Trial · NCT07891078
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Upper Limb Range of Motion and Dexterity - Modified Melbourne Assessment (MA2) | Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery. | Scores for the "Range of Motion" and "Dexterity" dimensions of the Modified Melbourne Assessment version 2 (MA2). The MA2 evaluates unilateral upper limb quality of function during tasks involving object approach, grasp, release, and manipulation in children aged 2.5 to 15 years with neurological impairment. Assessment is video-recorded during routine clinical care and scored retrospectively by an occupational therapist. Results are expressed as percentages for each of the four MA2 domains. Inter-rater reliability is excellent (R=0.95) and intra-rater reliability is very good (R=0.97). |
| Secondary | Unimanual Precision and Fluidity - Modified Melbourne Assessment (MA2) | Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery. | Scores for the "Precision" and "Fluidity" dimensions of the Modified Melbourne Assessment version 2 (MA2), expressed as percentages. These dimensions characterize movement quality in terms of joint positioning accuracy and movement smoothness during standardized upper limb tasks. |
| Secondary | Global Manual Dexterity - Box and Block Test (BBT) | Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery. | Raw score of the Box and Block Test (BBT): the number of wooden cubes (2.5 cm) that the child can transfer one at a time from one compartment to the other of a divided box in 1 minute. Assessed for each hand separately. A standardized and normed test for children from age 6, used to quantify gross manual dexterity as a complement to the Melbourne Assessment. |
| Secondary | Bimanual Performance - Assisting Hand Assessment (AHA) | Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery. | Total score of the Assisting Hand Assessment version 5.0 (AHA), expressed on an interval scale from 0 to 100 AHA units. The AHA evaluates the effectiveness of the assisting hand in bimanual performance in children aged 18 months to 18 years with unilateral impairment. Assessment is video-recorded during a structured play session (standardized toys, board game, or activity of daily living adapted to age), scored by a trained occupational therapist on 20 items rated 1 (ineffective) to 4 (effective). A difference of 5 AHA units is considered clinically significant. Inter-rater reliability is excellent (ICC=0.98). |
| Secondary | Patient and Parent Satisfaction with Surgical Outcomes - Goal Attainment | Postoperative assessment, between 12 and 36 months after surgery | Child/parent satisfaction regarding attainment of the individualized surgical goal, assessed on a 5-point Likert scale: not at all satisfied, slightly satisfied, moderately satisfied, satisfied, very satisfied. Collected during the scheduled follow-up consultation. |
| Secondary | Overall Patient and Parent Satisfaction with Surgical Treatment | minimum 12 months post-surgery, assessed through study completion | Overall satisfaction of children/parents regarding the surgical treatment, assessed via a structured satisfaction questionnaire administered by email at distance from surgery. The questionnaire includes a numerical satisfaction scale (0-10) for pain, activities of daily living, aesthetics, and motor function; a global satisfaction item compared to expectations; and questions about decision-making regarding the surgical pathway timing. |
| Secondary | Correlation Between Age at Surgery and Change in Manual Ability (MA2 Score) | Age collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery | Pearson or Spearman correlation between age at time of surgery (in years) and the change in MA2 score (score difference between pre-surgical baseline and end of observation period), assessed using the Manual Ability Assessment 2 (MA2) scale. |
| Secondary | Correlation Between Presence of Associated Cognitive Impairments and Change in Manual Ability (MA2 Score) | Cognitive impairment status collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery | Point-biserial correlation between presence vs. absence of associated cognitive impairments (binary variable, yes/no, assessed via clinical evaluation) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale. |
| Secondary | Correlation Between Presence of Associated Sensory Impairments and Change in Manual Ability (MA2 Score) | Sensory impairment status collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery | Point-biserial correlation between presence vs. absence of associated sensory impairments (binary variable, yes/no, assessed via clinical evaluation) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale. |
| Secondary | Correlation Between Pre-Surgical Zancolli Classification and Change in Manual Ability (MA2 Score) | Zancolli classification collected at baseline; MA2 score change pre and post surgery | Spearman correlation between pre-surgical Zancolli classification (ordinal scale assessing wrist and finger flexor function, categories I to III) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale. |
| Secondary | Correlation Between Pre-Surgical Corry Classification and Change in Manual Ability (MA2 Score) | Corry classification collected at baseline; MA2 score change pre and post surgery | Spearman correlation between pre-surgical Corry classification (ordinal scale assessing spasticity patterns of the upper limb, categories I to IV) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale. |
| Secondary | Correlation Between Pre-Surgical AHA Score and Change in Manual Ability (MA2 Score) | AHA score collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery | Pearson or Spearman correlation between the pre-surgical Assisting Hand Assessment (AHA) score (a standardized scale measuring how effectively children with unilateral upper limb impairment use their affected hand in bimanual activities, scored 0-100) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale. |
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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