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| Sponsor: | Dynasplint Systems, Inc. |
|---|---|
| Information provided by: | Dynasplint Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT00650884 |
Purpose
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).
| Condition | Intervention |
|---|---|
|
Plantar Fasciitis |
Device: Ankle Dorsiflexion Dynasplint System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study |
| Estimated Enrollment: | 66 |
| Study Start Date: | February 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CONTROL PATIENTS will only be treated with Standard of Care during this 12 week trial, but will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch after completion of this study.
|
Device: Ankle Dorsiflexion Dynasplint System
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.
Other Name: Cross-Over
|
|
Experimental: 2
ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). EXPERIMENTAL PATIENTS will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.
|
Device: Ankle Dorsiflexion Dynasplint System
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.
Other Name: Cross-Over
|
|
3
ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CROSS-OVER patients will be initially treated only with Standard of Care, and after six weeks, they will be Crossed-Over and fit with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.
|
Device: Ankle Dorsiflexion Dynasplint System
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.
Other Name: Cross-Over
|
To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Kaiser Permanente | |
| Sacramento, California, United States, 95825 | |
| United States, Florida | |
| Orlando Foot & Ankle Center | |
| Orlando, Florida, United States | |
| United States, Georgia | |
| Ankle & Foot Centers, PC | |
| Marietta, Georgia, United States, 30066 | |
| United States, Texas | |
| Lopez Foot Ankle Clinic | |
| Ft Worth, Texas, United States, 76164 | |
| Study Chair: | Dr Mathew M John, DPM | Ankle & Foot Centers, PC |
| Study Director: | Buck Willis, PhD | Dynasplint Systems, Inc. |
More Information
| Responsible Party: | Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT00650884 History of Changes |
| Other Study ID Numbers: | Dynasplint, DYN1-08-022 |
| Study First Received: | March 31, 2008 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Dynamic Splinting for low-load, prolonged-duration stretch |
|
Fasciitis Fasciitis, Plantar Musculoskeletal Diseases Foot Diseases |