the Effectiveness of Task-oriented Training With Pretend Play in CP Children

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05972499
Collaborator
(none)
40
2
8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: task-oriented training with pretend play
N/A

Detailed 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?

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Therapeutic Outcomes of Task-oriented Training With Pretend Play in Children With Cerebral Palsy.
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group A (control group)

The children in this group will receive physical therapy exercises to improve gross motor function and functional performance for 30 minutes per session ,3 times per week for three successive months as the following: Forward and sideways walking between parallel bars, as well as walking training with a stepper. Obstacles such as rolls and wedges are placed across the walking track during gait training in an open manner

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.

Active Comparator: Group B (study group)

Task-oriented training with pretend play treatment: Individual interviews will be conducted with subjects and their parents to find their favorite story and to set up a pretend play situation for each subject. The child will have his specific script, will be constructed from his favorite story. The physical therapist will use modeling, prompts, and encouragement to initiate pretend play. Actions and verbalization on the scripts will be constructed to describe the performance of activities based on task-oriented training which include: Forward, sideways and backward walking. Walking through obstacle course. Walking up and down stairs. Walking up and down ramps. Running. Jumping. Each task will be given for 4 minutes and one minute rest. The child will be encouraged to complete the task and will be verbally cued during training. Tasks will be progressed according to each child's performance. These progressions included increasing the number of repetitions, and speed.

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.

Outcome Measures

Primary Outcome Measures

  1. change from baseline in cognitive function on Wechsler intelligence scale for children (WISC-IV) at week13 [Baseline and week 13]

    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).

  2. change from baseline in functional capacity on six minutes walk test at week 13 [Baseline and 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).

  3. change from baseline in gross motor function on Gross Motor Function Measure (GMFM) at week 13 [Baseline and 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
naira mohammed mosaad abdelmonem, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05972499
Other Study ID Numbers:
  • 012004082
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023