Down SyndromeNCT04818437
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
A study testing BALANCE TRAINING and CORE STABILITY EXERCISES in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Children with Down syndrome often present with problems of posture \& balance and mobility. Balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for children with DS. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- BALANCE TRAINING and CORE STABILITY EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Trisomy 21 by genetic karyotype
- A confirmed diagnosis of Down syndrome by a paediatric neurologist, having no neurological or mobility disorders,
- independent standing and walking abilities,
- Joint Laxity , low muscle tone and psychomotor development deficits
- Normal vision and hearing
Who cannot join
- A history of congenital heart defects and orthopedic
- surgery in the past year and severe mental retardation.
- Seizure
- Severe visual or auditory disturbances,
- Weight less than the 3rd percentile of Down syndrome
- Multiple sclerosis or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Children with Down syndrome often present with problems of posture \& balance and mobility. Balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for children with DS.
Objective: To determine the effect core stability exercises and balance training in postural control among Down syndrome.
Read the detailed description
This study was a randomized clinical trail. Children with Down Syndrome were determined on inclusion \& exclusion criteria. Children with Down syndrome were arbitrarily allocated into two groups with ages ranged from 5 to 17 years. The sample size was 20 patients. They were assigned randomly into two groups. Group 1 received balance training and Group 2 received core stability exercises. The duration of treatment was 6 weeks. Data is collected from Comprehensive Rehabilitation center Chakwal Postural stability was evaluated pre and post treatment by pediatric berg balance scale. Values which were obtained after this intervention were analyzed for any change using SPSS
- Conditions
- Down Syndrome
- Being tested
- BALANCE TRAINING, CORE STABILITY EXERCISES
- Keywords
- Down syndrome, Core stability, Postural Control, Pediatric Berg balance scale
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALANCE TRAININGOther
Trunk, head, and upper limbs rotation from kneeling. 2- Upper limbs flexion and extension with simultaneous head movement from kneeling. 3-Pelvic bridging followed by raising one lower limb and extending knee. 4-Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising of he right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed
CORE STABILITY EXERCISESOther
- Abdominal bracing while lying in supine position.
- Abdominal bracing with heel slide while lying in supine position.
- Abdominal bracing with Leg lifts while lying in supine position.
- Abdominal bracing with bridging while lying in supine position.
- Abdominal bracing while Standing.-Abdominal bracing while walking.
7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | Balance training
1. Trunk, head, and upper limbs rotation from kneeling.
2. Upper limbs flexion and extension with simultaneous head movement from kneeling.
3. Pelvic bridging followed by raising one lower limb and extending knee.
4. Lifting opposite upper and lower limbs from Quadruped position.
6-Heel and toe raises, alternate rising ofthe right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed Receives: Other: BALANCE TRAINING |
| Core stability exercise | Active comparator | Core stability exercises:
1. Abdominal bracing while lying in supine position.
2. Abdominal bracing with heel slide while lying in supine position.
3. Abdominal bracing with Leg lifts while lying in supine position.
4. Abdominal bracing with bridging while lying in supine position.
5. Abdominal bracing while Standing 6-Abdominal bracing while walking.
7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying. Receives: Other: CORE STABILITY EXERCISES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg balance scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in CP children . The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start15 Sep 2019
- Primary completion20 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PHD*, Principal investigator, Riphah international university lahore campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818437
- Sponsor's protocol ID
- REC/Lhr/19/1012 Hunza Zulfiqar
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
PubMed 31301057Eid MA, Aly SM, Huneif MA, Ismail DK. Effect of isokinetic training on muscle strength and postural balance in children with Down's syndrome. Int J Rehabil Res. 2017 Jun;40(2):127-133. doi: 10.1097/MRR.0000000000000218.
PubMed 28146007Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.
PubMed 32273655Sugimoto D, Bowen SL, Meehan WP 3rd, Stracciolini A. Effects of Neuromuscular Training on Children and Young Adults with Down Syndrome: Systematic Review and Meta-Analysis. Res Dev Disabil. 2016 Aug;55:197-206. doi: 10.1016/j.ridd.2016.04.003. Epub 2016 Apr 25.
PubMed 27123540Motealleh A, Mohamadi M, Moghadam MB, Nejati N, Arjang N, Ebrahimi N. Effects of Core Neuromuscular Training on Pain, Balance, and Functional Performance in Women With Patellofemoral Pain Syndrome: A Clinical Trial. J Chiropr Med. 2019 Mar;18(1):9-18. doi: 10.1016/j.jcm.2018.07.006. Epub 2019 Feb 10.
PubMed 31193229Maiano C, Hue O, Lepage G, Morin AJS, Tracey D, Moullec G. Do Exercise Interventions Improve Balance for Children and Adolescents With Down Syndrome? A Systematic Review. Phys Ther. 2019 May 1;99(5):507-518. doi: 10.1093/ptj/pzz012.
PubMed 31089706Capio CM, Mak TCT, Tse MA, Masters RSW. Fundamental movement skills and balance of children with Down syndrome. J Intellect Disabil Res. 2018 Mar;62(3):225-236. doi: 10.1111/jir.12458. Epub 2017 Dec 5.
PubMed 29205624Silva V, Campos C, Sa A, Cavadas M, Pinto J, Simoes P, Machado S, Murillo-Rodriguez E, Barbosa-Rocha N. Wii-based exercise program to improve physical fitness, motor proficiency and functional mobility in adults with Down syndrome. J Intellect Disabil Res. 2017 Aug;61(8):755-765. doi: 10.1111/jir.12384. Epub 2017 Jun 6.
PubMed 28585394Pena GM, Pavao SL, Oliveira MFP, Godoi D, de Campos AC, Rocha NACF. Dual-task effects on postural sway during sit-to-stand movement in children with Down syndrome. J Intellect Disabil Res. 2019 Jun;63(6):576-586. doi: 10.1111/jir.12599. Epub 2019 Jan 28.
PubMed 30687997Saquetto MB, Pereira FF, Queiroz RS, da Silva CM, Conceicao CS, Gomes Neto M. Effects of whole-body vibration on muscle strength, bone mineral content and density, and balance and body composition of children and adolescents with Down syndrome: a systematic review. Osteoporos Int. 2018 Mar;29(3):527-533. doi: 10.1007/s00198-017-4360-1. Epub 2018 Jan 12.
PubMed 29330572
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
- ClinicalTrials.gov ID
- NCT04818437
- Acronym / sponsor ID
- REC/Lhr/19/1012 Hunza Zulfiqar
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Core stability, Postural Control, Pediatric Berg balance scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 26 Mar 2021 (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.
Children with Down syndrome often present with problems of posture \& balance and mobility. Balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for children with DS.
Objective: To determine the effect core stability exercises and balance training in postural control among Down syndrome.
Detailed description
This study was a randomized clinical trail. Children with Down Syndrome were determined on inclusion \& exclusion criteria. Children with Down syndrome were arbitrarily allocated into two groups with ages ranged from 5 to 17 years. The sample size was 20 patients. They were assigned randomly into two groups. Group 1 received balance training and Group 2 received core stability exercises. The duration of treatment was 6 weeks. Data is collected from Comprehensive Rehabilitation center Chakwal Postural stability was evaluated pre and post treatment by pediatric berg balance scale. Values which were obtained after this intervention were analyzed for any change using SPSS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: BALANCE TRAININGBalance training 1. Trunk, head, and upper limbs rotation from kneeling. 2. Upper limbs flexion and extension with simultaneous head movement from kneeling. 3. Pelvic bridging followed by raising one lower limb and extending knee. 4. Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising ofthe right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed |
| Core stability exercise | Active comparator | Other: CORE STABILITY EXERCISESCore stability exercises: 1. Abdominal bracing while lying in supine position. 2. Abdominal bracing with heel slide while lying in supine position. 3. Abdominal bracing with Leg lifts while lying in supine position. 4. Abdominal bracing with bridging while lying in supine position. 5. Abdominal bracing while Standing 6-Abdominal bracing while walking. 7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Trisomy 21 by genetic karyotype
- A confirmed diagnosis of Down syndrome by a paediatric neurologist, having no neurological or mobility disorders,
- independent standing and walking abilities,
- Joint Laxity , low muscle tone and psychomotor development deficits
- Normal vision and hearing
Key exclusion criteria (6 listed)
- A history of congenital heart defects and orthopedic
- surgery in the past year and severe mental retardation.
