Down SyndromeNCT04816409
Effect of Neuro Developmental Therapy in Infants With Down Syndrome
A study testing conventional therapy and Neurodevelopmental therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Neurodevelopmental treatments are a progressive therapeutic method experienced thru qualified therapists for the improvement in affected ones. The most important trial in Down syndrome children is motor milestones and postural reactions to develop on time. Read more about this study
- Who is it for?
- Ages 5 months to 3 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- conventional therapy and Neurodevelopmental therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2019to 30 Jan 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 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Trisomy 21 by genetic karyotype.
- Down syndrome children with delayed milestone.
- Definite identification of Down syndrome by neurologist.
- Children having the average birth weight above 2.500 grams and average birth length above 49.52 cm.
- Laxity, low muscle tone and psychomotor development deficits
Who cannot join
- Infants with Heart Defect.
- Seizure.
- Critical orthopedic difficulties or deformities (hip instability, patellar instability, foot deformity).
- Unrestrained thyroid conflicts.
- Perilabour asphyxia (Apgar of minutes 1 and 5 equal to or less than 7).
- Critical optical or acoustic disorders.
- Mass below the 3rd percentage of Down syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuro Developmental Therapy to Improve Postural Reactions and Motor Milestones in Infants With Down Syndrome
Neurodevelopmental treatments are a progressive therapeutic method experienced thru qualified therapists for the improvement in affected ones. The most important trial in Down syndrome children is motor milestones and postural reactions to develop on time.
Neurodevelopmental therapy is applied to accurate atypical postural tone and to enable further regular motion for execution of presentation of abilities. Objective: To determine the effects of Neuro Developmental therapy in improving postural reaction and motor milestones in infants with Down syndrome.
Read the detailed description
This study was a randomized trial design. This study was conducted in Rehab Care Physiotherapy Department. 20 Children with Down syndrome meeting the predetermined inclusive and exclusive criteria were arbitrarily allocated into dual batches through convenient sampling technique. The first batch which was the experimental group was given Neurodevelopmental therapy and the duration of the treatment comprised of 1.5 hour, three days a week for 6 weeks. The second group which was the control group received conventional therapy and the period of the ministrations comprised of 1 hour, with 10 repetition 3 sets for each muscle three days a week for 1.5 months, Pre-assessment and post-assessment was evaluated through Gross motor function-88. Recorded values were analyzed through SPSS.
- Conditions
- Down Syndrome
- Being tested
- conventional therapy, Neurodevelopmental therapy
- Keywords
- Down syndrome, Children, Gross motor function, Neurodevelopmental treatment, Rehabilitation, Milestones, Postural reactions
- 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
Range of motion and Resistance training Linear actions are used to regularize extensor muscle tone (Neck extensors, back extensors hip extensors, knee extensors).(49) Postural control exercises Bouncing on gym ball in sitting, kneeling, or standing
- Linear swinging using a platform and swing, glider, hammock, and barrel; swinging in the kneeling, standing, sitting,
Neurodevelopmental therapyOther
Starting Posture
- Start and evaluate the supreme effective posture to move from(usually straight)
- Reassemble to mid plane (head/trunk)
- Neutral position of body (47) Identify the Missing Components Detect starting posture and compare to normal.(47)
Neurodevelopmental therapy application :
Tonic postural extensor muscle strengthening:
Push-pull scooter board games contrary to resistive tubing strips.(48) 2. Developmental movement patterns training: Obstacle crawl, hold swing's ropes in kneeling and half kneeling position, throw balls to aim kneeling and standing position. Manual Cues .Use hands on key points of control to assist normal posture, movement and prevent abnormal posture and movement. Balance and corrective reactions was established by means of ball and tilt board after the development of the skill of
li
| Study group | Role | What they receive |
|---|---|---|
| (Neurodevelopmental therapy) | Experimental | Starting Posture Start and evaluate the supreme effective posture to move from(usually straight) Reassemble to mid plane (head/trunk)
•Neutral position of body Identify the Missing Components Detect starting posture and compare to normal.
Neurodevelopmental therapy application :
Tonic postural extensor muscle strengthening:
Push-pull scooter board games contrary to resistive tubing strips.
Developmental movement patterns training:
Obstacle crawl, hold swing's ropes in kneeling anhalf kneeling position, throw balls to aim kneeling and standing position. Manual Cues .Use hands on key points of control to assist normal posture, movement and prevent abnormal posture and movement. Balance and corrective reactions was established by means of ball and tilt board after the development of the skill of sustaining exercise positions in children.4. Ambulation training, suitable to the motor Receives: Other: Neurodevelopmental therapy |
| Conventional treatment | Active comparator | Range of motion and Resistance training Linear actions are used to regularize extensor muscle tone (Neck extensors, back extensors hip extensors, knee extensors).(49) Postural control exercises Bouncing on gym ball in sitting, kneeling, or standing Linear swinging using a platform and swing, glider, hammock, and barrel; swinging in the kneeling, standing, sitting, Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88(GMFM-88)
The GMFM-88 is the original 88-item measure. Items span the spectrum of gross motor activities in five dimensions. ... The GMFM-66 is a 66 item subset of the original 88 items identified through Rasch analysis to best describe the gross motor function of children with cerebral palsy of varying abilities.
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 posted25 Mar 2021
- Study start15 Mar 2019
- Primary completion20 Nov 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Participant
- 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
- NCT04816409
- Sponsor's protocol ID
- REC/Lhr/19/1010 Raneem sajjad
- 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
Angsupaisal M, Dijkstra LJ, la Bastide-van Gemert S, van Hoorn JF, Burger K, Maathuis CGB, Hadders-Algra M. Best seating condition in children with spastic cerebral palsy: One type does not fit all. Res Dev Disabil. 2017 Dec;71:42-52. doi: 10.1016/j.ridd.2017.09.016. Epub 2017 Oct 5.
PubMed 28987971Valentin-Gudiol M, Mattern-Baxter K, Girabent-Farres M, Bagur-Calafat C, Hadders-Algra M, Angulo-Barroso RM. Treadmill interventions in children under six years of age at risk of neuromotor delay. Cochrane Database Syst Rev. 2017 Jul 29;7(7):CD009242. doi: 10.1002/14651858.CD009242.pub3.
PubMed 28755534Mura G, Carta MG, Sancassiani F, Machado S, Prosperini L. Active exergames to improve cognitive functioning in neurological disabilities: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Jun;54(3):450-462. doi: 10.23736/S1973-9087.17.04680-9. Epub 2017 Oct 25.
PubMed 29072042O'Callaghan FJ, Edwards SW, Alber FD, Hancock E, Johnson AL, Kennedy CR, Likeman M, Lux AL, Mackay M, Mallick AA, Newton RW, Nolan M, Pressler R, Rating D, Schmitt B, Verity CM, Osborne JP; participating investigators. Safety and effectiveness of hormonal treatment versus hormonal treatment with vigabatrin for infantile spasms (ICISS): a randomised, multicentre, open-label trial. Lancet Neurol. 2017 Jan;16(1):33-42. doi: 10.1016/S1474-4422(16)30294-0. Epub 2016 Nov 10.
PubMed 27838190Armstrong D, Said RR. Outcomes of High-Dose Steroid Therapy for Infantile Spasms in Children With Trisomy 21. J Child Neurol. 2019 Oct;34(11):646-652. doi: 10.1177/0883073819850650. Epub 2019 May 22.
PubMed 31113280Alsakhawi 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 31301057Savardi A, Borgogno M, Narducci R, La Sala G, Ortega JA, Summa M, Armirotti A, Bertorelli R, Contestabile A, De Vivo M, Cancedda L. Discovery of a Small Molecule Drug Candidate for Selective NKCC1 Inhibition in Brain Disorders. Chem. 2020 Aug 6;6(8):2073-2096. doi: 10.1016/j.chempr.2020.06.017.
PubMed 32818158
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 Neuro Developmental Therapy to Improve Postural Reactions and Motor Milestones in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT04816409
- Acronym / sponsor ID
- REC/Lhr/19/1010 Raneem sajjad
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Children, Gross motor function, Neurodevelopmental treatment, Rehabilitation, Milestones, Postural reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 25 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.
Neurodevelopmental treatments are a progressive therapeutic method experienced thru qualified therapists for the improvement in affected ones. The most important trial in Down syndrome children is motor milestones and postural reactions to develop on time.
Neurodevelopmental therapy is applied to accurate atypical postural tone and to enable further regular motion for execution of presentation of abilities. Objective: To determine the effects of Neuro Developmental therapy in improving postural reaction and motor milestones in infants with Down syndrome.
Detailed description
This study was a randomized trial design. This study was conducted in Rehab Care Physiotherapy Department. 20 Children with Down syndrome meeting the predetermined inclusive and exclusive criteria were arbitrarily allocated into dual batches through convenient sampling technique. The first batch which was the experimental group was given Neurodevelopmental therapy and the duration of the treatment comprised of 1.5 hour, three days a week for 6 weeks. The second group which was the control group received conventional therapy and the period of the ministrations comprised of 1 hour, with 10 repetition 3 sets for each muscle three days a week for 1.5 months, Pre-assessment and post-assessment was evaluated through Gross motor function-88. Recorded values were analyzed through SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Neurodevelopmental therapy) | Experimental | Other: Neurodevelopmental therapyStarting Posture Start and evaluate the supreme effective posture to move from(usually straight) Reassemble to mid plane (head/trunk) •Neutral position of body Identify the Missing Components Detect starting posture and compare to normal. Neurodevelopmental therapy application : Tonic postural extensor muscle strengthening: Push-pull scooter board games contrary to resistive tubing strips. Developmental movement patterns training: Obstacle crawl, hold swing's ropes in kneeling anhalf kneeling position, throw balls to aim kneeling and standing position. Manual Cues .Use hands on key points of control to assist normal posture, movement and prevent abnormal posture and movement. Balance and corrective reactions was established by means of ball and tilt board after the development of the skill of sustaining exercise positions in children.4. Ambulation training, suitable to the motor |
| Conventional treatment | Active comparator | Other: conventional therapyRange of motion and Resistance training Linear actions are used to regularize extensor muscle tone (Neck extensors, back extensors hip extensors, knee extensors).(49) Postural control exercises Bouncing on gym ball in sitting, kneeling, or standing Linear swinging using a platform and swing, glider, hammock, and barrel; swinging in the kneeling, standing, sitting, |
Who may qualify
- Ages
- 5 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Trisomy 21 by genetic karyotype.
- Down syndrome children with delayed milestone.
- Definite identification of Down syndrome by neurologist.
- Children having the average birth weight above 2.500 grams and average birth length above 49.52 cm.
- Laxity, low muscle tone and psychomotor development deficits
Key exclusion criteria (7 listed)
- Infants with Heart Defect.
- Seizure.
- Critical orthopedic difficulties or deformities (hip instability, patellar instability, foot deformity).
- Unrestrained thyroid conflicts.
- Perilabour asphyxia (Apgar of minutes 1 and 5 equal to or less than 7).
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 therapyRange of motion and Resistance training Linear actions are used to regularize extensor muscle tone (Neck extensors, back extensors hip extensors, knee extensors).(49) Postural control exercises Bouncing on gym ball in sitting, kneeling, or standing - Linear swinging using a platform and swing, glider, hammock, and barrel; swinging in the kneeling, standing, sitting, | Other | Conventional treatment |
| Neurodevelopmental therapyStarting Posture * Start and evaluate the supreme effective posture to move from(usually straight) * Reassemble to mid plane (head/trunk) * Neutral position of body (47) Identify the Missing Components Detect starting posture and compare to normal.(47) Neurodevelopmental therapy application : Tonic postural extensor muscle strengthening: Push-pull scooter board games contrary to resistive tubing strips.(48) 2. Developmental movement patterns training: Obstacle crawl, hold swing's ropes in kneeling and half kneeling position, throw balls to aim kneeling and standing position. Manual Cues .Use hands on key points of control to assist normal posture, movement and prevent abnormal posture and movement. Balance and corrective reactions was established by means of ball and tilt board after the development of the skill of li | Other | (Neurodevelopmental therapy) |
Primary outcome
Gross Motor Function Measure-88(GMFM-88)
Time frame: 2 months
The GMFM-88 is the original 88-item measure. Items span the spectrum of gross motor activities in five dimensions. ... The GMFM-66 is a 66 item subset of the original 88 items identified through Rasch analysis to best describe the gross motor function of children with cerebral palsy of varying abilities.
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 28987971Angsupaisal M, Dijkstra LJ, la Bastide-van Gemert S, van Hoorn JF, Burger K, Maathuis CGB, Hadders-Algra M. Best seating condition in children with spastic cerebral palsy: One type does not fit all. Res Dev Disabil. 2017 Dec;71:42-52. doi: 10.1016/j.ridd.2017.09.016. Epub 2017 Oct 5.
- Background: PubMed 28755534Valentin-Gudiol M, Mattern-Baxter K, Girabent-Farres M, Bagur-Calafat C, Hadders-Algra M, Angulo-Barroso RM. Treadmill interventions in children under six years of age at risk of neuromotor delay. Cochrane Database Syst Rev. 2017 Jul 29;7(7):CD009242. doi: 10.1002/14651858.CD009242.pub3.
- Background: PubMed 29072042Mura G, Carta MG, Sancassiani F, Machado S, Prosperini L. Active exergames to improve cognitive functioning in neurological disabilities: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Jun;54(3):450-462. doi: 10.23736/S1973-9087.17.04680-9. Epub 2017 Oct 25.
- Background: PubMed 27838190O'Callaghan FJ, Edwards SW, Alber FD, Hancock E, Johnson AL, Kennedy CR, Likeman M, Lux AL, Mackay M, Mallick AA, Newton RW, Nolan M, Pressler R, Rating D, Schmitt B, Verity CM, Osborne JP; participating investigators. Safety and effectiveness of hormonal treatment versus hormonal treatment with vigabatrin for infantile spasms (ICISS): a randomised, multicentre, open-label trial. Lancet Neurol. 2017 Jan;16(1):33-42. doi: 10.1016/S1474-4422(16)30294-0. Epub 2016 Nov 10.
- Background: PubMed 31113280Armstrong D, Said RR. Outcomes of High-Dose Steroid Therapy for Infantile Spasms in Children With Trisomy 21. J Child Neurol. 2019 Oct;34(11):646-652. doi: 10.1177/0883073819850650. Epub 2019 May 22.
- 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 32818158Savardi A, Borgogno M, Narducci R, La Sala G, Ortega JA, Summa M, Armirotti A, Bertorelli R, Contestabile A, De Vivo M, Cancedda L. Discovery of a Small Molecule Drug Candidate for Selective NKCC1 Inhibition in Brain Disorders. Chem. 2020 Aug 6;6(8):2073-2096. doi: 10.1016/j.chempr.2020.06.017.
- 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 conventional therapy and Neurodevelopmental therapy 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 7 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?
Gross Motor Function Measure-88(GMFM-88) (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 NCT04816409, which also lists 7 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.