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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional then Experimental brace resistance | Experimental | 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. |
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| Experimental then Conventional brace resistance | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADR™ brace resistance | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Self-selected Walking Velocity | walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat) | 8 weeks |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Joint Kinematics | joint kinematics will be assessed using motion capture system | 8 weeks |
| Joint Kinetics | joint kinematics will be assessed using motion capture and biomechanical force measurement systems |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mukul Talaty, PhD | Albert Einstein (MossRehab) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MossRehab | Elkins Park | Pennsylvania | 19027 | United States |
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This is a cross over study - so all participants received both interventions (i.e. were in both study arms).
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Then Experimental Brace Resistance | Default intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs Experimental intervention Same MAFO but with ADR (soft polymer) providing brace resistance |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
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| 8 weeks |
| Activity (Step Count) | activity will be measured using accelerometer based step activity monitoring devices | 8 weeks |
| Subject Opinions | subject opinions will be measured using surveys and questionnaires | 8 weeks |
| Experimental Then Conventional Brace Resistance |
Experimental Condition Using the novel elastomer (ADR™ ) to provide brace resistance Conventional Condition Same MAFO as above but using pins/springs to provide brace resistance |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Then Experimental Brace Resistance | Conventional intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs Experimental intervention Same MAFO as above but now using ADR™ soft polymer as brace resistance |
| BG001 | Experimental Then Conventional Brace Resistance | Experimental intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing ADR™ soft polymer as brace resistance Conventional intervention Same MAFO as above but now using springs/pins as brace resistance |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-selected Walking Velocity | walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat) | Posted | Mean | Standard Deviation | m/s | 8 weeks |
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| 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). | Posted | Mean | Standard Deviation | ratio (m/m) | 8 weeks |
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| 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). | Posted | Mean | Standard Deviation | ratio (seconds/seconds) | 8 weeks |
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| Secondary | Joint Kinematics | joint kinematics will be assessed using motion capture system | These data will never be analyzed as they were not collected. | Posted | 8 weeks |
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| Secondary | Joint Kinetics | joint kinematics will be assessed using motion capture and biomechanical force measurement systems | These data will never be analyzed as they were not collected. | Posted | 8 weeks |
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| Secondary | Activity (Step Count) | activity will be measured using accelerometer based step activity monitoring devices | These data will never be analyzed as they were not collected. | Posted | 8 weeks |
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| Secondary | Subject Opinions | subject opinions will be measured using surveys and questionnaires | These data will never be analyzed as they were not collected. | Posted | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Brace Resistance (Hardstop) | Default intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs | 0 | 5 | 0 | 5 | ||
| EG001 | ADR™ Brace Resistance | Condition using the novel elastomer to provide brace support ADR™ brace resistance | 0 | 5 | 1 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| discomfort while driving, back pain | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mukul Talaty | MossRehab | 2156636682 | mctalaty@einstein.edu |
| >=65 years |
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| Male |
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