NCT07008521

Brief Summary

to investigate and compare between effectiveness of Universal Exercise Unit and Rebound Therapy on genu recurvatum, muscle strength, balance, functional mobility and quality of life in spastic cerebral palsy children

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 6, 2025

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

May 29, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

genu recurvatum, Cerebral Palsy, Universal Exercise Unit, Rebound Therapy

Outcome Measures

Primary Outcomes (1)

  • degree of genu recurvatum

    degree of genu recurvatum will be measured by Radiological X-Ray

    10 minutes

Secondary Outcomes (4)

  • muscle power

    2 minutes

  • balance

    20 minutes

  • functional mobility

    20 minutes

  • Quality of child life

    20 minutes administration for each child

Study Arms (3)

control group

ACTIVE COMPARATOR

Control group: Children in this group will receive a traditional physical therapy program.

Procedure: Traditional physical therapy program

study group A

EXPERIMENTAL

Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program.

Procedure: Universal exercise unit

Study group B

EXPERIMENTAL

Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy

Procedure: Rebound Therapy

Interventions

universal exercise unit (UEU) for study groip (A)

study group A

rebound therpay for study group (B)

Study group B

traditional physical therapy program for contrl group

control group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with spastic CP both hemiplegic and diplegic.
  • Their ages will be ranged from 5-7 years old.
  • They will have mild spasticity (grade 1 and 1+) according to Modified Ashworth scale .
  • They will be in level I and II according to gross motor function classification system (GMFCS) .
  • They will be able to understand orders given to them.

You may not qualify if:

  • Subjects will be excluded if they have the following:
  • Visual or hearing impairment.
  • Severe limb deformities as structural genurecurvatum.
  • Surgical interference in the lower limbs for the last 6 months.
  • Botulinum toxin injection of the spastic lower limb muscles during the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 02, Egypt

Location

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nanees Essam Mohamed, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be assigned randomly into three groups of equal number (control group, study group A and study group B ) the randomization will be performed by simple randomization. Assessors will be blinded to the groups of the subjects.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 6, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

June 6, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations