Down SyndromeNCT06943508
Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
A study testing Conventional Therapy and Nordic Walk in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Conventional Therapy and Nordic Walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 26 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Uncontrolled seizures
- Any kind of orthopedic condition
- Registered visually impaired
- Atlanto Axial instability
- Any chest infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54900
Imran Amjad, PhD, 9233224390125, imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
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.
Read more
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.
Read the 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
- Being tested
- Conventional Therapy, Nordic Walk
- Keywords
- Nordic walking, Balance, Postural Sway, Down Syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TherapyOther
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)
Nordic WalkOther
Nordic Walk group: Group B will recieve Nordic walking for 6 weeks ( 5 sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Control: Conventional therapy program for 30 min , 5 days per week during 6 week period Receives: Other: Conventional Therapy |
| Group B | Experimental | Experimental: Nordic Walk for 30 min, 5 days per week during 6 week period Receives: Other: Nordic Walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: Baseline, 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025
- Primary completion15 Apr 2025 (estimated)
- Study completion26 May 2025 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Namra Khalid, MS-PPT, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943508
- Sponsor's protocol ID
- REC/RCR/AHS/namra khalid
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazurek D, Wyka J. Down syndrome--genetic and nutritional aspects of accompanying disorders. Rocz Panstw Zakl Hig. 2015;66(3):189-94.
PubMed 26400113
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06943508
- Acronym / sponsor ID
- REC/RCR/AHS/namra khalid
- Conditions
- Down Syndrome
- Keywords
- Nordic walking, Balance, Postural Sway, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 26 May 2025 (estimated)
- First posted
- 24 Apr 2025 (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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Conventional TherapyControl: Conventional therapy program for 30 min , 5 days per week during 6 week period |
| Group B | Experimental | Other: Nordic WalkExperimental: Nordic Walk for 30 min, 5 days per week during 6 week period |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with age group of 8-13
Key exclusion criteria (5 listed)
- Uncontrolled seizures
- Any kind of orthopedic condition
- Registered visually impaired
- Atlanto Axial instability
- Any chest infection
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 |
|---|---|---|
| Conventional TherapyConventional 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) | Other | Group A |
| Nordic WalkNordic Walk group: Group B will recieve Nordic walking for 6 weeks ( 5 sessions per week) | Other | Group B |
Primary outcome
Pediatric berg balance scale
Time frame: Baseline, 6th week
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)
Timed UP & GO (TUG) test
Time frame: Baseline, 6th week
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)
Functional Strength Test
Time frame: Baseline, 6th week
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 26400113Mazurek D, Wyka J. Down syndrome--genetic and nutritional aspects of accompanying disorders. Rocz Panstw Zakl Hig. 2015;66(3):189-94.
- Individual participant dataSharing planned: No
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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.
Hafiza Namra Khalid, MS-PPT principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Therapy and Nordic Walk 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 5 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric berg balance scale (time frame: Baseline, 6th week). 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 NCT06943508, 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 24 Apr 2025.