Down SyndromeNCT06407895
Effects of Lower Limb Fitness Program in Children With DS
A study testing Lower Limb Fitness Program and Routine Therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down Syndrome is a congenital disorder resulting from the trisomy of the human chromosome 21, which will determine, among other characteristics, intellectual disability and growth retardation. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Lower Limb Fitness Program and Routine Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 30 Jul 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-12 years
- Both Genders.
- Single leg stance Test: If unable to stand for 5 seconds or less client at greater risk of injury from fall.
- Ability to understand and follow basic instructions.
- Deficits in Balance
Who cannot join
- Children who are unable to engage in a structured fitness program due to behavioral or physical limitations.
- Children who have undergone lower limb surgery or experienced significant lower limb injuries in the past six months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Lower Limb Fitness Program in Children With Down Syndrome
Down Syndrome is a congenital disorder resulting from the trisomy of the human chromosome 21, which will determine, among other characteristics, intellectual disability and growth retardation. Reduced muscular strength, cardiovascular capacity, sleep problems, and impaired walking performance are also observed in Down syndrome participants. The estimated global prevalence is around 0.1% of live births. Children with Down's syndrome (DS) often have greater postural sway and delay in motor development. Muscle weakness and hypotonia, particularly of the lower extremities are theorized to impair their overall physical health and ability to perform daily activities. Posture, balance, and movement issues are common in children with Down syndrome. The purpose of this study is to examine the effects of Lower Limb Fitness Program on dynamic balance and mobility in children with Down Syndrome. This study explore that Lower Limb Fitness Program could improve the dynamic balance and mobility in children with DS.
Read the detailed description
Group A: Experimental group:
Group A will receive Range of motion for 5 minutes involving movements that stretch and strengthen the muscles and improve the stability. Proprioceptive training for 5 minutes which involve Single-leg balance Start with 20-30 seconds per leg and gradually increase to 1 minute 2-3 sets per leg. Weight bearing exercises on an uneven surface (such as Bosu ball or stability disc) and jumping rope 5-10 minutes/session. All proprioceptive training done firstly with eyes open and then with close eyes. Squat-to-stand training proprioceptive training lower extremity. This intervention aims to get the muscles ready before the actual intervention and improve proprioceptive ability. Exercises will be given three times a week for 6 weeks with session conducting 45 minutes per sessions which involve Squat-to-stand training will repeat 30 times 3 sets for 20 min. 2minute break after 1 set.. Balance training which involves standing activities with support, progressing to unsupported as tolerated for 10 minutes/session.
Group B: Control group:
In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed.
Data will be assessed by assessor at baseline by single leg stance test and at the end of 6th session of treatment (Pre and post).
- Conditions
- Down Syndrome
- Being tested
- Lower Limb Fitness Program, Routine Therapy
- Keywords
- Down Syndrome, Dynamic Balance, Lower Limb Fitness Program,
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Limb Fitness ProgramOther
the stability of the core area can help to improve dynamic balance, coordinate the upper and lower trunk muscles, and reduce muscles' damage and abnormalities. Physiotherapy had a role in programming training for Down Syndrome children, for example, using squat to stand training that seemed to improving lower extremity muscle power. Squat-to-stand training will stimulate the proprioceptive stimulation on the trunk and lower extremity
Routine TherapyOther
In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Fitness Program | Experimental | Group A will receive Range of motion for 5 minutes involving movements that stretch and strengthen the muscles and improve the stability. Proprioceptive training for 5 minutes which involve Single-leg balance Start with 20-30 seconds per leg and gradually increase to 1 minute 2-3 sets per leg. Weight bearing exercises on an uneven surface (such as Bosu ball or stability disc) and jumping rope 5-10 minutes/session. All proprioceptive training done firstly with eyes open and then with close eyes. Squat-to-stand training proprioceptive training lower extremity. Receives: Other: Lower Limb Fitness Program |
| Routine Therapy | Active comparator | In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed. Receives: Other: Routine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test
The TUG test assesses the participant's mobility by timing how quickly they can complete the test and dynamic balance by assessing their ability to sit-to-stand, stand-to-sit, walk, and their ability to change directions. The participant stood up from a chair (46 cm seat height) with no armrests, walked 10 feet, turned around, walked back to the chair, and sat back down as quickly as possible
Measured: 6 weeks
Pediatric Balance scale
Pediatric version of balance scale is used to evaluate static and dynamic balance in children aged 3-15 years with mild-to-moderate motor impairment. The scale comprises 14 items including sitting balance, standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, retrieving object from floor, turning, and placing foot on stool items. Each item is scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Measured: 6 weeks
Modified Clinical Test of Sensory Interaction in Balance (CTSIB-M)
This test is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the older adult must rely on the somatosensory and vestibular systems to balance
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 posted9 May 2024
- Study start15 May 2024
- Primary completion15 Jul 2024
- Study completion30 Jul 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 Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- t will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-10 age will be formed in which participants will be randomly divided. Group A will only receive Lower Limb Fitness Program and group B will receive Routine Therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aqdas Javaid, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407895
- Sponsor's protocol ID
- REC/RCR&AHS/23/0786
- Status last verified
- Jul 2024
- First submitted
- 6 May 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Nov 4;101(44):e31565. doi: 10.1097/MD.0000000000031565.
