Downs SyndromeNCT06459440
Effect of Group-Task-Oriented Training on GMFM and ADL in Children With DS
A study testing Group Task oriented Training and Routine Treatment in people with Downs Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Downs Syndrome
- What is being tested?
- Group Task oriented Training and Routine Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54700
About this study
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.
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.
Read the 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
- Being tested
- Group Task oriented Training, Routine Treatment
- Keywords
- Down Syndrome, Group-Oriented task training, Motor skills
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Task oriented TrainingBehavioural
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 TreatmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jun 2024
- Primary completion30 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Downs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameen Fatima, MS*, Principal investigator, Riphah International Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459440
- Sponsor's protocol ID
- REC/RCR & AHS/23/0791
- Status last verified
- Sep 2024
- First submitted
- 11 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32029743
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06459440
- Acronym / sponsor ID
- REC/RCR & AHS/23/0791
- Conditions
- Downs Syndrome
- Keywords
- Down Syndrome, Group-Oriented task training, Motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Task Oriented Training | Experimental | Behavioral: Group Task oriented TrainingAll 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) |
| Routine Treatment | Active comparator | Other: Routine Treatment1.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). |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Task oriented TrainingGroup 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. | Behavioural | Group Task Oriented Training |
| Routine Treatment1.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) | Other | Routine Treatment |
Primary outcome
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).
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 32029743Antonarakis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameen Fatima, MS* principal investigator
Riphah International Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Task oriented Training and Routine Treatment in people with Downs Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GROSS MOTOR FUNCTION MEASURE (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06459440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.