Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001535268
Ethics application status
Approved
Date submitted
5/09/2018
Date registered
13/09/2018
Date last updated
7/04/2021
Date data sharing statement initially provided
26/08/2019
Date results provided
26/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of selective percutaneous myofascial lengthening (SPML) and functional physiotherapy on gross motor function in children with cerebral palsy, aged 5-7 years
Scientific title
The effectiveness of a combined program of functional physiotherapy and minimally invasive paediatric orthopaedic surgical approach on gross motor function in children with cerebral palsy
Secondary ID [1] 295987 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 309498 0
spasticity 309499 0
secondary musculotendinous contractures 309500 0
Condition category
Condition code
Neurological 308335 308335 0 0
Other neurological disorders
Musculoskeletal 308384 308384 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: selective percutaneous myofascial lengthening (SPML) procedure in lower extremities and a 9-month post-surgical functional physiotherapy.
SPML procedure is performed in each patient by a paediatric orthopaedic surgeon, trained by the developer of SPML procedure (Roy Nuzzo, MD), with more than 17 years of experience with this procedure in cerebral palsy. The SPML is often combined with alcohol nerve blocks.
This technique of lengthening, done under general anesthesia as an outpatient, involves micro-incisions (2-3 mm) in the myofascia, via the skin, lengthening the muscle structure under it. It is performed in the hamstring, adductor and calf muscles.
The nerve block is a chemical neurolysis procedure with alcohol injection that is done at the same time as SPML in case of overactive obturator nerve, and consequently intense spasticity of the hip adductors, with the aim of alleviating the scissoring gait and helping the children to move their legs independently.
The post-surgical functional physiotherapy is provided by expert paediatric physiotherapists, with multiannual experience in this approach. It begins on the same afternoon of the surgery day based on surgeon's instruction. It includes knee immobilizers during rest time for one week and then only during night sleep; full weight-bearing exercises for the lower limbs. It is a specific strength-training programme via functional activities, for promoting independence and functioning, with the involvement of parents in all therapeutic procedure, for providing opportunities for their child to practice during the day. Patients receive physiotherapy sessions five times weekly for the first 6 weeks and then 2-3 times weekly until the end of 9 months of the study.
Decision about the allocation to intervention was taken by the parents according to the family-centred model of the decision making.
Intervention code [1] 312313 0
Treatment: Surgery
Intervention code [2] 312314 0
Rehabilitation
Comparator / control treatment
The control group receives no extra treatment and continues normally the standard physiotherapy care intervention throughout the study period. It is based on a eclectic approach, using a mixture of theoretical principles and practices derived from Bobath approach and functional approach.
Control group
Active

