Trial · NCT05817409
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Goal Attainment Scaling (GAS) | 3 months, 1 year, 2 years | Attainment of personal treatment goals are scored on a standardised scale where -2 is the baseline score and 0 is the goal. Scores can be given for deterioration (-3), improvement but not attainment (-1) and more (+1) or much more (+2) than goal achieved). change in these outcomes between the different time points is assessed. |
| Secondary | range of motion | baseline, 3 months, 1 year, 2 years | range of motion of lower extremity joints |
| Secondary | spasticity | baseline, 3 months, 1 year, 2 years | Catch present or not |
| Secondary | Barry-Albright-Dystonia Scale (BADS) | baseline, 3 months, 1 year, 2 years | Dystonia is assessed in 8 body regions. A score of 0 to 4 can be given, where 0 represents no dystonia present, and 4 represents severe dystonia present. |
| Secondary | Scoliosis | baseline, 3 months, 1 year, 2 years | Cobb angle |
| Secondary | Selective motor control testing | baseline, 3 months, 1 year, 2 years | Selective control of movement of seperate joints is assessed for the hipflexors, knee-extensors and dorsiflexors of the foot. It is scored as normal, and if a patient can not move one joint seperatly from another joint, selectivity is scored as decreased (some selective control) or absent (no selective control at all) |
| Secondary | Functional strength testing | baseline, 3 months, 1 year, 2 years | Gross motor skills including squatting and toe walking are used to assess the functional strength of muscles. Normal strength testing is difficult in children with central nervous system motor disorders. Scores for the motor skills are: + child is able to execute motor skill, +/- child is able but with problems or incompletly, - child is not able to execute motor skill |
| Secondary | walking pattern/gait analysis | baseline, 3 months, 1 year, 2 years | walking pattern/gait analysis |
| Secondary | Pediatric Evaluation of Disability Inventory (PEDI) | baseline, 3 months, 1 year, 2 years | Questionnaire that assesses functional skilles, level of independence, and the extent of modifications required to perform functional activities in young children |
| Secondary | Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) | baseline, 3 months, 1 year, 2 years | The CPCHILD questionnaire is a validated measure of health-related quality of life for children with severe disabilities. |
| Secondary | Pain severity on Visual Analogue Scale (pain VAS) | baseline, 3 months, 1 year, 2 years | The severity of pain is score on a visual analogue scale (VAS) ranging from 0 to 10 where 0 represents no pain, and 10 the most excruciating pain possible |
| Secondary | ITB pump details | 3 months | Volume of ITB pump (20 ml or 40ml) |
| Secondary | Catheter tip heigth | 3 months, 1 year, 2 years | the height of the tip is assessed with insurgery X-ray. possibilities are: cervical, high thorecal (Th1-7), low thorecal (Th 8-12) |
| Secondary | Catheter type | 3 months | Different types of catheters are used. The specific cathter type (number provided by producer of pump) is used as an outcome measure |
| Secondary | Complications | 3 months, 1 year, 2 years | Complications related to ITB are noted. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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