Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT03469999|
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Drug: Dysport Injectable Product||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Single Event Multi Level Chemoneurolysis With Dysport on Energy Expenditure and Walking Efficiency|
|Actual Study Start Date :||December 12, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Dysport Injectable Product
All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.
Drug: Dysport Injectable Product
All participants will receive Dysport injection at multi levels in the spastic lower limb(s)
Other Name: Botulinum toxin A
- Change in Energy expenditure [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]Energy expenditure [oxygen consumption (VO2)] will be measured during the 6 minute walk test using a portable metabolic cart.
- Change in Gait [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]Gait analysis will be measured by the GaitMat system while the child walks on the mat back and forth for five trials.
- Change in Muscle Spasticity [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]The Modified Ashworth Scale (MAS) measures muscle spasticity during passive stretching. Scores include 0, 1, 1+, 2, 3, and 4. A score of 0 indicates no increase in muscle tone/muscle spasticity and a score of 4 indicates a rigid muscle or maximum spasticity. A lower score after injection would indicate an improvement in muscle spasticity. The MAS will be performed in the hamstrings, gastrocnemius, and soleus muscles.
- Change in Muscle Spasticity [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]The Modified Tardieu Scale measures muscle spasticity during a passive stretch at both slow and fast speeds. First measure determines the maximum range of motion of a target muscle group in degrees. The second measure determines the angle where muscle resistance is felt during a rapid velocity stretch, recorded in degrees. The total score is calculated by subtracting measure one from measure two. A greater difference between measures indicates less muscle spasticity. The Modified Tardieu Scale will be performed in the hamstrings, gastrocnemius, and soleus muscles.
- Change in Quality of Life [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]The Pediatrics Quality of Life Inventory (PedsQL) consists of 23 questions ranging from 0-4 with a higher score indicating a higher quality of life. The total score will be calculated as well as the four subscales: physical (8 items), emotional (5 items), social (5 items), and school functioning (5 items). After injection, a higher total score as well as in each subscale indicated an increase in quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469999
|Contact: Nancy Lee, MSfirstname.lastname@example.org|
|Contact: Heakyung Kim, MDemail@example.com|
|Principal Investigator:||Heakyung Kim, MD||Columbia University Medical Center- Department of Rehabilitation|