Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gait Perturbations to Improve Balance Post-stroke

NCT04314830

Hemiparesis;Poststroke/CVA

COMPLETED NA

The Use of Brace to Retrain Hemiparetic Gait

NCT02082938

Stroke Nos Without Residual Deficits

COMPLETED NA

Retraining the Walking Pattern After Stroke

NCT03813342

Stroke Hemiparesis

COMPLETED NA

Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.

NCT02693834

Stroke CVA Hemiplegia +2 more

COMPLETED NA

Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

NCT06109194

Hemiparesis;Poststroke/CVA

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Gait, Hemiplegic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stroke

People who have had a stroke and have an ankle-foot orthosis.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* be over the age of 18;
* have the presence of hemiplegia after stroke;
* be wearing an ankle-foot orthosis for at least 6 weeks;
* be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (AFOs, canes and walkers);
* be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
* be able to reach criterion on the attention task (described below)
* be competent to give informed consent as determined by clinical team and noted in the health chart

Exclusion Criteria

* have history of balance deficits not related to stroke;
* be at high risk of falling during the study;
* suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the Montreal Cognitive Assessment (MoCA) test.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No