NCT07631390

Brief Summary

Cerebral palsy is a non-progressive lesion of the brain occurring before 2 years of age resulting in disorders of posture and movement.( Ostensjo S, 2004)( Keles MN, 2018) . Although non-progressive, motor impairments develop as the child grows leading to activity and participation restriction. For children with CP, body function and structure impairments include changes in muscle tone and strength that affect the ability to control movement, specifically in regard to postural responses, selective control, regulation of activity, ability to learn unique movements, and inappropriate sequencing.(Ross SA, 2007)( Ostensjo S, 2004) . Lack of proper loading and maladaptive muscle pulls over time causes the skeletal system to adapt to positions of malalignment, malformation, and overall bone weakness (Beckung E, 2007) (Elbasan B, 2018) . These changes lead to delays in the natural progression of gross motor skills. As the child falls behind in motor function, they also fall behind in cognitive stimulation and development.( Akaya KU, 2018) . Understanding the anatomical and physiological implications that CP has on the developing child is necessary for physical therapists to treat this population, especially when utilizing electrical stimulation. Spastic quadriplegia Is a type of cerebral palsy that affects all four limbs and typically involves significant motor impairment. It results from brain damage that occurs before, during, or shortly after birth, affecting the areas of the brain responsible for movement and coordination. Electrical stimulation is a mode of physical therapy that can be utilized in the treatment of various nerve and muscle injuries, in addition to patients with acute and chronic pain. It involves an electrical pulse applied to a muscle or nerve that activates excitable tissue utilizing internal or external electrodes to build muscle strength, reduce pain, as well as create or support limb movement (Kerr C, 2007) .

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 May 2025

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

May 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improved upper limb functional motor skills

    The Quality of Upper Extremity Skills Test (QUEST) is used by assessment of the weight bearing domain

    2 months after treatment

Study Arms (2)

Study group

EXPERIMENTAL

Task-specific electrical stimulation, was delivered using the NMES (Neuromuscular Electrical Stimulation) mode on the Chattanooga ContinuumTM Portable two channel electrical stimulator. • This device is commonly used for muscle re-education, strengthening and functional rehabilitation. Every kid received three sessions per week for two months; each session lasted one hour, half an hour was for the designed physiotherapy program (as in the control group), and last 20 minutes was for the TASES application during the weight bearing exercises including push up exercise, prone on hands exercise, quadruped with weight shifting, in addition to transition activities as side sitting to quadruped exercise.

Device: The Chattanooga Continuum™Other: Designed Physical therapy program

Control group

ACTIVE COMPARATOR

Every kid received three sessions per week for two months; each session lasted one hour of designed physiotherapy program which included upper limb weight bearing exercises

Other: Designed Physical therapy program

Interventions

The Chattanooga Continuum™ (fig.2) is a portable 2 channel stimulator used by therapists in clinics and patients at home to provide electrical stimulation treatments in pain management (TENS) and neuromuscular stimulation (NMES). By combining TENS with NMES, users can simultaneously help manage pain and enhance exercise,3 thereby shortcutting the traditional muscle recovery cycle. Factor in a choice of program options including customizable waveforms,and you have a highly versatile and user-friendly rehabilitation tool that can help deliver optimal therapeutic outcomes. The Continuum Kit includes a transportation pouch and hand switch.

Study group

The program used a combination of open-and closed-chain exercises. Exercises for facilitating transitions as supine to sit with hand weight bearing , side lying to side sit , side sitting to quadruped, weight bearing exercises as prone on hands on wedge , quadruped with weight shifting and push up exercise for one hour.

Control groupStudy group

Eligibility Criteria

Age4 Years - 7 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their age will be ranged from 4 to 7 years.
  • Their grade of spasticity will be from 1+ to 2 according to Modified Ashworth scale
  • They will be on Level III and IV according to Gross Motor Functional Classification System (GMFCS).
  • Parents/legals representatives consenting to their child's participation
  • Diagnosed with Spastic Quadriplegic cerebral palsy

You may not qualify if:

  • Previous neurological or orthopedic surgery in the upperextremities.
  • Fixed deformity in the joints of upper limb. 3- Severe hearing and visual defect.
  • Irregular attendance at assessments or therapy sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalaa Ahmed Farrag

Alexandria, Egypt, 21515, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyQuadriplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Thirty children with spastic quadriplegic cerebral palsy after referred by pediatrician were randomly allocated into two equal groups: a control group (Group A) and a study group (Group B). The control group received a standardized physical therapy program, while the study group received the same program plus TASES.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aalaa Ahmed Farag

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 8, 2026

Study Start

May 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 10, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations