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Completed

NCT Number: NCT02122783

Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients

The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

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Key information

Conditions

Walking Aided by a Leg Brace in Stroke Subjects

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MossRehab

Elkins Park, Pennsylvania, 19027, United States

About this study

The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. Participants undergo testing in the gaitlab after using the new brace for a period of time. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 21 and 70 males and non-pregnant females
  • Diagnosis of stroke more than 1 year ago
  • Ambulatory at 0.5m/s or greater
  • Require unilateral AFOs to ambulate
  • Stable medical condition - no concomitant progressive diseases that could affect motor function
  • Ability to comply with directions and cooperate with research team

Exclusion criteria

  • Subjects who are currently receiving physical therapy for gait problems
  • Anticipated surgical or pharmacologic intervention for tone/contractures during the study period
  • Additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures)
  • Recent cardiac or active pulmonary disease, liable blood pressure
  • Recent back surgery

Treatment and study plan

ADR™ brace resistance

Device

Conventional brace resistance (using hard stops)

Device

Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs

Primary outcomes

  1. Self-selected Walking Velocity

    Time frame: 8 weeks

    walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)

  2. Step Length Symmetry

    Time frame: 8 weeks

    step length symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step length on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, meters to meters).

  3. Step Time Symmetry

    Time frame: 8 weeks

    step time symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step time on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, seconds to seconds).

Secondary outcomes

  1. Joint Kinematics

    Time frame: 8 weeks

    joint kinematics will be assessed using motion capture system

  2. Joint Kinetics

    Time frame: 8 weeks

    joint kinematics will be assessed using motion capture and biomechanical force measurement systems

  3. Activity (Step Count)

    Time frame: 8 weeks

    activity will be measured using accelerometer based step activity monitoring devices

  4. Subject Opinions

    Time frame: 8 weeks

    subject opinions will be measured using surveys and questionnaires

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Registry information

Official study title

Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2020
First posted
Apr 25, 2014
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.