Clinical trial NCT06407895: Effects of Lower Limb Fitness Program in Children With DS
Official title: Effects of Lower Limb Fitness Program in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down Syndrome
Dynamic Balance
Lower Limb Fitness Program,
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Timed up and go test
timeFrame: 6 weeks
measure: Pediatric Balance scale
timeFrame: 6 weeks
measure: Modified Clinical Test of Sensory Interaction in Balance (CTSIB-M)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aqdas Javaid, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.