NCT05883020

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

Effect of Radial Shock Wave Therapy on Calf Muscle Tone, ROM, Gross Motor Scale, Plantar Surface and Quality of Life in Patients With Cerebral Palsy: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Hail · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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

Detailed description

the current study is a randomized controlled trial in which the researchers intended to examine the effect of adding radial shockwave therapy to standard physical therapy on the status of calf muscle spasticity and consequent effects on gross motor function, ankle joint ROM, plantar surface area, and quality of life. the experimental intervention will consist of 4 sessions of radial shockwave applied to the bulkiest area of the calf muscle in children having spastic cerebral palsy. participants will receive 1 session of radial shockwave per week and will continue their regular physical therapy as usual (3 sessions per week). outcome assessment will be conducted 3 times: at baseline, after the end of the treatment program, and at 3 months follow-up. the tools that will be used to collect data will be: 1. Modified Ashworth scale for muscle tone. 2. Goniometer for Ankle ROM. 3. EMed force platform for plantar surface area 4. Gross motor function scale for gross motor function 5. Cerebral Palsy Quality of Life Questionnaire for quality of life assessment

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-13
• Primary completion: 2024-02-13
• Completion: 2024-03-01
• First posted: 2023-05-31
• Last updated: 2024-05-10

Locations

1 site across 1 country: Saudi Arabia