Walking Aided by a Leg Brace in Stroke Subjects Clinical Trial
Official title:
Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients
| NCT number | NCT02122783 |
| Other study ID # | HN 4422 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | January 30, 2020 |
| Verified date | September 2021 |
| Source | Albert Einstein Healthcare Network |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | January 30, 2020 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | MossRehab | Elkins Park | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Albert Einstein Healthcare Network |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self-selected Walking Velocity | walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat) | 8 weeks | |
| Primary | Step Length Symmetry | 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). | 8 weeks | |
| Primary | Step Time Symmetry | 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). | 8 weeks | |
| Secondary | Joint Kinematics | joint kinematics will be assessed using motion capture system | 8 weeks | |
| Secondary | Joint Kinetics | joint kinematics will be assessed using motion capture and biomechanical force measurement systems | 8 weeks | |
| Secondary | Activity (Step Count) | activity will be measured using accelerometer based step activity monitoring devices | 8 weeks | |
| Secondary | Subject Opinions | subject opinions will be measured using surveys and questionnaires | 8 weeks |