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Effect of Radial Shockwave on Calf Muscle Spasticity in Patients With Cerebral Palsy

NCT05883020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-05-10

No results posted yet for this study

Summary

the aim of this study to assess different outcome measures after applying standard physical therapy plus radial shockwave and compare the results with another group who received standard treatment only.

Design: double-blinded (assessor and data analyzer)

Methods: This study will be conducted in 4 rehabilitation facilities, Times for 1 month of intervention Assessment timeline: 3 times (T0: at baseline, T1: at 4 weeks, T2: follow up at 3 months. Outcome measures: the Modified Ashworth scale (MAS), Ankle ROM, Plantar surface area, Gross motor function, and quality of life

Conditions

  • Cerebral Palsy

Interventions

OTHER

Experimental Interventions

One session per week of rSWT will be applied using the BMI-1120 SHOCK MED device (BIO-MED-INC- ITALY). The following parameters will be used: Shocks number: 1500 per muscle, will be applied over the belly of the calf muscle using the 15 mm applicator head. The pressure will be 2 bar and the frequency will be 4 Hz. Patients will receive shock wave from prone position.

OTHER

Standard physical therapy program

Regular rehabilitation procedures consist of strengthing, stretching, facilitation and inhibitory techniques, splinting, developmental techniques, gait and balance training, and advice to parents. The duration of each session will be 1 hour, 3 times per week for 4 weeks

Sponsors & Collaborators

  • University of Hail

    lead OTHER

Principal Investigators

  • Hisham M Hussein, PHD · University of Hail

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2024-02-13
Completion
2024-03-01

Countries

  • Saudi Arabia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883020 on ClinicalTrials.gov