NCT06407349

Brief Summary

My aim of the research is to compare the effect of traditional therapy with the AAC device and identify if the AAC device is more effective for CP children than traditional therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

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

First Submitted

Initial submission to the registry

April 29, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

April 29, 2024

Last Update Submit

October 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional Communication

    Baseline measurement of all the individuals who are enrolled in the study will be taken by using the following assessment tools. Functional communication checklist; provide the score with reference to five domains- method of communication, communication interaction, communication function, expressive language skills, and receptive language skills Communication effective index will also be used which consists of sixteen items. Information Carrying words will be used based on age. After baseline measurements communication board intervention will be given to the individuals with cerebral palsy belonging to the experimental group while traditional therapy will be given to the control group. After providing the mentioned treatment to both groups for twenty four sessions, the post-assessment will be taken.

    8th week

Study Arms (2)

Communication Board

EXPERIMENTAL

customized individualized AAC communication Board with a step command Intervention description: 3 sessions per week, of 30 minutes total of 24 sessions. Both genders will be included. Children's ages range from 8 to 12 years.

Other: Communication Board

Traditional Therapy

OTHER

Traditional therapy with one-step command Intervention description: 3 sessions per week, of 30 minutes total of 24 sessions. Both genders will be included. Children's ages range from 8 to 12 years.

Other: Traditional Therapy

Interventions

communication board based on a functional communication picture of basic needs of categories ( food, clothes, object, and actions)

Communication Board

Traditional Therapy

Traditional Therapy

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children of both genders with Cerebral Palsy age group 8 years-12 years
  • Children with Cerebral Palsy having mild to moderate cognitive impairment and communication impairment
  • Children with comorbid conditions (epilepsy, microcephalia)
  • Children with physical abilities of functional Pointing, One Step Command
  • Following, Vocalization, and Imitation.

You may not qualify if:

  • Children with comorbid conditions (visual impairment, hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Education Academy

Rawalpindi, Punjab Province, 46620, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Self-Help DevicesEquipment and Supplies

Study Officials

  • Maimoona Ismail

    Riphah International University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 9, 2024

Study Start

May 6, 2024

Primary Completion

June 6, 2024

Study Completion

June 10, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations