CClinicalTrials.gg
CompletedNCT04395729Updated Aug 20, 2024

Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy

An observational study in Cerebral Palsy, Spastic, Cerebral Palsy, Dyskinetic and Infantile Hemiplegic Cerebral Palsy, sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. Completed at 1 site in France. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
23
Ages
8 Years to 18 Years
Sex
All
01

Study summary

The aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with Cerebral Palsy on unilateral functional capacities and bimanual performance. The investigators also assessed the attainment of individualized goals and tracked any potential factors that may have an impact on final results.

Read the detailed description

Cerebral Palsy is responsible for the most common neurological disorders in children. Although the primary lesion is non-evolutionary, the secondary consequences are evolutive, with neuro-orthopaedic degradation leading to soft tissue retraction and osteo-articular deformities. Hemiplegia occurs in approximately 30% of cases of Cerebral Palsy, and tone disorders (spasticity, dyskinesia) affecting the upper limb generally impact function, both in unilateral capacities (range of motion, dexterity, and fluidity of movement), and in bimanual performance. The focal treatment of spasticity by botulinum toxin injections, in combination with specific occupational therapy training, has proven to be effective in improving targeted functional goals. However, there is little evidence today of the effectiveness of treatment for the management of upper limb retraction and deformity, whether by stretching, orthosis/plaster or even surgery. And apart from its effectiveness on body structure, the functional effects of upper limb surgery in Cerebral Palsy have been little explored. The aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with Cerebral Palsy on unilateral functional capacities and bimanual performance, by using such tools as the Melbourne Assessment (Version 2) and the Assisting Hand Assessment (Version 5.0).

02

Conditions studied

  • Cerebral Palsy, Spastic
  • Cerebral Palsy, Dyskinetic
  • Infantile Hemiplegic Cerebral Palsy

Keywords

  • Upper limb
  • Contraction
  • Deformity
  • Multisite surgery
  • Treatment outcome
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 23 is below the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children (\<18 years) with cerebral palsy, presenting with unilateral upper limb injury.

Surgical procedures consisted of one and/or the other of the following interventions (possibility of combining several procedures depending on the highly individualized surgical decision): Adductor Pollicis Brevis Disinsertion, Flexor Carpi Ulnaris Disinsertion, Lengthening of fingers flexors, Transfer (FCU) to the Extensor Carpi Radialis Brevis, Pronator teres Disinsertion, Lengthening of elbow flexors, Wrist arthrodesis.

Inclusion criteria

  • Age \<18 years at time of surgical project
  • Unilateral upper limb injury due to Cerebral Palsy
  • Having undergone neuro-orthopaedic surgery of the upper limb with prior evaluation and comparative evaluation after surgery (6 months)

Exclusion criteria

Exclusion Criteria:

  • Refusal to process medical data concerning the child for research purposes
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
23 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Melbourne Assessment - Version 2

    The Melbourne Assessment evaluates unilateral upper limb functional capacities for children between 2.5 and 15 years of age with neurological impairment. It takes into account movement patterns, by characterizing the articular positioning observed during movements, as well as the fluidity of movement. Through 14 items analyzed along 4 axes (range of motion, precision, dexterity and fluidity), this test explores unilateral capacities to reach, grasp, release and manipulate simple objects. The evaluation is filmed according to a standardized protocol analyzed on video. The scoring is based on the video and the result is expressed as 4 scores in % for the areas of: range of motion, precision, dexterity, fluidity of movement. The reliability of the tool proved to be very good for the total score, for intra-examiner reproducibility (R=0.97) and inter-examiner reproducibility as well (R=0.95).

    Time frame: Available data up to 3 years before surgery and up to 2 years after surgery

Secondary outcomes

  1. Assisting Hand Assessment - Version 5.0

    The Assisting Hand Assessment (AHA) evaluates the effectiveness of the use of the assistant hand in bimanual performance in children with unilateral impairment between 18 months and 18 years of age. The test is scored on the video recording of the bimanual performance observation session, through 20 items rated on a rating scale between 1=ineffective and 4=effective; the different AHA items characterize the general use of the upper limb, the use of the arm, the grasp-release domain, fine motor adjustment and coordination. The total raw score is reduced to an interval score between 0 and 100. The reliability of the AHA has been shown to be very good for the total score, both intra-examiner (CCI= 0.99) and inter-examiner (CCI= 0.98). A difference of 5 points on the interval scale 0-100 is considered a significant difference.

    Time frame: Available data up to 3 years before surgery and up to 2 years after surgery

07

Study locations

1 site
  • Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
    Lyon, 69005, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04395729
Lead sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Responsible party
Sponsor
First posted
May 20, 2020
Start date
Jul 9, 2020
Primary completion
Mar 1, 2024
Completion
Jun 1, 2024
Last update
Aug 20, 2024

Study contacts

Emmanuelle Chaléat-Valayer, MD, PhD
principal investigator · CMCR des Massues Croix rouge française

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion