The Analysis and Applications of Dynamic Impression Insole
NCT01629173 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2012-06-27
Summary
The aim of the study was to investigate the effectiveness of dynamic impression insoles on plantar pressure and pain reduction. A dynamic impression insole was made by sequential padding with Plastazote and P-cell under daily walking compression. The pain levels and plantar pressure with the use of dynamic impression insole were assessed and compared with 7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was assessed using a Visual Analog Scales.
Conditions
- Metatarsalgia
Interventions
- PROCEDURE
-
Dynamic impression insole
We sequentially padded (1)a 6.5-mm thick P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), and (2)a piece of metatarsal pad and arch support made of Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) to the bottom of the impressed 9-mm thick plastazote (15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) with double-sided adhesive tape in the forefoot region and just proximal to the first, second, and third metatarsal head region. We additionally padded a 2-mm thick Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the top of the impressed insole with double-sided adhesive tape.
- PROCEDURE
-
Custom molded insole
The custom molded insole was made by sequentially padded Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), Ethylene Vinyl Acetate (EVA)(40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), and cork (50 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the positive plaster cast impressed by an impression box while holding the subtalar joint at a neutral position.
- PROCEDURE
-
9-mm uncompressed Plastazote
We used 9-mm flat Plastazote(15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
- PROCEDURE
-
7-mm Ethylene Vinyl Acetate (EVA)
We used 7-mm flat Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
Sponsors & Collaborators
-
Taipei Veterans General Hospital, Taiwan
lead OTHER_GOV
Principal Investigators
-
Chang Bao-Chi · Taipei Veterans General Hospital, Taiwan
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- Taiwan
Study Locations
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