Walking Aided by a Leg Brace in Stroke Subjects
Conditions
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.
Interventions
DEVICEADR™ brace resistance
DEVICEConventional brace resistance (using hard stops)
Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-selected Walking Velocity | 8 weeks | walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat) |
| Step Length Symmetry | 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). |
| Step Time Symmetry | 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
| Measure | Time frame | Description |
|---|---|---|
| Activity (Step Count) | 8 weeks | activity will be measured using accelerometer based step activity monitoring devices |
| Subject Opinions | 8 weeks | subject opinions will be measured using surveys and questionnaires |
| Joint Kinematics | 8 weeks | joint kinematics will be assessed using motion capture system |
| Joint Kinetics | 8 weeks | joint kinematics will be assessed using motion capture and biomechanical force measurement systems |
Countries
United States
Participant flow
Pre-assignment details
This is a cross over study - so all participants received both interventions (i.e. were in both study arms).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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 | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Experimental Then Conventional Brace Resistance | Conventional Then Experimental Brace Resistance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 3.5 | 54.0 years STANDARD_DEVIATION 17 | 54.8 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Self-selected Walking Velocity
walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Brace Resistance (Hardstop) | Self-selected Walking Velocity | 0.71 m/s | Standard Deviation 0.39 |
| ADR™ Brace Resistance | Self-selected Walking Velocity | 0.74 m/s | Standard Deviation 0.38 |
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).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Brace Resistance (Hardstop) | Step Length Symmetry | 0.98 ratio (m/m) | Standard Deviation 0.24 |
| ADR™ Brace Resistance | Step Length Symmetry | 0.96 ratio (m/m) | Standard Deviation 0.25 |
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).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Brace Resistance (Hardstop) | Step Time Symmetry | 1.03 ratio (seconds/seconds) | Standard Deviation 0.52 |
| ADR™ Brace Resistance | Step Time Symmetry | 0.99 ratio (seconds/seconds) | Standard Deviation 0.43 |
Secondary
Activity (Step Count)
activity will be measured using accelerometer based step activity monitoring devices
Time frame: 8 weeks
Population: These data will never be analyzed as they were not collected.
Secondary
Joint Kinematics
joint kinematics will be assessed using motion capture system
Time frame: 8 weeks
Population: These data will never be analyzed as they were not collected.
Secondary
Joint Kinetics
joint kinematics will be assessed using motion capture and biomechanical force measurement systems
Time frame: 8 weeks
Population: These data will never be analyzed as they were not collected.
Secondary
Subject Opinions
subject opinions will be measured using surveys and questionnaires
Time frame: 8 weeks
Population: These data will never be analyzed as they were not collected.