Trial Outcomes & Findings for Cerebral Palsy: Short-burst Interval Training (NCT NCT03373890)
NCT ID: NCT03373890
Last Updated: 2019-07-10
Results Overview
Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable
COMPLETED
NA
12 participants
Change from baseline to immediately post SBLTT
2019-07-10
Participant Flow
Participants were recruited through a directed mailing to children with cerebral palsy receiving care at Seattle Children's Hospital between Sept 1, 2014 and June 30 2015.
In eligible if unable to walk at greater than their self selected walking speeds with orthotics on a treadmill.
Participant milestones
| Measure |
Short Burst Interval Treadmill Training High Frequency
All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive 5x/week for 4 weeks.
Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.
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Short Burst Interval Treadmill Training Low Frequency
All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive 2 x/week for10 weeks.
Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.
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|---|---|---|
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Overall Study
STARTED
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6
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6
|
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Overall Study
COMPLETED
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6
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6
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebral Palsy: Short-burst Interval Training
Baseline characteristics by cohort
| Measure |
Short Burst Interval Treadmill Training High Frequency
n=6 Participants
All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks
Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.
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Short Burst Interval Treadmill Training Low Frequency
n=6 Participants
All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks
Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.
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Total
n=12 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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6 Participants
n=5 Participants
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6 Participants
n=7 Participants
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12 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.6 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 2.0 • n=7 Participants
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8.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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5 Participants
n=5 Participants
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5 Participants
n=7 Participants
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10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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6 participants
n=5 Participants
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6 participants
n=7 Participants
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12 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Change from baseline to immediately post SBLTTPopulation: Change in average strides/day from baseline to immediately post SBLTT were compared between the high and low frequency groups/arms.
Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
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|---|---|---|
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Change in Walking Performance High Versus Low Frequency SBLTT Groups
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1872 strides per day
Standard Deviation 880
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1551 strides per day
Standard Deviation 952
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PRIMARY outcome
Timeframe: Change from baseline to immediately post SBLTTPopulation: Change in average strides/day \> 30 strides/min as measured by StepWatch accelerometry for one side a cross 5 days (4 weekdays and 1 weekend day)
Average Strides/day \> 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
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|---|---|---|
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Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups
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866 strides per day
Standard Error 652
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731 strides per day
Standard Error 522
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PRIMARY outcome
Timeframe: Change from baseline to immediately post SBLT.Population: Change in self selected walking speed between baseline and immediately post SBLTT was compared between the high and low frequency groups/arms.
Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
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|---|---|---|
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Change in Walking Capacity High Versus Low Frequency SBLTT Groups
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.21 meters per sec
Standard Deviation .3
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-.08 meters per sec
Standard Deviation .2
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PRIMARY outcome
Timeframe: Change from baseline to immediately post SBLTTPopulation: Change in distance walked in one minute between baseline and immediately post SBLTT compared between high and low frequency groups.
Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
|
|---|---|---|
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Change in Walking Endurance- High Versus Low Frequency SBLTT Groups
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13.8 meters
Standard Deviation 2.5
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8.8 meters
Standard Deviation 2.6
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SECONDARY outcome
Timeframe: Change from baseline to 6 weeks post SBLTTKnee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
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|---|---|---|
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Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups
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1.2 watts
Standard Deviation .11
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1.9 watts
Standard Deviation .19
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SECONDARY outcome
Timeframe: Change from baseline to immediately post SBLTTPopulation: Change in normalized isometric quadriceps strength as measured by Biodex, from baseline to immediately post SBLTT compared between high and low frequency groups/arms.
Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
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|---|---|---|
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Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups
|
.13 newton meters
Standard Deviation .25
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.14 newton meters
Standard Deviation .50
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SECONDARY outcome
Timeframe: Change from baseline to immediately post SBLTTPopulation: Change in rectus femoris cross sectional area as measured by 2D B Mode ultrasound, from baseline to immediately post SBLTT compared between high and low frequency groups/arms.
Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
|
|---|---|---|
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Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups
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.05 mm^2
Standard Deviation .02
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0 mm^2
Standard Deviation .03
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SECONDARY outcome
Timeframe: Change from baseline to immediately post SBLTTPopulation: Change in rectus femoris mid thigh fascicle length as measured by 2D B Mode ultrasound , from baseline to immediately post SBLTT compared between high and low frequency groups/arms.
Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Outcome measures
| Measure |
High Frequency 5x/Week
n=6 Participants
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 Participants
Received short burst interval training 2x week for total of 20 sessions
|
|---|---|---|
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Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups
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.06 millimeters
Standard Deviation .12
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.05 millimeters
Standard Deviation .13
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Adverse Events
High Frequency 5x/Week
Low Frequency 2x Week
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Frequency 5x/Week
n=6 participants at risk
This group received short burst interval treadmill training 5x/week for total of 20 sessions
|
Low Frequency 2x Week
n=6 participants at risk
Received short burst interval training 2x week for total of 20 sessions
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Mild severity
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16.7%
1/6 • Number of events 1 • Reported from consent/baseline to 6 week post intervention follow up which for high frequency group was approximately 4 months and for the low frequency group was 6 months
Severity coded Mild, moderate or severe Mild= inconvenience to day to day life Moderate= required medical attention Severe= Life threatening Relationship to study: Definitely Not Possibly Definitely Related
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0.00%
0/6 • Reported from consent/baseline to 6 week post intervention follow up which for high frequency group was approximately 4 months and for the low frequency group was 6 months
Severity coded Mild, moderate or severe Mild= inconvenience to day to day life Moderate= required medical attention Severe= Life threatening Relationship to study: Definitely Not Possibly Definitely Related
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Musculoskeletal and connective tissue disorders
Mild possibly related to study
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16.7%
1/6 • Number of events 1 • Reported from consent/baseline to 6 week post intervention follow up which for high frequency group was approximately 4 months and for the low frequency group was 6 months
Severity coded Mild, moderate or severe Mild= inconvenience to day to day life Moderate= required medical attention Severe= Life threatening Relationship to study: Definitely Not Possibly Definitely Related
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0.00%
0/6 • Reported from consent/baseline to 6 week post intervention follow up which for high frequency group was approximately 4 months and for the low frequency group was 6 months
Severity coded Mild, moderate or severe Mild= inconvenience to day to day life Moderate= required medical attention Severe= Life threatening Relationship to study: Definitely Not Possibly Definitely Related
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place