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WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

2014-08-27 03:15:11 | BioPortfolio

Summary

The purpose of this clinical trial is to establish equivalence or incremental benefit of the Walkaide device to standard of care Ankle Foot Orthosis (AFO) for patients with foot drop due to stroke.

Description

This is an un-blinded, randomized, parallel group, controlled trial with a group-sequential design and a single interim analysis. The purpose of this study is to compare the performance of the WalkAide device with Functional Electrical Stimulation (FES) versus Ankle-Foot Orthosis (AFO) in patients with sub-acute and chronic stroke.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stroke

Intervention

WalkAide, Ankle-Foot Orthosis (AFO)

Location

St. Mary's of Michigan
Saginaw
Michigan
United States
44195

Status

Recruiting

Source

Innovative Neurotronics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:11-0400

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PubMed Articles [2577 Associated PubMed Articles listed on BioPortfolio]

The effects of an articulated ankle-foot orthosis with resistance-adjustable joints on lower limb joint kinematics and kinetics during gait in individuals post-stroke.

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Medical and Biotech [MESH] Definitions

Entrapment of the distal branches of the posterior TIBIAL NERVE (which divides into the medial plantar, lateral plantar, and calcanial nerves) in the tarsal tunnel, which lies posterior to the internal malleolus and beneath the retinaculum of the flexor muscles of the foot. Symptoms include ankle pain radiating into the foot which tends to be aggravated by walking. Examination may reveal Tinel's sign (radiating pain following nerve percussion) over the tibial nerve at the ankle, weakness and atrophy of the small foot muscles, or loss of sensation in the foot. (From Foot Ankle 1990;11(1):47-52)

The articulations extending from the ANKLE distally to the TOES. These include the ANKLE JOINT; TARSAL JOINTS; METATARSOPHALANGEAL JOINT; and TOE JOINT.

Deformity in which the foot is misaligned with respect to the TALUS in the ANKLE JOINT. While mostly congenital, as in CLUBFOOT, acquired deformities are included. Acquired talipedes are often associated with other foot deformities such as SYNDACTYLY and POLYDACTYLY.

The region of the lower limb between the FOOT and the LEG.

Harm or hurt to the ankle or ankle joint usually inflicted by an external source.

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