NCT06721650

Brief Summary

To investigate the effect of Perturbation-Based Balance Training on trunk proprioception and balance in hemiparetic cerebral palsy

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 Dec 2024

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

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 3, 2024

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • BIODEX balance system

    to evaluate postural balance. The BBS is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress.

    three months

  • Pediatric Balance Scale

    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

    three months

  • baseline digital inclinometer.

    for measuring lateral movement in applications like: Earth movement in the landslide zone. Detecting shear planes in hydraulic structures. Measuring stability during construction

    four weeks

Study Arms (2)

study group

OTHER
Other: Perturbation-Based Balance TrainingOther: the selected physical therapy exercise program

control group

OTHER
Other: the selected physical therapy exercise program

Interventions

Perturbation-based balance training (PBT; or reactive balance training or perturbation training) is balance training that uses repeated, externally applied mechanical perturbations to trigger rapid reactions to regain postural stability in a safe and controlled environment

study group

trunk control therapeutic exercise, static and dynamic balance treaining exercises

control groupstudy group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Thirty-eight children hemiplegic cerebral palsy
  • Age will range as (8:10) years old
  • Spastic hemiplegic cerebral palsy
  • Normal body mass index ranged from 1SD to -2SDaccording to BMI-for age Z score charts include an age and sex- specific BMI for children (WHO, 2007).
  • Gross motor function classification system: level I\&II

You may not qualify if:

  • Difficulty to communicate or to understand program instructions
  • any other neurological deficits or orthopaedic abnormalities,
  • secondary musculoskeletal complication
  • vestibular problems
  • any mental impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

December 15, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations