Trial Outcomes & Findings for Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke. (NCT NCT02693834)
NCT ID: NCT02693834
Last Updated: 2020-02-28
Results Overview
6 Minute Walk test (6MWT) to assess gait endurance using DA AFO and PLS AFO
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
at baseline
Results posted on
2020-02-28
Participant Flow
26 participants were screened for eligibility between March 2016 and October 2017 at two outpatient clinics (Pate Rehab, Dallas and Baylor Institute for Rehabilitation, Frisco) in Dallas, Texas. Out of the 26 screened participants, 3 did not meet inclusion criteria. 23 participants consented for the study.
Of the 23 consented participants 2 dropped out at baseline due to fatigue. 21 people completed the baseline measurements. 11 were randomized to DA AFO first week group, PLS AFO second week(1 lost to follow up) and 10 were randomized to PLS AFO first week, and DA AFO second week. 20 participants completed both arms.
Participant milestones
| Measure |
PLS AFO First Then DA AFO
At baseline Participants were assigned to wearing PLS AFO first for all measurements. Upon completion of baseline measurements,10 participants were randomly assigned to practice wearing the PLS AFO for the first week and the same participants were randomly assigned to the DA AFO for the second week
|
DA AFO First Then PLS AFO
At baseline Participants were assigned to wearing DA AFO first for all measurements. Upon completion of baseline measurements,11 participants were randomly assigned to practice wearing the DA AFO for the first week and the same 11 participants were randomly assigned to The PLS AFO for the second week. One person was lost to follow up in this group and so only 10 completed the protocol.
|
|---|---|---|
|
Baseline Measurement
STARTED
|
12
|
11
|
|
Baseline Measurement
COMPLETED
|
10
|
11
|
|
Baseline Measurement
NOT COMPLETED
|
2
|
0
|
|
Week 1 Practice
STARTED
|
10
|
11
|
|
Week 1 Practice
COMPLETED
|
10
|
11
|
|
Week 1 Practice
NOT COMPLETED
|
0
|
0
|
|
Week 2 Practice
STARTED
|
10
|
11
|
|
Week 2 Practice
COMPLETED
|
10
|
10
|
|
Week 2 Practice
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PLS AFO First Then DA AFO
At baseline Participants were assigned to wearing PLS AFO first for all measurements. Upon completion of baseline measurements,10 participants were randomly assigned to practice wearing the PLS AFO for the first week and the same participants were randomly assigned to the DA AFO for the second week
|
DA AFO First Then PLS AFO
At baseline Participants were assigned to wearing DA AFO first for all measurements. Upon completion of baseline measurements,11 participants were randomly assigned to practice wearing the DA AFO for the first week and the same 11 participants were randomly assigned to The PLS AFO for the second week. One person was lost to follow up in this group and so only 10 completed the protocol.
|
|---|---|---|
|
Baseline Measurement
Withdrawal by Subject
|
1
|
0
|
|
Baseline Measurement
Adverse Event
|
1
|
0
|
|
Week 2 Practice
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ankle Foot Orthosis
n=20 Participants
Participants will be assigned to practice with Posterior Leaf spring AFO for a week, then they will be assigned to practice with Double adjustable AFO for another week.
Posterior Leaf spring AFO: Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.
Double adjustable AFO: Double adjustable AFO is a custom AFO with double action metal upright joints
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
Mini Mental State exam
|
29.2 units on a scale
STANDARD_DEVIATION 1.0 • n=20 Participants
|
PRIMARY outcome
Timeframe: at baselinePopulation: 6MWT using DA AFO
6 Minute Walk test (6MWT) to assess gait endurance using DA AFO and PLS AFO
Outcome measures
| Measure |
Ankle Foot Orthosis
n=20 Participants
At Baseline, all participants wore both AFOs in random order and gait endurance, gait velocity and gait symmetry were assessed and compared.
|
|---|---|
|
Gait Endurance
with DA AFO
|
203.44 Meter
Standard Deviation 101.19
|
|
Gait Endurance
With PLS AFO
|
195.15 Meter
Standard Deviation 85.83
|
PRIMARY outcome
Timeframe: 1 week of practice with DA AFO and with PLS AFO randomly6MWT to assess gait endurance
Outcome measures
| Measure |
Ankle Foot Orthosis
n=20 Participants
At Baseline, all participants wore both AFOs in random order and gait endurance, gait velocity and gait symmetry were assessed and compared.
|
|---|---|
|
Gait Endurance
With DA AFO
|
255.07 Meter
Standard Deviation 99.62
|
|
Gait Endurance
With PLS AFO
|
235.53 Meter
Standard Deviation 88.08
|
SECONDARY outcome
Timeframe: at baseline,1 week with DA AFO, 1 week with PLS AFOUsing GAITRite for Self Selected Velocity (SSV) and Fast paced Velocity (FPV) walk Step symmetry was calculated as the ratio of affected step length over unaffected step length. Step symmetry was calculated for Self Selected Velocity (SSV) and Fast paced Velocity (FPV)
Outcome measures
| Measure |
Ankle Foot Orthosis
n=20 Participants
At Baseline, all participants wore both AFOs in random order and gait endurance, gait velocity and gait symmetry were assessed and compared.
