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

NCT ID: NCT06459440

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2024-08-15

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.

Conditions

Downs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Task Oriented Training

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)

Group Type: EXPERIMENTAL

Group Task oriented Training

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Routine Treatment

Intervention Type: 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)

Interventions

Group Task oriented Training

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.

Intervention Type: BEHAVIORAL

Routine Treatment

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)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sameen Fatima, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International Univerisity

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

PMID: 32029743 (View on PubMed)

Other Identifiers

REC/RCR & AHS/23/0791

Identifier Type: -

Identifier Source: org_study_id