NCT06925425

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). Task-specific electrical stimulation (TASES) is a therapeutic technique used primarily in rehabilitation settings to enhance motor function. The primary aim of TASES is to facilitate movement and improve motor learning by applying electrical stimulation to specific muscles during targeted tasks.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

April 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
18 days until next milestone

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
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

April 6, 2025

Last Update Submit

March 27, 2026

Conditions

Keywords

TASESCerebral palsyGross motor skillsUpper limbTask specific electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Improved upper limb gross motor skills

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

    after 3 months of treatment

Secondary Outcomes (1)

  • Improvement in joints range of motion

    after 3 months of treatment

Study Arms (2)

Group (A)

EXPERIMENTAL
Other: Designed Physical therapy program

Group (B)

EXPERIMENTAL
Other: Task specific electrical stimulation ( TASES )Other: Designed Physical therapy program

Interventions

Each child in group B receive the designed program plus the task specific electrical stimulation (TASES) for 20 minutes during the weight bearing exercises as push up , prone on hands on wedge and quadruped with weight shifting. The electrical stimulation is applied with the following parameters. Pulse frequency 25-50 HZ, pulse duration 300 micro second, intensity to display a visible muscle contraction, for 20 minutes. First channel, one electrode will be placed at the middle of triceps muscle, the second electrode will be placed more distal towards the elbow joint itself (about 3 cm above the olecranon process). Second channel, one electrode will be placed over finger and wrist extensors motor point to allow activation of fingers and wrist extensors. The other electrode will be placed over the tendonous portion of the forearm between motor points of extensor carpi radialis and extensor carpi ulnaris muscles.

Group (B)

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.

Group (A)Group (B)

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their age will be ranged from 2 to 6 years. Their grade of spasticity will be from 1+ to 2 according to Modified Ashworth scale (Baunsgaard etal., 2016). (APPENDIX II).
  • They will be on Level III and IV according to Gross Motor Functional Classification System (GMFCS) (Palisano et al., 2008).(APPENDIX III).
  • Parents/legals representatives consenting to their child's participation 5 - 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

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mohamed Bedair Ibrahim, professor of physical therapy

    kafr-elsheikh university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Bedair Ibrahim, Professor of Physical Therapy

CONTACT

Nesma Elsayed Barakat, Lecturer of Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Intervention study model Parallel assignment. The study will include thirty children with spastic quadriplegic CP of both sex. Their age will range from two to six years meeting the inclusion criteria will be randomly assigned to two experimental groups : First experimental group: children in this group will receive a designed physical therapy program, attending three sessions per week for three consecutive months. The duration of the session was one hour of the designed physical therapy program. Second experimental group: children in this group will receive the designed program plus the task specific electrical stimulation (TASES) for 20 minutes during the weight bearing exercises as push up , prone on hands on wedge and quadruped with weight shifting.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention study model Parallel assignment. The study will include thirty children with spastic quadriplegic CP of both sex. Their age will range from two to six years meeting the inclusion criteria will be randomly assigned to two experimental groups : First experimental group: children in this group will receive a designed physical therapy program, attending three sessions per week for three consecutive months. The duration of the session was one hour of the designed physical therapy program. Second experimental group: children in this group will receive the designed program plus the task specific electrical stimulation (TASES) for 20 minutes during the weight bearing exercises as push up , prone on hands on wedge and quadruped with weight shifting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
aalaa ahmed farrag

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 13, 2025

Study Start

May 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 29, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations