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

NCT ID: NCT02122783

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2020-01-30

Brief Summary

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.

Detailed Description

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.

Conditions

Walking Aided by a Leg Brace in Stroke Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Conventional then Experimental brace resistance

Participants received the Default intervention for a period of a month, were evaluated in the lab and then the novel intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention.

Group Type: EXPERIMENTAL

ADR™ brace resistance

Intervention Type: DEVICE

Conventional brace resistance (using hard stops)

Intervention Type: DEVICE

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

Experimental then Conventional brace resistance

Participants received the the novel elastomer to provide brace support intervention for a period of a month, were evaluated in the lab and then the conventional intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention.

Group Type: EXPERIMENTAL

ADR™ brace resistance

Intervention Type: DEVICE

Conventional brace resistance (using hard stops)

Intervention Type: DEVICE

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

Interventions

ADR™ brace resistance

Intervention Type: DEVICE

Conventional brace resistance (using hard stops)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 21 and 70 males and non-pregnant females

2. Diagnosis of stroke more than 1 year ago

3. Ambulatory at 0.5m/s or greater

4. Require unilateral AFOs to ambulate

5. Stable medical condition - no concomitant progressive diseases that could affect motor function

6. Ability to comply with directions and cooperate with research team

Exclusion Criteria

1. Subjects who are currently receiving physical therapy for gait problems

2. Anticipated surgical or pharmacologic intervention for tone/contractures during the study period

3. 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)

4. Recent cardiac or active pulmonary disease, liable blood pressure

5. Recent back surgery

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Mukul Talaty

Biomechanist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mukul Talaty, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein (MossRehab)

Locations

MossRehab

Elkins Park, Pennsylvania, United States

Countries

United States

Other Identifiers

HN 4422

Identifier Type: -

Identifier Source: org_study_id