Clinical trial NCT05607134: Effect of Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Spastic CP Children
Official title: Effect of Radial Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Upper Limb in Children With Spastic Hemiplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Hemiplegic Cerebral palsy
Radial Extracorporeal Shock Wave
Peripheral magnetic stimulation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypotheses:

There will be an effect of radial extracorporeal shock wave therapy and peripheral magnetic stimulation on the following parameters, in children with spastic hemiplegia:

* Wrist flexors spasticity.
* Wrist joint range of motion.
* Hand grip muscles strength.
* Sensorimotor function of wrist and hand.

Detailed description: Significance of the study:

Reducing muscle hypertonia or spasticity in order to regain independent mobility is an essential goal of a physiotherapeutical treatment in neuro-rehabilitation. The rapid normalization of the muscle tone is a criterion that can crucially influence the outcome of future rehabilitation or in training programs.

Purposes of the study:

To evaluate the effect of radial extracorporeal shock wave therapy and peripheral magnetic stimulation on the following parameters, in Children with Spastic Hemiplegia:

* Wrist flexors spasticity.
* Wrist joint range of motion.
* Hand grip muscles strength.
* Sensorimotor function of wrist and hand.

Methods:

Forty-five children with hemiplegic cerebral palsy, aged from 6 to 10 years, will be enrolled in this study. Wrist flexors spasticity, Wrist joint range of motion, Hand grip muscles strength, Sensorimotor function of wrist and hand will be assessed.

Data Analysis and statistical design:

Normally distributed numerical data will be statistically described in terms of mean standard deviation, while not-normal data will be represented as median and range or inter-quartile range (IQR). Qualitative (categorical) data will be described in frequencies (number of cases) and percentage. Numerical data will be tested for the normal assumption using Kolmogorov Smirnov test.

Comparison of numerical variables between the study groups will be done using One Way Analysis of variance (ANOVA) test when normally distributed and Kruskal Wallis analysis of variance (ANOVA) test when not normal.

For comparing categorical data, Chi-square test will be performed. Exact test will be used instead when the expected frequency is less than 5.

A probability value (p value) less than 0.05 is considered statistically significant. All statistical calculations will be done using computer programs Microsoft Excel 2019 (Microsoft Corporation, NY, USA) and IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.

Eligibility criteria: Inclusion Criteria:

* • Spastic hemiplegic children will be included in this study.

  * The children ages will be ranged from 6-10 years chronologically.
  * Children will have wrist flexors degree of spasticity ranged from +1 to 2 on Modified Ashworth Scale.
  * The children will have Level III to Level IV according to the Manual Ability Classiﬁcation System.
  * All children will be medically stable.
  * Children take their anti-spasticity medications.
  * All children will be able to follow instructions.

Exclusion Criteria:

* • History of recent nonunion fracture of the upper extremities.

  * Neurological or orthopedic surgery in the upper extremities in the last 12 months before the study.
  * Received Botulinum toxin A injections in the last six months.
  * Fixed contractures and deformities.
  * Patients with a self-contained medical implant such as: a metal plate along the spastic limbs, pacemaker, cochlear implant, and so on.
  * Children with cognitive dysfunction.
  * Poor skin integrity.

Primary outcomes:
measure: Change of the muscle tone of the wrist flexors
timeFrame: at the beginning and after eight weeks of the intervention
Secondary outcomes:
measure: Change of wrist extension range of motion (ROM)
timeFrame: at the beginning and after eight weeks of the intervention.
measure: Change of handgrip strength
timeFrame: at the beginning and after eight weeks of the intervention.
measure: Change of Functionality of wrist and hand
timeFrame: at the beginning and after eight weeks of the intervention.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Hany A. Saad, M. SC.
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
name: KHALED A. MAMDOUH, PHD
role: STUDY_CHAIR
affiliation: Prof. of Ph.Th. for Pediatrics, Faculty of Physical Therapy, Cairo University
name: Hoda A. EL-TALAWY, PHD
role: STUDY_DIRECTOR
affiliation: Ass. Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
name: Mohamed A. Elshafey, PHD
role: STUDY_DIRECTOR
References: