Nordic Walk on Balance and Functional Strength in Children With Down Syndrome

NCT06943508 | Recruiting DMC

• 1 other identifier: REC/RCR/AHS/namra khalid
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Nordic walking; Balance; Postural Sway; Down Syndrome

Outcome Measures

Primary Outcomes (3)

• Pediatric berg balance scale

  Pediatric balance scale is a modified version of berg balance scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum NORDIC WALK ON BALANCE AND FUNCTIONAL STRENGHT IN CHILDERN WITH DOWN SYNDROME 11 score of 56 points It has good reliability and validity with (ICC=0.997) (r=0.797, p \<0.05)

  Baseline, 6th week

• Timed UP & GO (TUG) test

  The timed UP \& GO (TUG) test was developed by Podsiadlo and Richardson in 1991 that is used to assess dynamic balance during the performance of a task. This test measures in second the time required for an individual to stand up from a standard chair with armrest, walk 3m and turn around with reliability and validity of (ICC=0.98; p\<0.01)

  Baseline, 6th week

• Functional Strength Test

  To assess functional performance in children with functional exercises in which the large muscle group that are important for standing and walking are being tested. Three closed kinetic chain exercises were chosen. Subjects were instructed to perform as many repetitions as possible in 30 seconds. ICC value ranged from 0.91 to 0.96

  Baseline, 6th week

Study Arms (2)

Group A

ACTIVE COMPARATOR

Control: Conventional therapy program for 30 min , 5 days per week during 6 week period

Other: Conventional Therapy

Group B

EXPERIMENTAL

Experimental: Nordic Walk for 30 min, 5 days per week during 6 week period

Other: Nordic Walk

Interventions

Conventional Therapy OTHER

Conventional Therapy group: Group A will be control group which will recieve conventional physical therapy program like curl up, lateral step up and sit to stand for 6 weeks( 5 sessions per week)

Group A

Nordic Walk OTHER

Nordic Walk group: Group B will recieve Nordic walking for 6 weeks ( 5 sessions per week)

Group B

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled seizures
• Any kind of orthopedic condition
• Registered visually impaired
• Atlanto Axial instability
• Any chest infection

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54900, Pakistan

RECRUITING

Related Publications (1)

• Mazurek D, Wyka J. Down syndrome--genetic and nutritional aspects of accompanying disorders. Rocz Panstw Zakl Hig. 2015;66(3):189-94.

  PMID: 26400113 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Hafiza Namra Khalid, MS-PPT

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: May 26, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)