Clinical trial NCT06459440: Effect of Group-Task-Oriented Training on GMFM and ADL in Children With DS
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Downs Syndrome
Keywords: Down Syndrome, Group-Oriented task training, Motor skills
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: GROSS MOTOR FUNCTION MEASURE
timeFrame: 6 weeks
measure: Jebsen Hand function test
timeFrame: 6 weeks
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International Univerisity
name: Sameen Fatima, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.