PubMed 36343029
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Limb Fitness Program in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06407895
- Acronym / sponsor ID
- REC/RCR&AHS/23/0786
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Dynamic Balance, Lower Limb Fitness Program,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 May 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 is a congenital disorder resulting from the trisomy of the human chromosome 21, which will determine, among other characteristics, intellectual disability and growth retardation. Reduced muscular strength, cardiovascular capacity, sleep problems, and impaired walking performance are also observed in Down syndrome participants. The estimated global prevalence is around 0.1% of live births. Children with Down's syndrome (DS) often have greater postural sway and delay in motor development. Muscle weakness and hypotonia, particularly of the lower extremities are theorized to impair their overall physical health and ability to perform daily activities. Posture, balance, and movement issues are common in children with Down syndrome. The purpose of this study is to examine the effects of Lower Limb Fitness Program on dynamic balance and mobility in children with Down Syndrome. This study explore that Lower Limb Fitness Program could improve the dynamic balance and mobility in children with DS.
Detailed description
Group A: Experimental group:
Group A will receive Range of motion for 5 minutes involving movements that stretch and strengthen the muscles and improve the stability. Proprioceptive training for 5 minutes which involve Single-leg balance Start with 20-30 seconds per leg and gradually increase to 1 minute 2-3 sets per leg. Weight bearing exercises on an uneven surface (such as Bosu ball or stability disc) and jumping rope 5-10 minutes/session. All proprioceptive training done firstly with eyes open and then with close eyes. Squat-to-stand training proprioceptive training lower extremity. This intervention aims to get the muscles ready before the actual intervention and improve proprioceptive ability. Exercises will be given three times a week for 6 weeks with session conducting 45 minutes per sessions which involve Squat-to-stand training will repeat 30 times 3 sets for 20 min. 2minute break after 1 set.. Balance training which involves standing activities with support, progressing to unsupported as tolerated for 10 minutes/session.
Group B: Control group:
In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed.
Data will be assessed by assessor at baseline by single leg stance test and at the end of 6th session of treatment (Pre and post).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- t will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-10 age will be formed in which participants will be randomly divided. Group A will only receive Lower Limb Fitness Program and group B will receive Routine Therapy
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Fitness Program | Experimental | Other: Lower Limb Fitness ProgramGroup A will receive Range of motion for 5 minutes involving movements that stretch and strengthen the muscles and improve the stability. Proprioceptive training for 5 minutes which involve Single-leg balance Start with 20-30 seconds per leg and gradually increase to 1 minute 2-3 sets per leg. Weight bearing exercises on an uneven surface (such as Bosu ball or stability disc) and jumping rope 5-10 minutes/session. All proprioceptive training done firstly with eyes open and then with close eyes. Squat-to-stand training proprioceptive training lower extremity. |
| Routine Therapy | Active comparator | Other: Routine TherapyIn control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-12 years
- Both Genders.
- Single leg stance Test: If unable to stand for 5 seconds or less client at greater risk of injury from fall.
- Ability to understand and follow basic instructions.
- Deficits in Balance
Key exclusion criteria (2 listed)
- Children who are unable to engage in a structured fitness program due to behavioral or physical limitations.
- Children who have undergone lower limb surgery or experienced significant lower limb injuries in the past six months
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 |
|---|---|---|
| Lower Limb Fitness Programthe stability of the core area can help to improve dynamic balance, coordinate the upper and lower trunk muscles, and reduce muscles' damage and abnormalities. Physiotherapy had a role in programming training for Down Syndrome children, for example, using squat to stand training that seemed to improving lower extremity muscle power. Squat-to-stand training will stimulate the proprioceptive stimulation on the trunk and lower extremity | Other | Lower Limb Fitness Program |
| Routine TherapyIn control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed. | Other | Routine Therapy |
Primary outcome
Timed up and go test
Time frame: 6 weeks
The TUG test assesses the participant's mobility by timing how quickly they can complete the test and dynamic balance by assessing their ability to sit-to-stand, stand-to-sit, walk, and their ability to change directions. The participant stood up from a chair (46 cm seat height) with no armrests, walked 10 feet, turned around, walked back to the chair, and sat back down as quickly as possible
Pediatric Balance scale
Time frame: 6 weeks
Pediatric version of balance scale is used to evaluate static and dynamic balance in children aged 3-15 years with mild-to-moderate motor impairment. The scale comprises 14 items including sitting balance, standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, retrieving object from floor, turning, and placing foot on stool items. Each item is scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Modified Clinical Test of Sensory Interaction in Balance (CTSIB-M)
Time frame: 6 weeks
This test is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the older adult must rely on the somatosensory and vestibular systems to balance
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 2 Aug 2024.
- Background: PubMed 36343029Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Nov 4;101(44):e31565. doi: 10.1097/MD.0000000000031565.
- Individual participant dataSharing planned: No
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
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.
Aqdas Javaid, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Limb Fitness Program and Routine Therapy in people with Down 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 5 inclusion and 2 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 2 Aug 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?
Timed up and go test (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 NCT06407895, 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 2 Aug 2024.