Conditions
- Amputation Balance Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 8 Dec 2020 (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 purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance, heart rate and fit during sit to stands.
Detailed description
Initial Visit:
- Informed consent
- HIPAA
- Foot Inspection
- Review expectations
- Take measurements
- Casting
Second Visit: Fitting and adjusting accordingly.
- One person will conduct all the measurements, casting, check sockets, etc. to evade inconsistencies in data collection.
- Begin conducting practice runs on Balance Master at LLU-East Campus.
Third, Fourth and Fifth Visit: Testing (5-10-minute rest period in between each test) *Testing will be video recorded for re-assessment of subjects*
- Five times sit-to-stand test (5XSTS).
- Activities-Specific Balance Confidence (ABC-16) scale
- Balance Master: Weight Bearing Squat (WBS) Unilateral Stance (US) Sensory Organization Test (SOT) modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Limits of Stability (LOS)
- A Polar H10 heart rate monitor will be worn while subjects perform each of the various tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral Alignment Group | Experimental | Other: Neutral AlignmentA straight pylon with the ankle at neutral. |
| Anterior Alignment Group | Experimental | Other: Anterior AlignmentAn anteriorly displaced pylon with ankle dorsiflexion at 5 degrees. |
| Posterior Alignment Group | Experimental | Other: Posterior AlignmentA posteriorly displaced pylon with 5 degrees of plantarflexion at the ankle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and Female below knee amputees (bi-lateral or unilateral)
- 18-70 years of age
- K1-K3 (K-levels/activity levels)
- Those who wear a prosthesis daily for the purpose of walking
- Able to get in and out of a chair
Key exclusion criteria (5 listed)
- Amputation at birth
- Foot amputation at ankle
- Uncontrolled edema in leg compartments
- Compromised skin of the residual limb
- Patients that are 3 months or less post-amputation
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 |
|---|---|---|
| Neutral AlignmentAlignment that is a neutral replicate of the participants prescribed prosthesis. | Other | Neutral Alignment Group |
| Anterior AlignmentAlignment that is anterior displaced pylon. | Other | Anterior Alignment Group |
| Posterior AlignmentAlignment that is posteriorly displaced pylon. | Other | Posterior Alignment Group |
Primary outcome
5 Time Sit to Stand Test
Time frame: three weeks
The sit to stand test will be administered five times uninterrupted. The participants will sit in a chair and stand up preferably unassisted by researchers. They will be timed.
2 secondary outcomes
Activities-Specific Balance Confidence Questionnaire
Time frame: three weeks
Balance test
Time frame: three 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 12 Jul 2021.
Related trials for Amputation Balance Prosthesis
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Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
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Automatic Prosthetic Foot Stiffness Modulation to Improve Balance in the Real World
Lower Limb Amputation Below Knee
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Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis
Transfemoral Amputation, Balance Impairment
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Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Lower Limb Amputation, Prosthesis Users
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Restoration of Normative Postural Control
Lower Limb Amputation Below Knee (Injury)
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.
Michael Davidson, MSE MPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral Alignment, Anterior Alignment and Posterior Alignment in people with Amputation Balance Prosthesis, run by Loma Linda University 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 9 inclusion and 5 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 12 Jul 2021. 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?
5 Time Sit to Stand Test (time frame: three 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 12 Jul 2021.