Trial Outcomes & Findings for Development of Walk Assist Device to Improve Community Ambulation (NCT NCT01994395)
NCT ID: NCT01994395
Last Updated: 2020-03-27
Results Overview
Measure of self selected and fast walking speeds by measuring the time it takes an individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go." and repeated "Please walk this distance as fast as you can safely when I say go."
COMPLETED
NA
53 participants
Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)
2020-03-27
Participant Flow
Participant milestones
| Measure |
Stride Management Assist (SMA) System
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
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|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Stride Management Assist (SMA) System
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
Baseline characteristics by cohort
| Measure |
Stride Management Assist (SMA) System
n=26 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=27 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=53 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=26 Participants
|
16 Participants
n=27 Participants
|
36 Participants
n=53 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=26 Participants
|
11 Participants
n=27 Participants
|
17 Participants
n=53 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 10 • n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
62 years
STANDARD_DEVIATION 13 • n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
61 years
STANDARD_DEVIATION 11.5 • n=50 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
|
Sex: Female, Male
Female
|
8 Participants
n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
9 Participants
n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
17 Participants
n=50 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
|
Sex: Female, Male
Male
|
17 Participants
n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
16 Participants
n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
33 Participants
n=50 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
25 participants
n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
50 participants
n=50 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
|
10 Meter Walk Test
|
0.7 meters per second
STANDARD_DEVIATION 0.1 • n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
0.65 meters per second
STANDARD_DEVIATION 0.1 • n=25 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
0.68 meters per second
STANDARD_DEVIATION 0.1 • n=50 Participants • One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
|
PRIMARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
Measure of self selected and fast walking speeds by measuring the time it takes an individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go." and repeated "Please walk this distance as fast as you can safely when I say go."
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Change in 10 Meter Walk Test From Baseline in Gait Speed
Baseline Assessment
|
0.7051 meters per second
Standard Deviation 0.122677
|
0.6606 meters per second
Standard Deviation 0.12067815
|
|
Change in 10 Meter Walk Test From Baseline in Gait Speed
Mid Training Assessment
|
0.8544 meters per second
Standard Deviation 0.202805061
|
0.7547 meters per second
Standard Deviation 0.16119851
|
|
Change in 10 Meter Walk Test From Baseline in Gait Speed
Post Training Assessment
|
0.9566 meters per second
Standard Deviation 0.20176847
|
0.8376 meters per second
Standard Deviation 0.191048354
|
|
Change in 10 Meter Walk Test From Baseline in Gait Speed
3 Month Post Training Assessment
|
0.9439 meters per second
Standard Deviation 0.226535699
|
0.8085 meters per second
Standard Deviation 0.169381067
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
ABC is a 16-item self-report measure in which patients rate their balance confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence.
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Activities-Specific Balance Confidence Scale (ABC)
Pre Training Assessment
|
66.7625 units on a scale
Standard Deviation 18.00944
|
67.6472 units on a scale
Standard Deviation 17.7136527
|
|
Activities-Specific Balance Confidence Scale (ABC)
Mid Training Assessment
|
73.2067 units on a scale
Standard Deviation 15.44828
|
70.4443 units on a scale
Standard Deviation 17.4234304
|
|
Activities-Specific Balance Confidence Scale (ABC)
Post Training Assessment
|
79.1630 units on a scale
Standard Deviation 13.30643987
|
77.99 units on a scale
Standard Deviation 13.3571932
|
|
Activities-Specific Balance Confidence Scale (ABC)
3 Month Post Training Assessment
|
81.6292 units on a scale
Standard Deviation 11.41238
|
78.3749 units on a scale
Standard Deviation 13.50986798
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
The NPRS is an 11-point scale from 0-10 where patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours from 0 (no pain) to 10 (the most intense pain imaginable).
