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The primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion.
This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Flow Restriction Group | Experimental |
|
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| Non-Blood Flow Restriction Group | Active Comparator | This group will perform the same exercises for the same volume without the use of BFR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Therapy | Other | Exercise with Blood Flow Restriction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Return to Play | Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer. | From Time of Injury to 8 weeks after Injury |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level | Pain will be assessed with the Visual Analog Pain Scale (VAS). The minimum and maximum scores are 0 and 10 respectively with higher scores meaning a worse outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit |
| Range of Motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VUMC | Nashville | Tennessee | 37232 | United States |
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The assessors will not be aware of group allocation.
| Standard Physical Therapy |
| Other |
Exercise without Blood Flow Restriction |
|
Range of motion of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 360 with higher scores meaning a worse outcome. |
| Initial visit & 1, 2, 4, and 8 weeks after the initial visit |
| Strength Testing | Strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 5 with higher scores meaning a better outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit |
| The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score | The Foot and Ankle Ability Measure (FAAM) will be used to measure self-reported physical function. It will be measured from 0 to 116 with higher scores meaning a better outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit |
| Foot and Ankle Outcome Score (FAOS) Patient-Reported Score | The Foot and Ankle Outcome Score (FAOS) will be used to measure self-reported physical function. It will be measured from 0 to 100% with higher scores meaning a better outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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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 |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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