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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05883020
• Other study ID #: H-2023-150
• Status: Completed
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: University of Hail
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2024
• Est. primary completion date: February 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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

Locations

Country	Name	City	State
Saudi Arabia	King Salman Hospital	Hail

Sponsors (1)

Lead Sponsor	Collaborator
University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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)