Amputation Stumps Clinical Trial
Verified date | April 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | April 28, 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - bilateral transfemoral amputee - own a pair of conventional stubby prosthesis with standard adaptation Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Bakery Square MSPO labs | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Angela DeCandia | College Park Industries |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 times throughout study completion (every 1 hour during the 2 hour protocol) | |
Secondary | 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. | 6 times throughout study completion (3 every 1 hour during the 2 hour protocol) | |
Secondary | 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. | 2 times throughout study completion (every 1 hour during the 2 hour protocol) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01632709 -
Pathophysiology of Post Amputation Pain
|
Phase 4 | |
Completed |
NCT01645722 -
Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites
|
N/A | |
Completed |
NCT04427007 -
Moisture Management Liner Effectiveness Study
|
N/A | |
Withdrawn |
NCT02883751 -
Phototherapy in DM Amputation Ulcers.
|
N/A | |
Completed |
NCT00126126 -
Evidence Based Amputee Rehabilitation (EBAR) Program
|
N/A | |
Completed |
NCT00592098 -
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
|
Phase 2 | |
Completed |
NCT02115360 -
Epidural Calcitonin in Lower Limb Amputation
|
N/A | |
Completed |
NCT02128451 -
The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine
|
Phase 4 |