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

University of Hail

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Standard physical therapy program; Other: Experimental Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT05883020

H-2023-150

Details and patient eligibility

About

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

Full 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

Enrollment: 70 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Standard physical therapy program

Sham Comparator group

Description:

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.

Treatment:

Other: Standard physical therapy program

Radial shockwave therapy (rSWT)

Active Comparator group

Description:

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.

Treatment:

Other: Experimental Interventions