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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05972499
Other study ID # 012004082
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date April 1, 2024

Study information

Verified date February 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the effectiveness of task - oriented training with pretend play on gross motor function, functional capacity and cognitive function in children with hemiplegic cerebral palsy.


Description:

PURPOSE: This study aims to investigate the effectiveness of task-oriented training with pretend play on: gross motor function, functional capacity and cognitive function in children with hemiplegic CP. BACKGROUND: Children with HCP experience difficulty with the motor function of the affected lower extremity. The majority of children with hemiplegia are able to walk without restrictions but more advanced gross motor skills are often affected. Task-Oriented Training is a contemporary neurological rehabilitation technique that has the prospects of improving the quality of life of children with CP. It is a function-based, goal directed intervention that requires active involvement of the patient in a therapy that is task and context-specific, which focused on the accomplishment of functional activities and participation. Pretend play is defined as play in which the child acts with intent that is representational. pretend play helps children learn how to express themselves, explore social interactions, and understand things and people within a real-world context. HYPOTHESES: There is effect of task-oriented training with pretend play on gross motor function, functional capacity and cognitive function in children with hemiplegic CP. . ………………… RESEARCH QUESTION: Does task-oriented training with pretend play has an effect on gross motor function, functional capacity and cognitive function in children with hemiplegic CP?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date April 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria: - Hemiplegic CP children of both genders. - Their age range will be from 6 up to 8 years. - They will be have spasticity will range from 1+ and 2, spasticity will be diagnosed based on the modified Ashworth scale. - They will be have gross motor function at levels II and III, gross motor function will be diagnosed based on Gross Motor Function Classification System Expanded and Revised. - They will be able to understand and follow direction. Exclusion Criteria: - Any visual or auditory impairments. - Epilepsy. - Any cognitive disorder. - Any fracture or orthopedic surgery in the last 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
task-oriented training with pretend play
Pretend play: Children engage in pretend play by acting out themes, taking on roles, assigning attributes to inanimate objects, and using objects as if they were something else Props will be added to hold the child interest. Role play costumes, or occupation props (police officer's suit), stimulate pretending elements. Task-oriented training: It is involving the active, repetitive practice of functional activities to learn or relearn a motor skill. Training implies that the behavioral experiences are not just repetition of the same sensorimotor skill but involves progressive challenges to a participant's capabilities and involves tasks that are meaningful to the participant. It is based on the following principles: functional goal-directed training focus on practicing specific activities of importance to the child during daily activities; planning activity-focused interventions by adapting knowledge of motor learning ; and allowing for the interest and participation of the children.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline in cognitive function on Wechsler intelligence scale for children (WISC-IV) at week13 WISC-IV is a valid instrument assessing cognitive function. It consists of 10 core subtests and 5 supplementary subtests. it provides four index scores, The Full-Scale Intelligent Quotient can be obtained from the sum of the 10 core sub test scores.
change= (Week 13 score - Baseline score).
Baseline and week 13
Primary change from baseline in functional capacity on six minutes walk test at week 13 six minutes walk test is a validated instrument assessing functional capacity. For the 6 - minute walking test during overground walking, the children will be encouraged to walk on 30 meters hard and even surface corridor for 6- minutes .
Change = (week 13 score -Baseline score).
Baseline and week 13
Primary change from baseline in gross motor function on Gross Motor Function Measure (GMFM) at week 13 Gross Motor Function Measure is a valid, and reliable standardized assessment tool that measures change in gross motor function. It consists of 88 items grouped into five functional dimensions. Score of each item has four points ranging from 0 to 3; where 0 indicates that the child does not initiate the task; 3 indicates that the child completes the task (100%).
change = (week 13 score -Baseline score).
Baseline and week 13
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