ANZCTR - Registration

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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 information initially 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cerebral palsy

spasticity

secondary musculotendinous contractures

Condition category

Condition code

Neurological

Other neurological disorders

Musculoskeletal

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]

Treatment: Surgery

Intervention code [2]

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]

D (Standing) dimension of the gross motor function measure (GMFM)

Timepoint [1]

Baseline and 9 months after intervention commencement

Primary outcome [2]

Gross Motor Function Classification System (GMFCS) level

Timepoint [2]

Baseline and 9 months after intervention commencement

Primary outcome [3]

Functional Mobility Scale (FMS)

Timepoint [3]

Baseline and 9 months after intervention commencement

Secondary outcome [1]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [2]

passive range of motion of hip flexion bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [2]

Baseline and 9 months after intervention commencement

Secondary outcome [3]

isometric strength of hip flexors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [3]

Baseline and 9 months after intervention commencement

Secondary outcome [4]

Health-related quality of life using proxy version of DISABKIDS questionnaire expressed in 100-point scale (note: for the experimental group only)

Timepoint [4]

Baseline and 9 months after intervention commencement

Secondary outcome [5]

E (Walking) dimension of the gross motor function measure (GMFM) (PRIMARY OUTCOME)

Timepoint [5]

Baseline and 9 months after intervention commencement

Secondary outcome [6]

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]

9 months after intervention commencement.

Secondary outcome [7]

passive range of motion of hip extension bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [7]

Baseline and 9 months after intervention commencement

Secondary outcome [8]

passive range of motion of hip abduction bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [8]

Baseline and 9 months after intervention commencement

Secondary outcome [9]

passive range of motion of hip adduction bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [9]

Baseline and 9 months after intervention commencement

Secondary outcome [10]

passive range of motion of hip internal rotation bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [10]

Baseline and 9 months after intervention commencement

Secondary outcome [11]

passive range of motion of hip external rotation bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [11]

Baseline and 9 months after intervention commencement

Secondary outcome [12]

isometric strength of hip extensors, bilaterally via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [12]

Baseline and 9 months after intervention commencement

Secondary outcome [13]

isometric strength of hip abductors, bilaterally via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [13]

Baseline and 9 months after intervention commencement

Secondary outcome [14]

isometric strength of hip adductors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [14]

Baseline and 9 months after intervention commencement

Secondary outcome [15]

isometric strength of knee extensors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [15]

Baseline and 9 months after intervention commencement

Secondary outcome [16]

isometric strength of knee flexors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [16]

Baseline and 9 months after intervention commencement

Secondary outcome [17]

isometric strength of ankle dorsiflexors bilaterally, via hand-held dynamometry, expressed in pound-force (note: for the experimental group only)

Timepoint [17]

Baseline and 9 months after intervention commencement

Secondary outcome [18]

passive range of motion of knee flexion bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [18]

Baseline and 9 months after intervention commencement

Secondary outcome [19]

passive range of motion of knee extension bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [19]

Baseline and 9 months after intervention commencement

Secondary outcome [20]

passive range of motion of ankle dorsiflexion bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [20]

Baseline and 9 months after intervention commencement

Secondary outcome [21]

passive range of motion of ankle plantar flexion bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [21]

Baseline and 9 months after intervention commencement

Secondary outcome [22]

passive range of motion of foot supination bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [22]

Baseline and 9 months after intervention commencement

Secondary outcome [23]

passive range of motion of foot pronation bilaterally, via universal goniometer (note: for the experimental group only)

Timepoint [23]

Baseline and 9 months after intervention commencement

Secondary outcome [24]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [25]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [26]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [27]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [28]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [29]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [30]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [31]

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]

Baseline and 9 months after intervention commencement

Secondary outcome [32]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Greece

State/province [1]

Athens/Attica

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Vasileios Skoutelis

Address [1]

Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Scientific Council of the ‘Attikon’ University General Hospital

Ethics committee address [1]

1 Rimini Street
12462 Chaidari, Attica

Ethics committee country [1]

Greece

Date submitted for ethics approval [1]

14/03/2017

Approval date [1]

27/07/2017

Ethics approval number [1]

Summary

Brief summary

The primary purpose of this study is to examine the effectiveness of selective percutaneous myofascial lengthening (SPML or PERCS) procedure and 9-month post-surgical functional physiotherapy on gross motor function in children with spastic cerebral palsy, school-aged 5-7 years. SPML procedure is a novel, minimally invasive multilevel surgery, usually combined with alcohol nerve blocks. Functional physiotherapy is a task-specific strength training approach through functional activities with the involvement of family in all rehabilitation procedure. The main study hypothesis is that SPML procedure and functional physiotherapy is more effective in improving gross motor function than the regular physiotherapy care intervention (a mixture of Bobath and functional approaches).

Trial website

Trial related presentations / publications

Public notes

The application for Ethical Approval was made on 14/03/2017. Due to ongoing delays of a bureaucratic nature in the convening of the Scientific Council, the Approval was finally recieved on 27/07/2017. In view of such delays, it was decided that initial measurements for the Research could begin, while still waiting for the Approval.

Contacts

Principal investigator

Name

Mr Vasileios Skoutelis

Address

Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica

Country

Greece

Phone

+306972806727

Fax

[email protected]

Contact person for public queries

Name

Mr Vasileios Skoutelis

Address

Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica

Country

Greece

Phone

+306972806727

Fax

[email protected]

Contact person for scientific queries

Name

Mr Vasileios Skoutelis

Address

Medical School, National and Kapodistrian University of Athens
75 Mikras Asias St.
11527 Athens, Attica

Country

Greece

Phone

+306972806727

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Study results article	Yes	Skoutelis V.C., Kanellopoulos A., Vrettos S., Gkri... [More Details]
Conference poster	No	Skoutelis V.C., Anastasios Kanellopoulos, Stamatis... [More Details]	375930-(Uploaded-23-08-2019-22-35-08)-Other results publication.pdf
Conference poster	No	Skoutelis V.C., Anastasios Kanellopoulos, Stamatis... [More Details]	375930-(Uploaded-23-08-2019-22-37-13)-Other results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of minimally invasive surgery and functional physiotherapy on motor function of children with cerebral palsy: A non-randomised controlled trial.	2021	https://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.

Trial Review

Documents added manually

Documents added automatically