Effect of Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Spastic CP Children

Cairo University (CU)

Status: Enrolling

Conditions: Hemiplegic Cerebral Palsy

Treatments: Device: Peripheral magnetic stimulation; Other: selected physical and occupational therapy program; Device: Radial Extracorporeal Shock Wave

Study type: Interventional

Funder types: Other

Identifiers

NCT05607134

012/003862

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

Physical and occupational therapy group

Sham Comparator group

Description:

The group will receive a Physical and occupational therapy program

Treatment:

Other: selected physical and occupational therapy program

Shock Wave group

Active Comparator group

Description:

The group will receive a radial Extracorporeal Shock Wave sessions

Treatment:

Device: Radial Extracorporeal Shock Wave

Peripheral Magnetic Stimulation group

Active Comparator group

Description:

The group will receive a Peripheral Magnetic Stimulation sessions

Treatment:

Device: Peripheral magnetic stimulation