|
|---|---|
|
Gait Symmetry
DA AFO SSV Baseline
|
1.16 ratio
Standard Deviation 0.27
|
|
Gait Symmetry
PLS AFO SSV baseline
|
1.18 ratio
Standard Deviation 0.36
|
|
Gait Symmetry
DA AFO SSV after 1 week
|
1.12 ratio
Standard Deviation 0.19
|
|
Gait Symmetry
PLS AFO SSV after 1 week
|
1.10 ratio
Standard Deviation 0.24
|
|
Gait Symmetry
DA AFO FPV Baseline
|
1.18 ratio
Standard Deviation 0.29
|
|
Gait Symmetry
PLS AFO FPV Baseline
|
1.22 ratio
Standard Deviation 0.37
|
|
Gait Symmetry
DA AFO FPV after 1 week
|
1.16 ratio
Standard Deviation 0.23
|
|
Gait Symmetry
PLS AFO FPV after 1 week
|
1.11 ratio
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: at baseline,1 week with DA AFO, 1 week with PLS AFOusing GAITRite for Self selected velocity (SSV)walk and fast paced velocity (FPV) walk
Outcome measures
| Measure |
Ankle Foot Orthosis
n=20 Participants
At Baseline, all participants wore both AFOs in random order and gait endurance, gait velocity and gait symmetry were assessed and compared.
|
|---|---|
|
Gait Velocity SSV and FPV
DA AFO SSV Baseline
|
0.58 meter per sec
Standard Deviation 0.26
|
|
Gait Velocity SSV and FPV
PLS AFO SSV baseline
|
0.58 meter per sec
Standard Deviation 0.26
|
|
Gait Velocity SSV and FPV
DA AFO SSV after 1 week
|
0.70 meter per sec
Standard Deviation 0.29
|
|
Gait Velocity SSV and FPV
PLS AFO SSV after 1 week
|
0.66 meter per sec
Standard Deviation 0.27
|
|
Gait Velocity SSV and FPV
DA AFO FPV Baseline
|
0.80 meter per sec
Standard Deviation 0.38
|
|
Gait Velocity SSV and FPV
PLS AFO FPV Baseline
|
0.78 meter per sec
Standard Deviation 0.36
|
|
Gait Velocity SSV and FPV
DA AFO FPV after 1 week
|
0.95 meter per sec
Standard Deviation 0.36
|
|
Gait Velocity SSV and FPV
PLS AFO FPV after 1 week
|
0.91 meter per sec
Standard Deviation 0.35
|
Adverse Events
PLS AFO
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
DA AFO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLS AFO
n=23 participants at risk
Posterior Leaf Spring AFO
|
DA AFO
n=23 participants at risk
Double Adjustable AFO
|
|---|---|---|
|
Nervous system disorders
Stroke
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected during the entire study enrollment time, for 3 weeks.
One participant could not complete baseline assessment due to fatigue associated with chemotherapy. IRB was contacted and a new exclusion criteria was added to exclude participants who were currently undergoing chemotherapy at the time of data collection. One participant had another stroke while at home before the final measurement during the second week of practice with the PLS AFO. This was not related to the study intervention, IRB was informed
|
0.00%
0/23 • Adverse event data were collected during the entire study enrollment time, for 3 weeks.
One participant could not complete baseline assessment due to fatigue associated with chemotherapy. IRB was contacted and a new exclusion criteria was added to exclude participants who were currently undergoing chemotherapy at the time of data collection. One participant had another stroke while at home before the final measurement during the second week of practice with the PLS AFO. This was not related to the study intervention, IRB was informed
|
Other adverse events
| Measure |
PLS AFO
n=23 participants at risk
Posterior Leaf Spring AFO
|
DA AFO
n=23 participants at risk
Double Adjustable AFO
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected during the entire study enrollment time, for 3 weeks.
One participant could not complete baseline assessment due to fatigue associated with chemotherapy. IRB was contacted and a new exclusion criteria was added to exclude participants who were currently undergoing chemotherapy at the time of data collection. One participant had another stroke while at home before the final measurement during the second week of practice with the PLS AFO. This was not related to the study intervention, IRB was informed
|
0.00%
0/23 • Adverse event data were collected during the entire study enrollment time, for 3 weeks.
One participant could not complete baseline assessment due to fatigue associated with chemotherapy. IRB was contacted and a new exclusion criteria was added to exclude participants who were currently undergoing chemotherapy at the time of data collection. One participant had another stroke while at home before the final measurement during the second week of practice with the PLS AFO. This was not related to the study intervention, IRB was informed
|
Additional Information
Priya Karakkattil, PT PhD
Baylor Institute for Rehabilitation
Phone: 469-888-5172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place