NCT06750081

Brief Summary

The purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

Study Start

First participant enrolled

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

December 15, 2024

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • active ankle dorsiflexion range of motion (AROM)

    Baseline and at the end - through study completion, an average of 1 year

  • 10-meter walking test

    Baseline and at the end - through study completion, an average of 1 year

Study Arms (2)

Experimental

EXPERIMENTAL

receive an experimental intervention

Other: Designed rehabilitation program

Control

ACTIVE COMPARATOR

another therapy used to treat the same condition

Other: Physical Therapy

Interventions

Exercises to improve locomotor abilities of children with CP

Control

Program of exercises to enhance abilities

Experimental

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spasticity grade 1 to 1+, according to the Modified Ashworth Scale.
  • Can stand and walk autonomously.
  • Able to follow verbal commands and instructions.

You may not qualify if:

  • Fixed musculoskeletal deformities
  • significant cognitive disorders
  • significant perceptual disorders
  • significant auditory disorders
  • significant visual disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

Related Publications (1)

  • Peterson MD, Lukasik L, Muth T, Esposito P, Haapala H, Gordon PM, IglayReger H, Hurvitz EA. Recumbent cross-training is a feasible and safe mode of physical activity for significantly motor-impaired adults with cerebral palsy. Arch Phys Med Rehabil. 2013 Feb;94(2):401-7. doi: 10.1016/j.apmr.2012.09.027. Epub 2012 Oct 10.

    PMID: 23063881BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

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
Associate Professor

Study Record Dates

First Submitted

December 15, 2024

First Posted

December 27, 2024

Study Start

August 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 15, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations