Cerebral Palsy (CP)NCT07289386
Effect of IASTM in Children With Diplegia
A study testing IASTM therapy in addition to the selected physical therapy program and selected physical therapy program in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
Trial summary
The aim was to evaluate the effect of using IASTM on passive ROM of the lower limbs and joint angles during gait in children with spastic diplegic CP. Methods: Thirty children with diplegic CP were randomly divided into 2 groups: a control group (which received a selected physical therapy program) and the study group… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- IASTM therapy in addition to the selected physical therapy program and selected physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Dec 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged from 5 to 8 years old.
- spasticity ranged from 1 to 1+, according to Modified Ashworth Scale
- Children at level II according to Gross Motor Function Classification System
- They achieved independent walking with or without assistive device
- able to follow instructions and understand commands.
Who cannot join
- Fixed muscle contractures or fixed bone deformities in the lower limb.
- Botox injection for the last six months.
- Orthopedic surgeries for the last year.
- Children with infectious diseases.
- Skin infection, seizures, and any lower limb soft tissue injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Instrument-assisted Soft Tissue Mobilization on Gait in Children With Spastic Diplegia
The aim was to evaluate the effect of using IASTM on passive ROM of the lower limbs and joint angles during gait in children with spastic diplegic CP. Methods: Thirty children with diplegic CP were randomly divided into 2 groups: a control group (which received a selected physical therapy program) and the study group (which received IASTM therapy in addition to the selected physical therapy program). They were treated three times weekly for six weeks. Passive ROM and active ROM during gait were assessed using a digital goniometer and Kinovea analysis software, respectively, before and after the proposed treatment period.
Read the detailed description
Methods: Thirty children with diplegic CP were randomly divided into 2 groups: a control group (which received a selected physical therapy program) and the study group (which received IASTM therapy in addition to the selected physical therapy program). They were treated three times weekly for six weeks. Passive ROM and active ROM during gait were assessed using a digital goniometer and Kinovea analysis software, respectively, before and after the proposed treatment period.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- IASTM therapy in addition to the selected physical therapy program, selected physical therapy program
- Keywords
- Cerebral palsy, Gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTM therapy in addition to the selected physical therapy programProcedure or surgery
The designed IASTM therapy was applied for 8-10 minutes per session, three times per week (every other day), for six successive weeks in addition to the selected physical therapy program was applied for one hour per session, three times per week (every other day), for six successive weeks
selected physical therapy programProcedure or surgery
The selected physical therapy program was applied for one hour per session, three times per week (every other day), for six successive weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | which received IASTM therapy in addition to the selected physical therapy program Receives: Procedure: IASTM therapy in addition to the selected physical therapy program |
| Control group | Active comparator | which received selected physical therapy program Receives: Procedure: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active range of motion
measured by 2D gait analysis
Measured: six weeks
Secondary outcomes (1)
passive range of motion
measured by a digital goniometer
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Mar 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai E. Abbass, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289386
- Sponsor's protocol ID
- P.T.REC/012/005090
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument-assisted Soft Tissue Mobilization on Gait in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT07289386
- Acronym / sponsor ID
- P.T.REC/012/005090
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral palsy, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 17 Dec 2025 (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 was to evaluate the effect of using IASTM on passive ROM of the lower limbs and joint angles during gait in children with spastic diplegic CP. Methods: Thirty children with diplegic CP were randomly divided into 2 groups: a control group (which received a selected physical therapy program) and the study group (which received IASTM therapy in addition to the selected physical therapy program). They were treated three times weekly for six weeks. Passive ROM and active ROM during gait were assessed using a digital goniometer and Kinovea analysis software, respectively, before and after the proposed treatment period.
Detailed description
Methods: Thirty children with diplegic CP were randomly divided into 2 groups: a control group (which received a selected physical therapy program) and the study group (which received IASTM therapy in addition to the selected physical therapy program). They were treated three times weekly for six weeks. Passive ROM and active ROM during gait were assessed using a digital goniometer and Kinovea analysis software, respectively, before and after the proposed treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: IASTM therapy in addition to the selected physical therapy programwhich received IASTM therapy in addition to the selected physical therapy program |
| Control group | Active comparator | Procedure: selected physical therapy programwhich received selected physical therapy program |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged from 5 to 8 years old.
- spasticity ranged from 1 to 1+, according to Modified Ashworth Scale
- Children at level II according to Gross Motor Function Classification System
- They achieved independent walking with or without assistive device
- able to follow instructions and understand commands.
Key exclusion criteria (5 listed)
- Fixed muscle contractures or fixed bone deformities in the lower limb.
- Botox injection for the last six months.
- Orthopedic surgeries for the last year.
- Children with infectious diseases.
- Skin infection, seizures, and any lower limb soft tissue injury.
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 |
|---|---|---|
| IASTM therapy in addition to the selected physical therapy programThe designed IASTM therapy was applied for 8-10 minutes per session, three times per week (every other day), for six successive weeks in addition to the selected physical therapy program was applied for one hour per session, three times per week (every other day), for six successive weeks | Procedure or surgery | Study group |
| selected physical therapy programThe selected physical therapy program was applied for one hour per session, three times per week (every other day), for six successive weeks | Procedure or surgery | Control group |
Primary outcome
Active range of motion
Time frame: six weeks
measured by 2D gait analysis
1 secondary outcome
passive range of motion
Time frame: six weeks
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Mai E. Abbass study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM therapy in addition to the selected physical therapy program and selected physical therapy program in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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 17 Dec 2025. 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 Egypt. 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. 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?
Active range of motion (time frame: six weeks). 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 17 Dec 2025.