Cerebral Palsy, SpasticNCT04395729
Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy
An observational study of Cerebral Palsy, Spastic and Cerebral Palsy, Dyskinetic, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Cerebral Palsy, Dyskinetic, Infantile Hemiplegic Cerebral Palsy
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2020to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- Refusal to process medical data concerning the child for research purposes
Trial locations and contacts
1 site in 1 country.
France1 site
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69005
About this study
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).
- Keywords
- Upper limb, Contraction, Deformity, Multisite surgery, Treatment outcome
- Medical subject headings
- Cerebral Palsy, Congenital Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Available data up to 3 years before surgery and up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start9 Jul 2020
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Chaléat-Valayer, MD, PhD, Principal investigator, CMCR des Massues Croix rouge française
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395729
- Sponsor's protocol ID
- RETRO-CHIR
- Status last verified
- Aug 2024
- First submitted
- 15 May 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04395729
- Acronym / sponsor ID
- RETRO-CHIR
- Keywords
- Upper limb, Contraction, Deformity, Multisite surgery, Treatment outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Refusal to process medical data concerning the child for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Melbourne Assessment - Version 2
Time frame: Available data up to 3 years before surgery and up to 2 years after surgery
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).
1 secondary outcome
Assisting Hand Assessment - Version 5.0
Time frame: Available data up to 3 years before surgery and up to 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy, Spastic
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle Chaléat-Valayer, MD, PhD principal investigator
CMCR des Massues Croix rouge française
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic and Cerebral Palsy, Dyskinetic, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melbourne Assessment - Version 2 (time frame: Available data up to 3 years before surgery and up to 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.