Cerebral Palsy Spastic Diplegia
Conditions
Brief summary
This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.
Detailed description
Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation. This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.
Interventions
BEHAVIORALShort 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.,
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Muscle function assessor masked to frequency group, Muscle architecture captured via ultrasound Community walking activity collected by accelerometry, thus non-human data collection
Intervention model description
Pre/post intervention design with participants randomized to two different frequency of intervention
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III
Exclusion criteria
* undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Performance High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT | 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 |
| Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT | Average Strides/day \> 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups |
| Change in Walking Capacity High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLT. | Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups |
| Change in Walking Endurance- High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT | Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups | Change from baseline to 6 weeks post SBLTT | Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups |
| Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT | Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups |
| Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT | Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups |
| Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT | Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
In eligible if unable to walk at greater than their self selected walking speeds with orthotics on a treadmill.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 6 |
| 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 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Short Burst Interval Treadmill Training High Frequency | Short Burst Interval Treadmill Training Low Frequency | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.6 years STANDARD_DEVIATION 2.3 | 9.4 years STANDARD_DEVIATION 2 | 8.6 years STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 2 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups
Average Strides/day \> 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups | 866 strides per day | Standard Error 652 |
| Low Frequency 2x Week | Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups | 731 strides per day | Standard Error 522 |
p-value: 0.39Wilcoxon (Mann-Whitney)
Primary
Change in Walking Capacity High Versus Low Frequency SBLTT Groups
Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Walking Capacity High Versus Low Frequency SBLTT Groups | .21 meters per sec | Standard Deviation 0.3 |
| Low Frequency 2x Week | Change in Walking Capacity High Versus Low Frequency SBLTT Groups | -.08 meters per sec | Standard Deviation 0.2 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Primary
Change in Walking Endurance- High Versus Low Frequency SBLTT Groups
Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Population: Change in distance walked in one minute between baseline and immediately post SBLTT compared between high and low frequency groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Walking Endurance- High Versus Low Frequency SBLTT Groups | 13.8 meters | Standard Deviation 2.5 |
| Low Frequency 2x Week | Change in Walking Endurance- High Versus Low Frequency SBLTT Groups | 8.8 meters | Standard Deviation 2.6 |
p-value: 0.39Wilcoxon (Mann-Whitney)
Primary
Change in Walking Performance High Versus Low Frequency SBLTT Groups
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
Time frame: Change from baseline to immediately post SBLTT
Population: Change in average strides/day from baseline to immediately post SBLTT were compared between the high and low frequency groups/arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Walking Performance High Versus Low Frequency SBLTT Groups | 1872 strides per day | Standard Deviation 880 |
| Low Frequency 2x Week | Change in Walking Performance High Versus Low Frequency SBLTT Groups | 1551 strides per day | Standard Deviation 952 |
p-value: 0.39Wilcoxon (Mann-Whitney)
Secondary
Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups
Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups | .05 mm^2 | Standard Deviation 0.02 |
| Low Frequency 2x Week | Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups | 0 mm^2 | Standard Deviation 0.03 |
p-value: 0.008Regression, Logistic
Secondary
Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups
Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups | .06 millimeters | Standard Deviation 0.12 |
| Low Frequency 2x Week | Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups | .05 millimeters | Standard Deviation 0.13 |
p-value: 0.34Regression, Linear
Secondary
Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups
Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to 6 weeks post SBLTT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups | 1.2 watts | Standard Deviation 0.11 |
| Low Frequency 2x Week | Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups | 1.9 watts | Standard Deviation 0.19 |
p-value: 0.06Wilcoxon (Mann-Whitney)
Secondary
Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups
Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Population: Change in normalized isometric quadriceps strength as measured by Biodex, from baseline to immediately post SBLTT compared between high and low frequency groups/arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency 5x/Week | Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups | .13 newton meters | Standard Deviation 0.25 |
| Low Frequency 2x Week | Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups | .14 newton meters | Standard Deviation 0.5 |
p-value: 0.99Wilcoxon (Mann-Whitney)