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

NCT ID: NCT06943508

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-05-26

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.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: 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 B

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

Group Type: EXPERIMENTAL

Nordic Walk

Intervention Type: OTHER

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

Interventions

Conventional Therapy

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)

Intervention Type: OTHER

Nordic Walk

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hafiza Namra Khalid, MS-PPT

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

IMRAN AMJAD, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif Javed Javed, MS-PT

Role: CONTACT

a.javed@riphah.edu.pk

923224209422

Facility Contacts

Imran Amjad, PhD

Role: primary

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif Javed, MS PT

Role: backup

a.javed@riphah.edu.pk

923224209422

References

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

Reference Type: BACKGROUND

PMID: 26400113 (View on PubMed)

Other Identifiers

REC/RCR/AHS/namra khalid

Identifier Type: -

Identifier Source: org_study_id