- Seizure
- Severe visual or auditory disturbances,
- Weight less than the 3rd percentile of Down syndrome
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 |
|---|---|---|
| BALANCE TRAININGTrunk, head, and upper limbs rotation from kneeling. 2- Upper limbs flexion and extension with simultaneous head movement from kneeling. 3-Pelvic bridging followed by raising one lower limb and extending knee. 4-Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising of he right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed | Other | Balance training |
| CORE STABILITY EXERCISES1. Abdominal bracing while lying in supine position. 2. Abdominal bracing with heel slide while lying in supine position. 3. Abdominal bracing with Leg lifts while lying in supine position. 4. Abdominal bracing with bridging while lying in supine position. 5. Abdominal bracing while Standing.-Abdominal bracing while walking. 7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying | Other | Core stability exercise |
Primary outcome
Pediatric Berg balance scale
Time frame: 2 months
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in CP children . The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 31301057Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
- Background: PubMed 28146007Eid MA, Aly SM, Huneif MA, Ismail DK. Effect of isokinetic training on muscle strength and postural balance in children with Down's syndrome. Int J Rehabil Res. 2017 Jun;40(2):127-133. doi: 10.1097/MRR.0000000000000218.
- Background: PubMed 32273655Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.
- Background: PubMed 27123540Sugimoto D, Bowen SL, Meehan WP 3rd, Stracciolini A. Effects of Neuromuscular Training on Children and Young Adults with Down Syndrome: Systematic Review and Meta-Analysis. Res Dev Disabil. 2016 Aug;55:197-206. doi: 10.1016/j.ridd.2016.04.003. Epub 2016 Apr 25.
- Background: PubMed 31193229Motealleh A, Mohamadi M, Moghadam MB, Nejati N, Arjang N, Ebrahimi N. Effects of Core Neuromuscular Training on Pain, Balance, and Functional Performance in Women With Patellofemoral Pain Syndrome: A Clinical Trial. J Chiropr Med. 2019 Mar;18(1):9-18. doi: 10.1016/j.jcm.2018.07.006. Epub 2019 Feb 10.
- Background: PubMed 31089706Maiano C, Hue O, Lepage G, Morin AJS, Tracey D, Moullec G. Do Exercise Interventions Improve Balance for Children and Adolescents With Down Syndrome? A Systematic Review. Phys Ther. 2019 May 1;99(5):507-518. doi: 10.1093/ptj/pzz012.
- Background: PubMed 29205624Capio CM, Mak TCT, Tse MA, Masters RSW. Fundamental movement skills and balance of children with Down syndrome. J Intellect Disabil Res. 2018 Mar;62(3):225-236. doi: 10.1111/jir.12458. Epub 2017 Dec 5.
- Background: PubMed 28585394Silva V, Campos C, Sa A, Cavadas M, Pinto J, Simoes P, Machado S, Murillo-Rodriguez E, Barbosa-Rocha N. Wii-based exercise program to improve physical fitness, motor proficiency and functional mobility in adults with Down syndrome. J Intellect Disabil Res. 2017 Aug;61(8):755-765. doi: 10.1111/jir.12384. Epub 2017 Jun 6.
- Background: PubMed 30687997Pena GM, Pavao SL, Oliveira MFP, Godoi D, de Campos AC, Rocha NACF. Dual-task effects on postural sway during sit-to-stand movement in children with Down syndrome. J Intellect Disabil Res. 2019 Jun;63(6):576-586. doi: 10.1111/jir.12599. Epub 2019 Jan 28.
- Background: PubMed 29330572Saquetto MB, Pereira FF, Queiroz RS, da Silva CM, Conceicao CS, Gomes Neto M. Effects of whole-body vibration on muscle strength, bone mineral content and density, and balance and body composition of children and adolescents with Down syndrome: a systematic review. Osteoporos Int. 2018 Mar;29(3):527-533. doi: 10.1007/s00198-017-4360-1. Epub 2018 Jan 12.
- 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. This study is not recruiting at the moment.
Binash Afzal, PHD* principal investigator
Riphah international university lahore campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALANCE TRAINING and CORE STABILITY EXERCISES 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 6 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: finished, as of the sponsor's last update on 30 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Berg balance scale (time frame: 2 months). 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 NCT04818437, which also lists 10 linked publications.
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 30 Mar 2021.