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

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

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Standard physical therapy program; Other: Experimental Interventions

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hisham M Hussein, PHD; Phone Number: +966 543704108; Email: hm.hussein@uoh.edu.sa

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 3994
    • Recruiting
    • King Salman Hospital
    • Contact: Hisham Hussein; Email: hm.hussein@uoh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age between 8-14
• diagnosed with spastic CP
• ability to walk alone or with assistance
• grades 1 -4 on Gross Motor Function Classification System
• at least score 1 on the Modified Ashworth Scale (MAS)
• ability to attend the treatment program and the outcome assessment sessions.

Exclusion Criteria:

• patients who received a botulinum toxin injection in the calf muscle during the last six months
• structural contracture of the calf muscle
• surgery in the lower extremity during the previous year
• those experiencing pain in the lower limbs
• severe associated neurological diseases as epilepsy
• medications affecting peripheral muscle tone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Standard physical therapy program; all participants will receive strengthing, stretching, facilitation and inhibitory techniques, splinting, developmental techniques, gait, and balance training. The duration of each session will be 1 hour, 3 times per week for 4 weeks.	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; Other Names: Standard physical therapy intervention
Active Comparator: Radial shockwave therapy (rSWT); One session per week of rSWT will be applied using shockwave device. 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: 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 Names: Radial shock wave therapy (rSWT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calf muscle tone	the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity	at baseline
calf muscle tone	the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity	at 4 weeks
calf muscle tone	the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity	at follow up (3months after the end of the treatment)
ankle joint ROM	traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment	at baseline
ankle joint ROM	traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment	at 4 weeks
ankle joint ROM	traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment	at follow up (3months after the end of the treatment)
plantar surface area	E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity	at baseline
plantar surface area	E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity	at 4 weeks
plantar surface area	E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity	at follow up (3months after the end of the treatment)
gross-motor function	Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.	at baseline
gross-motor function	Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.	at 4 weeks
gross-motor function	Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.	at follow up (3months after the end of the treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebral palsy quality of life questionnaire	Parents will be asked to report their level of quality of life using the Cerebral Palsy Qualityof life questionnair. the higher the gained score the better the quality of life achieved.	at baseline
cerebral palsy quality of life questionnaire	Parents will be asked to report their level of quality of life using the Cerebral Palsy Qualityof life questionnair. the higher the gained score the better the quality of life achieved.	at 4 weeks
cerebral palsy quality of life questionnaire	Parents will be asked to report their level of quality of life using the Cerebral Palsy Qualityof life questionnair. the higher the gained score the better the quality of life achieved.	at follow up (3months after the end of the treatment)

Collaborators and Investigators

• Sponsor: University of Hail
• Investigators: Principal Investigator: Hisham M Hussein, PHD, University of Hail

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): March 13, 2024
• Study Completion (Estimated): March 13, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: May 27, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; ROM; muscle tone; radial shockwave therapy; gross motor scale
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: H-2023-150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No