Cerebral PalsyNCT05883020
Effect of Radial Shockwave on Calf Muscle Spasticity in Patients With Cerebral Palsy
A study testing Experimental Interventions and Standard physical therapy program in people with Cerebral Palsy, run by University of Hail at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Experimental Interventions and Standard physical therapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Cerebral Palsy
- Being tested
- Experimental Interventions, Standard physical therapy program
- Keywords
- radial shockwave therapy, muscle tone, ROM, gross motor scale, quality of life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental InterventionsOther
Also called Radial shock wave therapy (rSWT)
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.
Standard physical therapy programOther
Also called Standard physical therapy intervention
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Experimental Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at follow up (3months after the end of the treatment)
Secondary outcomes (3)
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.
Measured: at baseline
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.
Measured: at 4 weeks
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.
Measured: at follow up (3months after the end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start13 Mar 2023
- Primary completion13 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohamed Hussein, University of Hail
- Investigators
- Hisham M Hussein, PHD, Principal investigator, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883020
- Sponsor's protocol ID
- H-2023-150
- Status last verified
- May 2024
- First submitted
- 17 Mar 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05883020
- Acronym / sponsor ID
- H-2023-150
- Conditions
- Cerebral Palsy
- Keywords
- radial shockwave therapy, muscle tone, ROM, gross motor scale, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physical therapy program | Sham comparator | Other: Standard physical therapy programall 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. |
| Radial shockwave therapy (rSWT) | Active comparator | Other: Experimental InterventionsOne 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental InterventionsAlso: Radial shock wave therapy (rSWT)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 | Radial shockwave therapy (rSWT) |
| Standard physical therapy programAlso: Standard physical therapy interventionRegular 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 | Standard physical therapy program |
Primary outcome
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
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
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
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
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
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
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
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
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
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.
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.
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.
3 secondary outcomes
cerebral palsy quality of life questionnaire
Time frame: at baseline
cerebral palsy quality of life questionnaire
Time frame: at 4 weeks
cerebral palsy quality of life questionnaire
Time frame: at follow up (3months after the end of the treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham M Hussein, PHD principal investigator
University of Hail
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Interventions and Standard physical therapy program in people with Cerebral Palsy, run by University of Hail at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calf muscle tone (time frame: at baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.