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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Experimental Interventions
Standard physical therapy program
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Palsy focused on measuring radial shockwave therapy, muscle tone, ROM, gross motor scale, quality of life

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • King Salman HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Standard physical therapy program

Radial shockwave therapy (rSWT)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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.
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.
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.

Secondary Outcome Measures

cerebral palsy quality of life questionnaire
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.
cerebral palsy quality of life questionnaire
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.
cerebral palsy quality of life questionnaire
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.

Full Information

First Posted
March 17, 2023
Last Updated
May 27, 2023
Sponsor
University of Hail
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1. Study Identification

Unique Protocol Identification Number
NCT05883020
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
March 13, 2024 (Anticipated)
Study Completion Date
March 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
radial shockwave therapy, muscle tone, ROM, gross motor scale, quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard physical therapy program
Arm Type
Sham Comparator
Arm 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.
Arm Title
Radial shockwave therapy (rSWT)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Experimental Interventions
Other Intervention Name(s)
Radial shock wave therapy (rSWT)
Intervention Description
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
Intervention Name(s)
Standard physical therapy program
Other Intervention Name(s)
Standard physical therapy intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
calf muscle tone
Description
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
Time Frame
at baseline
Title
calf muscle tone
Description
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
Time Frame
at 4 weeks
Title
calf muscle tone
Description
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
Time Frame
at follow up (3months after the end of the treatment)
Title
ankle joint ROM
Description
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
Time Frame
at baseline
Title
ankle joint ROM
Description
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
Time Frame
at 4 weeks
Title
ankle joint ROM
Description
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
Time Frame
at follow up (3months after the end of the treatment)
Title
plantar surface area
Description
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
Time Frame
at baseline
Title
plantar surface area
Description
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
Time Frame
at 4 weeks
Title
plantar surface area
Description
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
Time Frame
at follow up (3months after the end of the treatment)
Title
gross-motor function
Description
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.
Time Frame
at baseline
Title
gross-motor function
Description
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.
Time Frame
at 4 weeks
Title
gross-motor function
Description
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.
Time Frame
at follow up (3months after the end of the treatment)
Secondary Outcome Measure Information:
Title
cerebral palsy quality of life questionnaire
Description
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.
Time Frame
at baseline
Title
cerebral palsy quality of life questionnaire
Description
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.
Time Frame
at 4 weeks
Title
cerebral palsy quality of life questionnaire
Description
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.
Time Frame
at follow up (3months after the end of the treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hisham M Hussein, PHD
Phone
+966 543704108
Email
hm.hussein@uoh.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham M Hussein, PHD
Organizational Affiliation
University of Hail
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Salman Hospital
City
Hail
ZIP/Postal Code
3994
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisham Hussein
Email
hm.hussein@uoh.edu.sa

12. IPD Sharing Statement

Learn more about this trial

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

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