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| Name | Class |
|---|---|
| Southern Connecticut State University | UNKNOWN |
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Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment. Measurements will be taken to determine how the exo-skeletons affect the pressure on the feet of people with diabetic foot ulcer and how they walk.
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will include those with self-described history of Diabetic Foot Ulcer and age-matched healthy volunteers. Participants will wear the exo-skeletons and will be asked to walk 32 feet, and to stand quietly for 30 seconds.
Measurements will be taken to evaluate how the exoskeletons affect how people walk, and will also evaluate the pressure on the bottom of their feet. These measurements will be repeated multiple times to evaluate four different exo-tendon spring rates, and two sets of control shoes.
Exo-skeletons have been shown to reduce the pressure on the bottoms of people's feet and to reduce the effort to walk. This study is necessary to understand the contribution of different levels of exo-skeleton spring force to these effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Arm | Experimental | Participants will be used as their own controls. Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon. Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton | Device | Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forefoot plantar pressure | Measurements of the force and pressure on the bottom of the front of the foot | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of fall risk | Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos | Los Angeles | California | 90242 | United States | ||
| Southern CT State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28859516 | Background | Roser MC, Canavan PK, Najafi B, Cooper Watchman M, Vaishnav K, Armstrong DG. Novel In-Shoe Exoskeleton for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology. J Diabetes Sci Technol. 2017 Sep;11(5):874-882. doi: 10.1177/1932296817726349. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Participants will be evaluated as their own controls.
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| New Haven |
| Connecticut |
| 06515 |
| United States |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |