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

NCT06459440 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0791
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Downs Syndrome

Keywords

Down Syndrome, Group-Oriented task training, Motor skills

Outcome Measures

Primary Outcomes (3)

• GROSS MOTOR FUNCTION MEASURE

  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).

  6 weeks

• Jebsen Hand function test

  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

  6 weeks

• Pediatric Evaluation of Disability Inventory (PEDI)

  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.

  6 weeks

Study Arms (2)

Group Task Oriented Training

EXPERIMENTAL

All session will be give 4 days a week 1.Week 1-2: Warm-up (10 mins) Core strengthening (10 mins) Posture training (10 mins) Balance training (10 mins) Week 3-4: Gross motor skills (10 mins) Fine motor skills (10 mins) Gait training (10 mins) Proprioception training (10 mins) Week 5-6 Activities of daily living (10 mins)

Behavioral: Group Task oriented Training

Routine Treatment

ACTIVE COMPARATOR

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) (26).

Other: Routine Treatment

Interventions

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.

Group Task Oriented Training

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)

Routine Treatment

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (1)

• Antonarakis SE, Skotko BG, Rafii MS, Strydom A, Pape SE, Bianchi DW, Sherman SL, Reeves RH. Down syndrome. Nat Rev Dis Primers. 2020 Feb 6;6(1):9. doi: 10.1038/s41572-019-0143-7.

  PMID: 32029743 RESULT

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Sameen Fatima, MS*

  Riphah International Univerisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 4-8 age will be formed in which participants will be randomly divided.Group A will be receive Group-Task-Oriented Training. Group B will be receive routine therapy.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 15, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)