Effect of IASTM in Children With Diplegia

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Procedure: IASTM therapy in addition to the selected physical therapy program; Procedure: selected physical therapy program

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; which received IASTM therapy in addition to the selected physical therapy program	Procedure: IASTM therapy in addition to the selected physical therapy program; 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
Active Comparator: Control group; which received selected physical therapy program	Procedure: selected physical therapy program; The selected physical therapy program was applied for one hour per session, three times per week (every other day), for six successive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active range of motion	measured by 2D gait analysis	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
passive range of motion	measured by a digital goniometer	six weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mai E. Abbass, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Gait; Cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: P.T.REC/012/005090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No