NCT07289386

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Cerebral palsyGait

Outcome Measures

Primary Outcomes (1)

  • Active range of motion

    measured by 2D gait analysis

    six weeks

Secondary Outcomes (1)

  • passive range of motion

    six weeks

Study Arms (2)

Study group

EXPERIMENTAL

which received IASTM therapy in addition to the selected physical therapy program

Procedure: IASTM therapy in addition to the selected physical therapy program

Control group

ACTIVE COMPARATOR

which received selected physical therapy program

Procedure: selected physical therapy program

Interventions

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

Study group

The selected physical therapy program was applied for one hour per session, three times per week (every other day), for six successive weeks

Control group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mai E. Abbass

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffessor of Pediatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations