Clinical trial NCT05883020: Effect of Radial Shockwave on Calf Muscle Spasticity in Patients With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: radial shockwave therapy
muscle tone
ROM
gross motor scale
quality of life
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Primary outcomes:
measure: calf muscle tone
timeFrame: at baseline
measure: calf muscle tone
timeFrame: at 4 weeks
measure: calf muscle tone
timeFrame: at follow up (3months after the end of the treatment)
measure: ankle joint ROM
timeFrame: at baseline
measure: ankle joint ROM
timeFrame: at 4 weeks
measure: ankle joint ROM
timeFrame: at follow up (3months after the end of the treatment)
measure: plantar surface area
timeFrame: at baseline
measure: plantar surface area
timeFrame: at 4 weeks
measure: plantar surface area
timeFrame: at follow up (3months after the end of the treatment)
measure: gross-motor function
timeFrame: at baseline
measure: gross-motor function
timeFrame: at 4 weeks
measure: gross-motor function
timeFrame: at follow up (3months after the end of the treatment)
Secondary outcomes:
measure: cerebral palsy quality of life questionnaire
timeFrame: at baseline
measure: cerebral palsy quality of life questionnaire
timeFrame: at 4 weeks
measure: cerebral palsy quality of life questionnaire
timeFrame: at follow up (3months after the end of the treatment)
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: King Salman Hospital
Study officials:
affiliation: University of Hail
name: Hisham M Hussein, PHD
role: PRINCIPAL_INVESTIGATOR
References: