Trial · NCT03469999
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
NCT03469999, Phase 3, Completed, Columbia University; results first posted 2022-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy. Trials, record NCT03469999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03469999
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
- NCT number
- NCT03469999
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Cerebral Palsy
- Interventions
- Dysport Injectable Product
- First posted
- 2018-03-19
- Last updated
- 2022-06-01
- Results first posted
- 2022-06-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oxygen Consumption (ml/kg/Min) | 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. The participants will use a 10 meter walkway to walk back and forth during the 6 minutes to coverage as much distance as possible. During this time they will be wearing a portable spirometric device that collects the oxygen consumption (VO2) per minute. |
| Secondary | Gait Velocity (cm/s) | 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. |
| Secondary | Muscle Spasticity Using MAS | 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 are on a 6-point scale and include 0, 1, 1+, 2, 3, and 4. Scores range from 0 (better outcome), which indicates no increase in muscle tone/muscle spasticity to a score of 4 (worse outcome), which indicates a rigid muscle or maximum spasticity. Each subscale is independently scored and not combined to create a composite score. When calculating the mean score, 1+ is equivalent to a value of 1.5. |
| Secondary | Muscle Spasticity Using MTS | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | The Modified Tardieu Scale (MTS) measures muscle spasticity during a passive stretch at both slow and fast speeds. Scores range from 0, which indicates no resistance throughout the course of the passive movement (better outcome), to 5, which indicates that the joint is immovable (worse outcome). The first measure determines the maximum range of motion of a target muscle group in degrees and 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. |
| Secondary | Score on the Cerebral Palsy Quality of Life (CP QOL) Questionnaire | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | The Cerebral Palsy Quality of Life (CP QOL) Questionnaire consists of 66 items ranging from 1 to 9 with a lower score indicating a higher quality of life. The total score will be calculated as well as an individual score for the seven subscale domains: Social well-being and acceptance, functioning, Participation and physical health, Emotional well-being, Access to services, pain and feeling about disability, and family health. Scoring involves 2 steps. First, items are transformed to a scale with a possible range of 0-100. The scores are recoded as follows 1 to 0, 2 to 12.5, 3 to 25, 4 to 37.5, 5 to 50, 6 to 6.2, 7 to 75, 8 to 87.5, 9 to 100. Then the algebraic mean of item values is computed from the composite score for each domain. Once rescored, the final score ranges from 0 to 100, with 0 indicating a worse outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Oxygen Consumption (ml/kg/Min) | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | All participants who received Dysport and had VO2 level measured at baseline, week 4 and week 12. | ml/kg/min | MEAN |
| SECONDARY | Gait Velocity (cm/s) | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | Only includes participants who received Dysport and had gait analyzed at baseline, week 4 and week 12. | cm/sec | MEAN |
| SECONDARY | Muscle Spasticity Using MAS | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | Only includes participants who received Dysport and completed the MAS at baseline, week 4 and week 12. | score on a scale | MEAN |
| SECONDARY | Muscle Spasticity Using MTS | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | Data was not collected for any of the participants. | ||
| SECONDARY | Score on the Cerebral Palsy Quality of Life (CP QOL) Questionnaire | Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection | Data was not collected for any of the participants. |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Oxygen Consumption (ml/kg/Min) | Dysport Injectable Product | Baseline (pre-injection) | 14.82 | 95% Confidence Interval 12.76 to 16.88 | ml/kg/min |
| Oxygen Consumption (ml/kg/Min) | Dysport Injectable Product | 4 Week | 16.75 | 95% Confidence Interval 13.53 to 19.96 | ml/kg/min |
| Oxygen Consumption (ml/kg/Min) | Dysport Injectable Product | 12 Week | 28.77 | 95% Confidence Interval 9.33 to 48.21 | ml/kg/min |
| Gait Velocity (cm/s) | Dysport Injectable Product | Baseline (pre-injection) | 84.86 | 95% Confidence Interval 67.90 to 101.81 | cm/sec |
| Gait Velocity (cm/s) | Dysport Injectable Product | 4 weeks | 92.84 | 95% Confidence Interval 80.04 to 105.06 | cm/sec |
| Gait Velocity (cm/s) | Dysport Injectable Product | 12 weeks | 87.11 | 95% Confidence Interval 66.76 to 197.47 | cm/sec |
| Muscle Spasticity Using MAS | Dysport Injectable Product | MAS R Hip Adduction Baseline | 1.71 | 95% Confidence Interval 1.26 to 2.17 | score on a scale |
| Muscle Spasticity Using MAS | Dysport Injectable Product | MAS R Hip Adduction 4 week | 1.29 | 95% Confidence Interval 0.83 to 1.74 | score on a scale |
| Muscle Spasticity Using MAS | Dysport Injectable Product | MAS R Hip Adduction 12 week | 1.17 | 95% Confidence Interval 0.38 to 1.96 | score on a scale |
| Muscle Spasticity Using MAS | Dysport Injectable Product | MAS L Hip Adduction Baseline | 1.71 | 95% Confidence Interval 1.26 to 2.17 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dysport Injectable Product | 12 | |
| Overall Study | COMPLETED | Dysport Injectable Product | 10 | |
| Overall Study | NOT COMPLETED | Dysport Injectable Product | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dysport Injectable Product | 0 | 12 |
| Total, other adverse events | Dysport Injectable Product | 0 | 12 |
| Total, serious adverse events | Dysport Injectable Product | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03469999
GET https://conductscience.org/api/trials/v1/NCT03469999/results?page=2