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Principal Investigator left institution and not enough resources to support at MTF
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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
| Telemedicine & Advanced Technology Research Center | OTHER |
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The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional self-report, and objective functional measures. SWE will be utilized to objectively quantify tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles tendinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFR Group | Experimental | Blood Flow Restriction Training with Eccentric Exercise Protocol |
|
| Sham BFR Group | Sham Comparator | Sham Blood Flow Restriction Training with Eccentric Exercise Protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Training | Other | Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shear Wave Elastography velocity | Difference between involved and uninvolved Achilles tendon | At baseline. |
| VISA-A | Change in subjective self-report of Achilles function | From baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triple hop test | Distance in length of 3 consecutive hops on one foot | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. |
| SL Calf Raise Endurance | Number of single leg calf raises to failure |
| Measure | Description | Time Frame |
|---|---|---|
| Blinding/Group assignment assessment | Question asking which group they believe they are in (interventional vs control) | At 12 weeks and 24 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A Whitehurst, DPT | Womack Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Army Medical Center | Fort Bragg | North Carolina | 28310 | United States |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
| Sham Blood Flow Restriction Training | Other | Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment. |
|
| Eccentric Exercise | Other | Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily. |
|
| At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. |
| SL Jump Height | Distance in height of single leg jump | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. |
| Thigh Circumference | circumferential measurement of thigh | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. |
| Calf Circumference | circumferential measurement of calf | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. |
| Numerical Pain Rating Scale | Pain level on a 0 to 10 scale | At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. |
| Global Rating of Change | 15 point Likert scale from -7 to +7 | At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. |
| Shear Wave Elastography velocity | Change in shear wave elastography of symptomatic Achilles tendon over time. | Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks. |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |