Amputation StumpsNCT02921295
A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis
A study testing Sidekick Stubbies in people with Amputation Stumps, run by Angela DeCandia at 1 site in United States.
Trial summary
The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation Stumps
- What is being tested?
- Sidekick Stubbies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral transfemoral amputee
- own a pair of conventional stubby prosthesis with standard adaptation
Who cannot join
- dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)
- use of prosthesis that do not allow change of feet with standard adapters
- any medical condition that may put an individual in greater risk of injury than normal daily activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bakery Square MSPO labs
Pittsburgh, Pennsylvania, 15206
About this study
The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.
- Conditions
- Amputation Stumps
- Being tested
- Sidekick Stubbies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sidekick StubbiesDevice
| Study group | Role | What they receive |
|---|---|---|
| Sidekick Stubbies | Active comparator | Conventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses ("Sidekick" manufactured by College Park Ind.) were used as intervention Receives: Device: Sidekick Stubbies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Speed for 10 Meter Walk Test
The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.
Measured: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
Secondary outcomes (2)
Timed up and go Test Time
The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.
Measured: 6 times throughout study completion (3 every 1 hour during the 2 hour protocol)
Gait Symmetry Index
Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.
Measured: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amputation StumpsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela DeCandia
- Sponsor type
- University, hospital or other
- Collaborators
- College Park Industries
- Responsible party
- Sponsor-investigator, Angela DeCandia, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921295
- Sponsor's protocol ID
- PRO16050355
- Status last verified
- Apr 2018
- First submitted
- 29 Sep 2016
- Last updated
- 21 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis
- ClinicalTrials.gov ID
- NCT02921295
- Acronym / sponsor ID
- PRO16050355
- Conditions
- Amputation Stumps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Angela DeCandiaUniversity, hospital or other
- Collaborators
- College Park Industries
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Posted 24 May 2018
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 study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sidekick Stubbies | Active comparator | Device: Sidekick StubbiesConventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses ("Sidekick" manufactured by College Park Ind.) were used as intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral transfemoral amputee
- own a pair of conventional stubby prosthesis with standard adaptation
Key exclusion criteria (3 listed)
- dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)
- use of prosthesis that do not allow change of feet with standard adapters
- any medical condition that may put an individual in greater risk of injury than normal daily activity.
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 |
|---|---|---|
| Sidekick Stubbies | Device | Sidekick Stubbies |
Primary outcome
Average Speed for 10 Meter Walk Test
Time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.
2 secondary outcomes
Timed up and go Test Time
Time frame: 6 times throughout study completion (3 every 1 hour during the 2 hour protocol)
Gait Symmetry Index
Time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Amputation Stumps
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Not yet recruitingObservational study
Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
Residual Limb Pain, Stump Pain
Not yet recruitingObservational study
Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain
Amputation Stump, Amputation Neuroma
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 Sidekick Stubbies in people with Amputation Stumps, run by Angela DeCandia 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 3 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 21 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 24 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Speed for 10 Meter Walk Test (time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)). 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 21 Jun 2018; AzTrials last refreshed its copy on 4 Nov 2026.