NCT06752226

Brief Summary

The study was conducted to examine the impact of the action observation training (AOT) on gross motor function in children with spastic 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 May 2023

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

Study Start

First participant enrolled

May 27, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 21, 2024

Last Update Submit

December 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    1\. Gross Motor Function Measure All children were assessed using the GMFM-88 scale. The GMFM scale has been validated to assess change in motor performance in children with CP. In this study we assessed the items of walking, running and jumping of the GMFM. The items are scored on four-point ordinal scales (0=cannot initiate; 1=initiates; 2=partially completes item; 3=completes item independently)

    8 weeks

Study Arms (2)

Effect of action observation training on gross motor function in children with cerebral palsy

EXPERIMENTAL

Action observation training used to improve gross motor function including walking, jumping and running domain in children with cerebral palsy by observing at imitate phases of gait cycle performed by a normal person

Other: action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance

action observation training

EXPERIMENTAL

Action observation training (AO) is cognitive intervention technique that is used to improve and learn exercise skills in sports, athletes, the general public and patient with motor impairment

Other: action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance

Interventions

In AOT, motor-related information can be available through the visual function by encoding into the mental representation of the memory to organize the intended action

Effect of action observation training on gross motor function in children with cerebral palsyaction observation training

Eligibility Criteria

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

You may qualify if:

  • Age ranges from 4 - 7 years. Level Ι - Π according to Gross Motor Functional Classification System (GMFCS) (Appendix II).
  • Grade 1, +1 and 2 of the Modified Ashworth Scale (Appendix III). Able to follow verbal commands and instructions.

You may not qualify if:

  • Significant visual or auditory impairments Structural or fixed soft tissue deformities of Lower extremities. Perception disorders. Botox injection in the lower extremity in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy , Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel study is a type of clinical study in which two or more groups of participations receive different interventions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 21, 2024

First Posted

December 30, 2024

Study Start

May 27, 2023

Primary Completion

November 16, 2023

Study Completion

February 4, 2024

Last Updated

December 30, 2024

Record last verified: 2024-12

Locations