Clinical trial NCT06943508: Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
Official title: Effects of Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Nordic walking
Balance
Postural Sway
Down Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial performed through convenient sampling, in which 32 DS children with age of 8-13 years will be taken randomly after screening and meeting inclusion criteria. Divided into two groups. Control group will recieve conventional therapy for 30 min for 5 days per week. Experimental will recieve nordic walk for 30 min for 5 days per week.
Primary purpose: OTHER

Brief summary: Down syndrome (DS) is one of the more commonly occurring genetic disorders, where mental retardation is combined with nutritional diseases. It is caused by having a third copy of chromosome 21, and there exist 3 forms; Simple Trisomy 21, Translocation Trisomy and Mosaic Trisomy. It is coupled with mental retardation, congenital heart defects, gastrointestinal anomalies .Nordic walking exerts beneficial effects on resting heart rate, blood pressure, exercise capacity, maximal oxygen consumption, and quality of life in patients with various diseases and can thus be recommended to a wide range of people as primary and secondary prevention.

This study will aim to examine the effects of Nordic walk on balance and functional strength in children with Down syndrome. A Randomized Controlled Trial will be conducted through convenient sampling 32 subjects will randomly be allocated into two groups. Group A will include 16 children and will receive conventional exercise program.

Group B will include 16 children and will receive Nordic walking program. Each session will be 30 minutes, 5 sessions per week. The total duration of the study will be 6 weeks.

Pediatric berg balance scale and modified time up and go test, and functional strength test will be used as outcome measure Data will be analyzed on SPSS version 29.0, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Detailed description: Down syndrome (DS) is one of the more commonly occurring genetic disorders, where mental retardation is combined with nutritional diseases. It is caused by having a third copy of chromosome 21, and there exist 3 forms; Simple Trisomy 21, Translocation Trisomy and Mosaic Trisomy. It is coupled with mental retardation, congenital heart defects, gastrointestinal anomalies, weak neuromuscular tone, dysmorphic features of the head, neck and airways, audio vestibular and visual impairment, characteristic facial and physical features, hematopoietic disorders and a higher incidence of other medical disorders. 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. Nordic walking exerts beneficial effects on resting heart rate, blood pressure, exercise capacity, maximal oxygen consumption, and quality of life in patients with various diseases and can thus be recommended to a wide range of people as primary and secondary prevention. This study will aim to examine the effects of Nordic walk on balance and functional strength in children with Down syndrome. A Randomized Controlled Trial will be conducted through convenient sampling 32 subjects will randomly be allocated into two groups. Group A will include 16 children and will receive conventional exercise program.

Group B will include 16 children and will receive Nordic walking program. Each session will be 30 minutes, 5 sessions per week. The total duration of the study will be 6 weeks.

Pediatric berg balance scale and modified time up and go test, and functional strength test will be used as outcome measure Data will be analyzed on SPSS version 29.0, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Eligibility criteria: Inclusion Criteria:

* Children with age group of 8-13

  * Both male and female
  * Functional ability sufficient enough to understand commands, direction and exercise guidance
  * Have ability to walk 60 meters independently according to 6- minute walk test
  * Children who can stand and walk with balance problem as revealed from physical examination having 20 to 42 scores on PBS.

Exclusion Criteria:

Uncontrolled seizures

* Any kind of orthopedic condition
* Registered visually impaired
* Atlanto Axial instability
* Any chest infection

Primary outcomes:
measure: Pediatric berg balance scale
timeFrame: Baseline, 6th week
measure: Timed UP & GO (TUG) test
timeFrame: Baseline, 6th week
measure: Functional Strength Test
timeFrame: Baseline, 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Study Principal Investigator
name: Hafiza Namra Khalid, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazurek D, Wyka J. Down syndrome--genetic and nutritional aspects of accompanying disorders. Rocz Panstw Zakl Hig. 2015;66(3):189-94.