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

NCT05883020 | Completed DMC

• 1 other identifier: H-2023-150
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy

Keywords

radial shockwave therapy; muscle tone; ROM; gross motor scale; quality of life

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• cerebral palsy quality of life questionnaire

  at baseline

• cerebral palsy quality of life questionnaire

  at 4 weeks

• cerebral palsy quality of life questionnaire

  at follow up (3months after the end of the treatment)

Study Arms (2)

Standard physical therapy program

SHAM COMPARATOR

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

Radial shockwave therapy (rSWT)

ACTIVE COMPARATOR

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

Interventions

Experimental Interventions 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.

Also known as: Radial shock wave therapy (rSWT)

Radial shockwave therapy (rSWT)

Standard physical therapy program 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

Also known as: Standard physical therapy intervention

Standard physical therapy program

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

King Salman Hospital

Hail, 3994, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hisham M Hussein, PHD

  University of Hail

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: May 31, 2023
• Study Start: March 13, 2023
• Primary Completion: February 13, 2024
• Study Completion: March 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

SA (1)