N/A
Completed N=5
Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients
Walking Aided by a Leg Brace in Stroke Subjects
Source: ClinicalTrials.gov NCT02122783 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Self-selected Walking Velocity — 0.71; 0.74 m/s
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-selected Walking Velocity |
0.71; 0.74 | — |
| PRIMARY Step Length Symmetry |
0.98; 0.96 | — |
| PRIMARY Step Time Symmetry |
1.03; 0.99 | — |
| SECONDARY Joint Kinematics |
— | — |
| SECONDARY Joint Kinetics |
— | — |
| SECONDARY Activity (Step Count) |
— | — |
| SECONDARY Subject Opinions |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02122783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.