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

NCT ID: NCT05883020

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2024-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Standard physical therapy program

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Experimental Interventions

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Radial shock wave therapy (rSWT); Standard physical therapy intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohamed Hussein

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hisham M Hussein, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Hail

Locations

King Salman Hospital

Hail, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2023-150

Identifier Type: -

Identifier Source: org_study_id