Outcomes
Primary outcome [1] 307316 0
D (Standing) dimension of the gross motor function measure (GMFM)
Timepoint [1] 307316 0
Baseline and 9 months after intervention commencement
Primary outcome [2] 307317 0
Gross Motor Function Classification System (GMFCS) level
Timepoint [2] 307317 0
Baseline and 9 months after intervention commencement
Primary outcome [3] 307318 0
Functional Mobility Scale (FMS)
Timepoint [3] 307318 0
Baseline and 9 months after intervention commencement
Secondary outcome [1] 351444 0
Walking velocity (m/sec) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait analysis data are collected, using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which is applied in every participant, consisted of 16 reflective markers that are placed on bony landmarks through a standardized process (Plug in Gait).
Timepoint [1] 351444 0
Baseline and 9 months after intervention commencement
Secondary outcome [2] 351445 0
passive range of motion of hip flexion bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [2] 351445 0
Baseline and 9 months after intervention commencement
Secondary outcome [3] 351446 0
isometric strength of hip flexors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [3] 351446 0
Baseline and 9 months after intervention commencement
Secondary outcome [4] 351447 0
Health-related quality of life using proxy version of DISABKIDS questionnaire expressed in 100-point scale (note: for the experimental group only)
Timepoint [4] 351447 0
Baseline and 9 months after intervention commencement
Secondary outcome [5] 351608 0
E (Walking) dimension of the gross motor function measure (GMFM) (PRIMARY OUTCOME)
Timepoint [5] 351608 0
Baseline and 9 months after intervention commencement
Secondary outcome [6] 351609 0
Interviews of parents with semi-structured questionnaires (note: for the experimental group only). The questions are related to the experiences and opinions of parents regarding the intervention procedure and its effects. The interventions will be tape-recorded and then will be indexed in order to perform a thematic analysis.
Timepoint [6] 351609 0
9 months after intervention commencement.
Secondary outcome [7] 351728 0
passive range of motion of hip extension bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [7] 351728 0
Baseline and 9 months after intervention commencement
Secondary outcome [8] 351729 0
passive range of motion of hip abduction bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [8] 351729 0
Baseline and 9 months after intervention commencement
Secondary outcome [9] 351730 0
passive range of motion of hip adduction bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [9] 351730 0
Baseline and 9 months after intervention commencement
Secondary outcome [10] 351731 0
passive range of motion of hip internal rotation bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [10] 351731 0
Baseline and 9 months after intervention commencement
Secondary outcome [11] 351732 0
passive range of motion of hip external rotation bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [11] 351732 0
Baseline and 9 months after intervention commencement
Secondary outcome [12] 351733 0
isometric strength of hip extensors, bilaterally via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [12] 351733 0
Baseline and 9 months after intervention commencement
Secondary outcome [13] 351734 0
isometric strength of hip abductors, bilaterally via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [13] 351734 0
Baseline and 9 months after intervention commencement
Secondary outcome [14] 351735 0
isometric strength of hip adductors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [14] 351735 0
Baseline and 9 months after intervention commencement
Secondary outcome [15] 351736 0
isometric strength of knee extensors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [15] 351736 0
Baseline and 9 months after intervention commencement
Secondary outcome [16] 351737 0
isometric strength of knee flexors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [16] 351737 0
Baseline and 9 months after intervention commencement
Secondary outcome [17] 351738 0
isometric strength of ankle dorsiflexors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)
Timepoint [17] 351738 0
Baseline and 9 months after intervention commencement
Secondary outcome [18] 351740 0
passive range of motion of knee flexion bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [18] 351740 0
Baseline and 9 months after intervention commencement
Secondary outcome [19] 351741 0
passive range of motion of knee extension bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [19] 351741 0
Baseline and 9 months after intervention commencement
Secondary outcome [20] 351742 0
passive range of motion of ankle dorsiflexion bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [20] 351742 0
Baseline and 9 months after intervention commencement
Secondary outcome [21] 351743 0
passive range of motion of ankle plantar flexion bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [21] 351743 0
Baseline and 9 months after intervention commencement
Secondary outcome [22] 351744 0
passive range of motion of foot supination bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [22] 351744 0
Baseline and 9 months after intervention commencement
Secondary outcome [23] 351745 0
passive range of motion of foot pronation bilaterally, via universal goniometer (note: for the experimental group only)
Timepoint [23] 351745 0
Baseline and 9 months after intervention commencement
Secondary outcome [24] 351747 0
Cadence (steps/min) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [24] 351747 0
Baseline and 9 months after intervention commencement
Secondary outcome [25] 351748 0
Stride length (m) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [25] 351748 0
Baseline and 9 months after intervention commencement
Secondary outcome [26] 351749 0
Step length (m) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [26] 351749 0
Baseline and 9 months after intervention commencement
Secondary outcome [27] 351750 0
Stance time (%) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [27] 351750 0
Baseline and 9 months after intervention commencement
Secondary outcome [28] 351751 0
Swing time (%) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [28] 351751 0
Baseline and 9 months after intervention commencement
Secondary outcome [29] 351752 0
Single support phase of walking (sec) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [29] 351752 0
Baseline and 9 months after intervention commencement
Secondary outcome [30] 351753 0
Double support phase of walking (sec) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [30] 351753 0
Baseline and 9 months after intervention commencement
Secondary outcome [31] 351755 0
Step time (sec) in each leg, via three-dimensional gait analysis (note: for the experimental group only). Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on osseous landmarks through a standardized process (Plug in Gait).
Timepoint [31] 351755 0
Baseline and 9 months after intervention commencement
Secondary outcome [32] 351756 0
Global Gait Graph Deviation Index (Global GGDI), expressed in normal standard deviations units, from the gait analysis (note: for the experimental group only). It is derived from the mean value of the Gait Graph Deviation Indices (GGDIs) of all the graphs of the three planes of motion (sagittal, frontal and transverse) and the pelvis, hip, knee and ankle levels of both sides (Left and Right). GGDI is a measure that summarizes all the observed instant deviations in a gait analysis graph in a single number using as units of measurement the the normal standard deviations.
Quantitative three-dimensional gait data were collected using a 100 Hz, six infrared 3D cameras Vicon Nexus 1.7 system (Vicon, Oxford, UK). The biomechanical model, which was applied in every participant, consisted of 16 reflective markers that were placed on bony landmarks through a standardized process (Plug in Gait).
Timepoint [32] 351756 0
Baseline and 9 months after intervention commencement

Eligibility
Key inclusion criteria
Spastic cerebral palsy,
Gross Motor Function Classification System (GMFCS) levels II-IV,
Normal or good cognitive ability,
Hip extensor strength higher than grade 2 via manual muscle testing.
Minimum age
5 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis other than cerebral palsy, dystonic or mixed motor disorder
Age outside the range
Gross Motor Function Classification System (GMFCS) levels I and V,
Severe cognitive disorders
Botulinum toxin injections within six months before the intervention
Previous orthopaedic procedures
Need for concomitant osteotomy
Hip flexor contracture
Hip extensor strength below manual muscle testing grade 3

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Normality of data is examined by using Kolmogorov-Smirnov tests and Q-Q plots.
Sample size calculation was performed with the software G*Power. Based on the fact that ANCOVA (two groups, beaseline scores as covariate) is the statistical test for examining the main research question, and for a large effect size (f=0.4), a=0.05 and statistical power 80%, a sample size of 52 participants is totally required. Thus, 26 participants per group were recruited.
The difference in the effectiveness of the experimental and control interventions, as regards the D and E dimensions of the gross motor function measure (GMFM) is tested with the use of ANCOVA. The pre-post difference in the Gross Motor Function Classification System (GMFCS) and Functional Mobility Scale (FMS) in each group seperately is examined by using the Wilcoxon test, and the comparison of the pre-post differences in the GMFCS and FMS between the groups is examined by using Mann-Whitney U test.
For the secondary outcomes measures regarding the experimental group, dependent t-test will be conducted to compare pre- and post-intervention values for gait analysis parameters, muscle strength, range of motion and DISABKIDS quationnaire.
P-values less than 0.05 are considered significant.
All the data analysis is performed with Statistical Package for Social Sciences (SPSS) for Windows, version 21.0

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/05/2017
Date of last participant enrolment
Anticipated
31/05/2019
Actual
21/05/2019
Date of last data collection
Anticipated
23/03/2020
Actual
5/03/2020
Sample size
Target
52
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 20824 0
Greece
State/province [1] 20824 0
Athens/Attica

Funding & Sponsors
Funding source category [1] 300581 0
Self funded/Unfunded
Name [1] 300581 0
Vasileios Skoutelis
Country [1] 300581 0
Greece
Primary sponsor type
Individual
Name
Vasileios Skoutelis
Address
Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica
Country
Greece
Secondary sponsor category [1] 300074 0
None
Name [1] 300074 0
Address [1] 300074 0
Country [1] 300074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301369 0
Scientific Council of the ‘Attikon’ University General Hospital
Ethics committee address [1] 301369 0
Ethics committee country [1] 301369 0
Greece
Date submitted for ethics approval [1] 301369 0
14/03/2017
Approval date [1] 301369 0
27/07/2017
Ethics approval number [1] 301369 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86778 0
Mr Vasileios Skoutelis
Address 86778 0
Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica
Country 86778 0
Greece
Phone 86778 0
+306972806727
Fax 86778 0
Email 86778 0
[email protected]
Contact person for public queries
Name 86779 0
Vasileios Skoutelis
Address 86779 0
Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica
Country 86779 0
Greece
Phone 86779 0
+306972806727
Fax 86779 0
Email 86779 0
[email protected]
Contact person for scientific queries
Name 86780 0
Vasileios Skoutelis
Address 86780 0
Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica
Country 86780 0
Greece
Phone 86780 0
+306972806727
Fax 86780 0
Email 86780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data of the study will not be available to other investigators because the same data may be used in the future for further analysis and publications.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of minimally invasive surgery and functional physiotherapy on motor function of children with cerebral palsy: A non-randomised controlled trial.2021https://dx.doi.org/10.1016/j.jor.2021.09.004
N.B. These documents automatically identified may not have been verified by the study sponsor.