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NCT Number: NCT06459440

Effect of Group-Task-Oriented Training on GMFM and ADL in Children With DS

Down syndrome, a genetic condition resulting from an additional copy of chromosome 21, manifests with distinct facial features and intellectual challenges. Individuals with Down syndrome often face delays in motor skills, speech, and language development, alongside potential health issues. Down syndrome commonly encounter difficulties in both gross and fine motor functions due to factors like low muscle tone. Nonetheless, targeted interventions, including physical, significantly enhance motor skills. Daily living activities for individuals with Down syndrome cover personal care and household tasks, with structured routines and consistent support fostering independence. Group Task-Oriented Training, focusing on skill improvement and social interaction through collaborative activities, offers a meaningful approach to enhancing the overall quality of life for individuals with Down syndrome.

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Key information

Conditions

Downs Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

About this study

Group A receive Group-Task-Oriented Training. Group B receive routine therapy. Both the groups receive intervention for 40 minutes per session 4 times a week for six weeks.This study will be a randomized controlled trial and will be completed over a 10-month period in Lahore. Data will be collected from PSRD Hospital and Rising Sun Institute for Special Children. The estimated sample size is 44 participants, will be divided into two groups using non-probability convenient sampling. Inclusion criteria for Down syndrome children aged 4-8 include willingness to engage in Group-Task-Oriented Training sessions and stable health conditions. Exclusion criteria involve recent surgeries or severe medical conditions hindering participation. Data collection tools comprise the Jebsen hand function test, Gross Motor Function Measure, and Pediatric Evaluation of Disability Inventory.Participants are randomly assigned to an Experimental Group undergoing group task-oriented training and a Control Group receiving routine physical therapy. The training sessions for both groups are detailed, focusing on motor skills, fine motor function, gait training, and activities of daily living.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Down syndrome children age ranged between 4-8 years (20).
  • Both male and female genders are included (21).
  • Children and their families willing to engage in Group-Task-Oriented Training sessions (20).
  • Participants in stable health conditions suitable for engaging in the prescribed training program (20).

Exclusion criteria

  • Any recent surgical procedure (21).
  • Children with severe medical conditions or comorbidities that may interfere with participation in the Group-Task-Oriented Training (21).
  • Children with severe physical limitations that could hinder active participation in the training sessions (21)

Treatment and study plan

Group Task oriented Training

Behavioral

Group Task-Oriented Training for individuals with Down syndrome is an approach that focuses on improving specific skills and promoting social interaction through collaborative activities. This training method involves organizing individuals with Down syndrome into small groups to work on tasks that target various developmental areas, such as motor skills, communication, and socialization. The tasks are designed to be meaningful, engaging, and relevant to the participants' daily lives.

Routine Treatment

Other

1.Week 1-2 : Foundation building (4 sessions per week) Gentle stretching exercises (20 minutes). Basic strengthening exercises (20 minutes) (26). Weeks 3-4: Balance and coordination (4 sessions per week ) Balance exercises and core stability (20 minutes). Coordination drills (20 minutes) (26). Weeks 5-6: Functional activities (4 sessions per week )

Incorporate functional activities into therapy (e.g., walking, reaching) (20 minutes)

Primary outcomes

  1. GROSS MOTOR FUNCTION MEASURE

    Time frame: 6 weeks

    The Gross Motor Function Measure (GMFM) is a clinical tool used to assess gross motor function in individuals with cerebral palsy. It evaluates five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Each dimension has specific items reflecting developmental motor milestones. Scoring is based on observed abilities, ranging from 0 (no ability) to 3 (complete ability). The total score indicates the individual's overall gross motor function. The GMFM is valuable for tracking progress over time and guiding intervention strategies for those with cerebral palsy (23).

  2. Jebsen Hand function test

    Time frame: 6 weeks

    The Jebsen Hand Function Test (JHFT) is a clinical tool assessing hand function and fine motor skills in daily activities. Tasks include writing, card manipulation, and object handling. Widely used in rehabilitation, it measures speed and efficiency in completing tasks, aiding treatment planning for conditions affecting hand function. The JHFT demonstrates good reliability and validity, ensuring consistent and accurate assessment results, making it valuable for tracking progress and guiding interventions in individuals with upper extremity conditions

  3. Pediatric Evaluation of Disability Inventory (PEDI)

    Time frame: 6 weeks

    The PEDI comprises three domains: self-care, mobility, and social function. Each domain evaluates specific tasks including feeding, dressing, walking, and communicating with others. It takes into consideration the child's age, developmental stage, and specific diagnosis.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Group-Task-Oriented Training on Gross Motor and Fine Motor Functions and Activities of Daily Living Skills in Children With Downs Syndrome.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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