NCT05972499

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.

Trial Health

35
At Risk

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 Aug 2023

Shorter than P25 for not_applicable

Status
unknown

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 16, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 2, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 16, 2023

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Group A (control group)

PLACEBO COMPARATOR

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

Group B (study group)

ACTIVE COMPARATOR

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

Interventions

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.

Group A (control group)Group B (study group)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Any visual or auditory impairments.
  • Epilepsy.
  • Any cognitive disorder.
  • Any fracture or orthopedic surgery in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
principal investigator

Study Record Dates

First Submitted

February 16, 2023

First Posted

August 2, 2023

Study Start

August 1, 2023

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

August 2, 2023

Record last verified: 2023-02