NCT06927869

Brief Summary

The goal of this clinical trial is to investigate the effect of pully system exercise in in management of spasticity in cerebral palsy children Does pully system exercise has role in management of spasticity in cerebral palsy children ? Participants will: The participants assigned to the control group will receive a standard care program. This program is designed to provide basic supportive therapies without the specialized pulley system exercises

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

February 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 25, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

February 11, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

pully systemcerebral palsyspasticity

Outcome Measures

Primary Outcomes (2)

  • gross motor function of children with cerebral palsy using GMFMS

    evaluate change that occurs over time in the gross motor function of children with cerebral palsy

    3 months

  • pediatric balance scale

    A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population.

    3 months

Secondary Outcomes (1)

  • spasticity with EMG

    3 months

Other Outcomes (1)

  • erobic capacity

    3 months

Study Arms (2)

group 1

EXPERIMENTAL

the l group will receive a standard care program.

Other: designed physical therapy , pully system exercise

study

EXPERIMENTAL

study group will received pulley system exercises

Other: designed physical therapy , pully system exercise

Interventions

Participants assigned to the intervention group will engage in a specially designed physical therapy program focusing on pulley system exercises. The program is scheduled to occur three times per week, which is frequent enough to potentially induce meaningful improvements while allowing adequate rest between sessions to prevent fatigue and overtraining

group 1study

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The degree of spasticity is (1) according to Modified Ashwarth's scale
  • They able to understand orders given to them.
  • All children evaluated before and after the suggested period of the physical therapy program (3months).

You may not qualify if:

  • \- No fixed deformities.
  • They have neither visual nor auditory problems.
  • They have neither perceptual nor cognitive problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elsalam university

Tanta, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pediatric physical therapy

Study Record Dates

First Submitted

February 11, 2025

First Posted

April 15, 2025

Study Start

April 20, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-04

Locations