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Completed

NCT Number: NCT05883020

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Salman Hospital

Ha'il, 3994, Saudi Arabia

About this study

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:

  • Modified Ashworth scale for muscle tone.
  • Goniometer for Ankle ROM.
  • EMed force platform for plantar surface area
  • Gross motor function scale for gross motor function
  • Cerebral Palsy Quality of Life Questionnaire for quality of life assessment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Radial shock wave 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

Other names: Standard physical therapy intervention

Primary outcomes

  1. calf muscle tone

    Time frame: at baseline

    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

  2. calf muscle tone

    Time frame: at 4 weeks

    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

  3. calf muscle tone

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

    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

  4. ankle joint ROM

    Time frame: at baseline

    traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment

  5. ankle joint ROM

    Time frame: at 4 weeks

    traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment

  6. ankle joint ROM

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

    traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment

  7. plantar surface area

    Time frame: at baseline

    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

  8. plantar surface area

    Time frame: at 4 weeks

    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

  9. plantar surface area

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

    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

  10. gross-motor function

    Time frame: at baseline

    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.

  11. gross-motor function

    Time frame: at 4 weeks

    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.

  12. gross-motor function

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

    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.

Secondary outcomes

  1. cerebral palsy quality of life questionnaire

    Time frame: at baseline

    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.

  2. cerebral palsy quality of life questionnaire

    Time frame: at 4 weeks

    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.

  3. cerebral palsy quality of life questionnaire

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

    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.

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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