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Pre Training Assessment
|
0.733336 units on a scale
Standard Deviation 1.589901
|
0.680004 units on a scale
Standard Deviation 1.67631206
|
|
Numeric Pain Rating Scale (NPRS)
Mid Training Assessment
|
1.166668 units on a scale
Standard Deviation 1.83081
|
0.72458 units on a scale
Standard Deviation 1.61792765
|
|
Numeric Pain Rating Scale (NPRS)
Post Training Assessment
|
0.879996 units on a scale
Standard Deviation 1.83081
|
0.599995 units on a scale
Standard Deviation 1.45295656
|
|
Numeric Pain Rating Scale (NPRS)
3 Month Post Training Assessment
|
1.568606 units on a scale
Standard Deviation 2.136855
|
0.587721053 units on a scale
Standard Deviation 1.235250407
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
A 49 item assessment grouped into 12 domains of health-related quality of life in stroke survivors; including areas of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking, personality. Each individual domain consists of 3 to 10 items that are averaged to generate an overall score, each item is rated on a 5- point Likert scale, with a minimum value of 1 (meaning the worst outcome) and a maximum value of 5 (meaning the best outcome). Domains scores (non-weighted average of item scores) and a summary score (non-weighted average of all 12 domain scores) are computed. Summary scores range from 49-245, with higher scores indicating better functioning.
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Stroke Specific Quality of Life Scale (SS-QOL)
Pre Training Assessment
|
198.16 units on a scale
Standard Deviation 21.30665
|
193.84 units on a scale
Standard Deviation 25.4945746
|
|
Stroke Specific Quality of Life Scale (SS-QOL)
Mid Training Assessment
|
204.8 units on a scale
Standard Deviation 23.02897
|
205.36 units on a scale
Standard Deviation 23.5741384
|
|
Stroke Specific Quality of Life Scale (SS-QOL)
Post Training Assessment
|
205.6 units on a scale
Standard Deviation 24.54248018
|
211.72 units on a scale
Standard Deviation 23.3158029
|
|
Stroke Specific Quality of Life Scale (SS-QOL)
3 Month Post Training Assessment
|
200.3529 units on a scale
Standard Deviation 25.22633
|
211.5789474 units on a scale
Standard Deviation 27.31771055
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
14 item questionnaire assessing individuals' confidence in their ability to perform tasks without falling. Individuals rate their confidence from 0 (not confident at all) to 100 (completely confident).
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
The Modified Falls Efficacy Scale (mFES)
Pre Training Assessment
|
8.3803 units on a scale
Standard Deviation 1.448756
|
8.4426 units on a scale
Standard Deviation 1.20545002
|
|
The Modified Falls Efficacy Scale (mFES)
Mid Training Assessment
|
8.9228 units on a scale
Standard Deviation 1.061062
|
8.719996 units on a scale
Standard Deviation 0.98649669
|
|
The Modified Falls Efficacy Scale (mFES)
Post Training Assessment
|
9.0971 units on a scale
Standard Deviation 0.937882386
|
9.075176 units on a scale
Standard Deviation 0.9848385
|
|
The Modified Falls Efficacy Scale (mFES)
3 Month Post Training Assessment
|
9.2941 units on a scale
Standard Deviation 0.785258
|
9.078111111 units on a scale
Standard Deviation 1.094633589
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
PHQ-9 is a 9-item self-report questionnaire designed to diagnose both the presence of depressive symptoms as well as to characterize the severity of depression. A single question rates how difficult problems have made it to do work, take care of things at home or get along with other people using a 4 level scale (not difficult at all to extremely difficult). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression.
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Pre Training Assessment
|
3.72 units on a scale
Standard Deviation 3.553402
|
3.68 units on a scale
Standard Deviation 4.31779265
|
|
Patient Health Questionnaire-9 (PHQ-9)
Mid Training Assessment
|
2.88 units on a scale
Standard Deviation 2.437895
|
3.12 units on a scale
Standard Deviation 4.12633817
|
|
Patient Health Questionnaire-9 (PHQ-9)
Post Training Assessment
|
2.32 units on a scale
Standard Deviation 2.267891826
|
2.16 units on a scale
Standard Deviation 3.15805848
|
|
Patient Health Questionnaire-9 (PHQ-9)
3 Month Post Training Assessment
|
3.352941 units on a scale
Standard Deviation 2.935583
|
2.631578947 units on a scale
Standard Deviation 2.8908000088
|
SECONDARY outcome
Timeframe: Session 0 (initial visit);Session 20 (between 6-8 weeks)Population: One subject dropped before being assigned to a group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
To compare the effect of training on the connections between the brain and leg muscles (descending corticomotor drive) using a non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals13. Very short duration (\< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram (EMG) from that muscle. A figure-of-eight or double cone coil is typically used to deliver focal magnetic pulses to a number of scalp sites over the cortical area representing a muscle of interest.
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Participants Receiving Transcranial Magnetic Stimulation (TMS)
Session 0
|
15 Participants
|
15 Participants
|
|
Participants Receiving Transcranial Magnetic Stimulation (TMS)
Session 20
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed, but time will keep running." The change in the distance walked in the 6-minute walk can be used to evaluate the efficacy of an exercise-training program or to trace the natural history of change in exercise capacity over time. The 6MWT is measured in meters.
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Change in 6 Minute Walk Test From Baseline in Distance (6MWT)
Pre Training Assessment
|
874.6067 units on a scale
Standard Deviation 220.4362
|
794.33 units on a scale
Standard Deviation 151.703575
|
|
Change in 6 Minute Walk Test From Baseline in Distance (6MWT)
Mid Treatment Assessment
|
1140.5040 units on a scale
Standard Deviation 364.1122684
|
963.1633 units on a scale
Standard Deviation 227.048913
|
|
Change in 6 Minute Walk Test From Baseline in Distance (6MWT)
Post Training Assessment
|
1268.24 units on a scale
Standard Deviation 344.0931699
|
1065.5567 units on a scale
Standard Deviation 227.1440369
|
|
Change in 6 Minute Walk Test From Baseline in Distance (6MWT)
3 Month Post Training Assessment
|
1230.3088 units on a scale
Standard Deviation 375.9471237
|
1035.1053 units on a scale
Standard Deviation 185.5663909
|
SECONDARY outcome
Timeframe: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.
The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. The minimal detectable change score for individuals with acute stroke is 6.9 points16 and 4.66 points in chronic stroke17.
Outcome measures
| Measure |
Stride Management Assist (SMA) System
n=25 Participants
Participants will be randomized into either the SMA group or impairment based (IPT) group.
The Stride Management Assist (SMA) System: Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
|
Impairment Based Therapy
n=25 Participants
Impairment based therapy will include traditional functional mobility training physical therapy.
Impairment based therapy: Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
|
|---|---|---|
|
Berg Balance Scale (BBS)
Pre Training Assessment
|
44 units on a scale, each item scored 0-4
Standard Deviation 6
|
44 units on a scale, each item scored 0-4
Standard Deviation 4
|
|
Berg Balance Scale (BBS)
Mid Training Assessment
|
46 units on a scale, each item scored 0-4
Standard Deviation 6
|
46 units on a scale, each item scored 0-4
Standard Deviation 4
|
|
Berg Balance Scale (BBS)
Post Training Assessment
|
48 units on a scale, each item scored 0-4
Standard Deviation 4
|
48 units on a scale, each item scored 0-4
Standard Deviation 3
|
|
Berg Balance Scale (BBS)
3 Month Post Training Assessment
|
48 units on a scale, each item scored 0-4
Standard Deviation 4
|
48 units on a scale, each item scored 0-4
Standard Deviation 3
|
Adverse Events
Stride Management Assist (SMA) System
Impairment Based Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
Rehabilitation Institute of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place