NCT06270550

Brief Summary

The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.

Trial Health

57
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 Mar 2025

Shorter than P25 for not_applicable

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

February 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

February 12, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

Dynamic Movement Intervention

Outcome Measures

Primary Outcomes (1)

  • Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System.

    Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group with different intervention. As balance will be assessed using Humac Balance System.

    Baseline

Study Arms (2)

Dynamic movement intervention based group.

EXPERIMENTAL
Other: Dynamic Movement Intervention

Selective physical therapy program based group.

EXPERIMENTAL
Other: Dynamic Movement Intervention

Interventions

Dynamic movement intervention is a physical therapy approach for infants suffering abnormal developmental motor evolution caused by a known or unknown non-degenerative syndrome affecting the central nervous system

Dynamic movement intervention based group.Selective physical therapy program based group.

Eligibility Criteria

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

You may qualify if:

  • Age ranged from 4-7 years.
  • They can walk alone short distance and climb stairs holding on rail (Grade I \& II according to GMFCS).
  • They can understand and execute instructions.
  • They will be medically stable.
  • Degree of spasticity will be ranged from 1 to 1+ degree according to the Modified Ashworth Scale.

You may not qualify if:

  • Visual impairment (visual loss- cataract- myopia- hyperopia).
  • Hearing impairment (deafness)
  • Cognitive problem.
  • Uncontrolled Convulsions.
  • Orthopedic surgery for the affected lower limbs within one year.
  • Botulinum toxin injection within the last 6 months or within the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Mahmoud Awara, B.Sc

CONTACT

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
Bachelor's degree in Physical Therapy

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 21, 2024

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations