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CompletedNCT01336517Updated Apr 18, 2011

Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function

An observational study in Hemiplegia, Spastic, sponsored by Kessler Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-04-18.

Sponsored by Kessler Foundation · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

Read the detailed description

To comprehensively evaluate the effect of an AFO on ambulatory function and loading in hemiplegic gait. This study is addressing important questions regarding the effect of an AFO on gait and introduces technology for quantifiable objective assessment of AFO effectiveness. It will attempt to identify if AFO wear compliance increases community ambulation and walking efficiency bilaterally. Research is needed to fully understand how compliance affects mobility outcomes.

02

Conditions studied

  • Hemiplegia, Spastic

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Keywords

  • Stroke
  • Hemiplegia
  • AFO
  • Gait
03

In context

Hemiplegia

374 studies on the registry are indexed under Hemiplegia; 83 are open to participants now.

This study's enrollment of 20 is below the median of 51 across 56 observational studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and 75, who are greater than 6 months post and have been prescribed a custom molded AFO for assistance with gait deviations

Inclusion criteria

  • Between the ages of 18 and 75
  • Have sustained a stroke at least 6 months prior to study enrollment
  • Use a prescribed custom brace while walking
  • Have no history of injury, orthopedic or other medical problem in the normal leg
  • Be able to walk independently or with close supervision for 25 feet without a brace or cane
  • Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens

Exclusion criteria

Exclusion Criteria:

  • Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
  • Neurological illness, history, or conditions that my interfere with walking except for stroke
  • Psychiatric conditions or history that would interfere with the ability to walk or follow directions
  • Serious lung or heart condition that could severely limit the ability to walk
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
06

Study locations

1 site
  • Kessler Foundation Research Center
    West Orange, New Jersey 07052, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01336517
Lead sponsor
Kessler Foundation
First posted
Apr 18, 2011
Start date
Aug 2007
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Apr 18, 2011

Study contacts

Karen Nolan, Ph.D.
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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