Developmental Coordination DisorderNCT04694352
Trampoline Exercises Children With Developmental Coordination Disorder
A study testing Jumping Exercises and Conventional Physical therapy in people with Developmental Coordination Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
RCT in which 28 children with developmental coordination disorder (DCD) were enrolled and equally distributed into two groups; Participants in control group were treated with conventional physical therapy while experimental were given conventional physical therapy in addition to trampoline exercises. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Jumping Exercises and Conventional Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2020to 30 Nov 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with DCD indicated using DCDQ.
Who cannot join
- No developmental coordination disorder
- declined to participate
- Progressive unstable health condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Trampoline Exercises Children With Developmental Coordination Disorder
RCT in which 28 children with developmental coordination disorder (DCD) were enrolled and equally distributed into two groups; Participants in control group were treated with conventional physical therapy while experimental were given conventional physical therapy in addition to trampoline exercises. Assessment was at 0, 4 and 8 week using developmental coordination disorder questionnaire (DCDQ), pediatric balance scale (PBS) and peads quality of life (PQL)
- Conditions
- Developmental Coordination Disorder
- Being tested
- Jumping Exercises, Conventional Physical therapy
- Keywords
- Balance, Developmental coordination disorder, Motor Activity, Quality of Life
- Medical subject headings
- Motor Skills Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumping ExercisesOther
Jumping in place Jump and clap Jump and reach Jump and twist Jump and turn Half jumping jack Jumping side to side Each exercise done for 1 minute, 5 repetitions is session of 1 hour 15minutes
Conventional Physical therapyOther
Drop and catch a ball Squeeze ball between legs, jump up and catch the ball Walking on a straight line Stand on one leg try to pick object from floor without using hands (do this on both legs) Drop the ball and catch it with both hands Jump up stair with both limbs off the floor simultaneously while holding railing.
Skipping. At least 5 repetitions for each exercise in session of total 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Jumping Exercises | Experimental | Jumping in place Jump and clap Jump and reach Jump and twist Jump and turn Half jumping jack Jumping side to side Receives: Other: Jumping Exercises |
| Conventional | Active comparator | Drop and catch a ball Squeeze ball between legs, jump up and catch the ball Walking on a straight line Stand on one leg try to pick object from floor without using hands (do this on both legs) Drop the ball and catch it with both hands Jump up stair with both limbs off the floor simultaneously while holding railing.
Skipping. Receives: Other: Conventional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental coordination disorder questionnaire (DCDQ)
Developmental Coordination Questionnaire (DCDQ) is a scale to diagnose 5 to 15 year children with DCD and measure their developmental features but through parents reporting, Parents are asked to compare functional task and motor activity of their children with other children
Measured: 8 weeks
Pediatric balance scale (PBS)
Pediatric Balance Scale (PBS) is a scale used to assess child's balance. It is fourteen item scale same as Berg Balance scale.
Measured: 8 weeks
Peads quality of life (PQL)
The Peads quality of life (PQL) Measurement Model is scale for measuring health related quality of life (HRQOL) in children. It has excellent reliability of 0.88 and found measure quality of life in children ranging from healthy to chronic health conditions
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start30 Aug 2020
- Primary completion28 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694352
- Sponsor's protocol ID
- REC00662 Maryam Suleman
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitsiou M, Giagazoglou P, Sidiropoulou M, Kotsikas G, Tsimaras V, Fotiadou E. Static balance ability in children with developmental coordination disorder. European Journal of Physical Education and Sport. 2016;11:17-23.
de Oliveira IS, da Silva Oliveira D, de Azevedo Guendler J, Rocha BM, Sarinho SW. Effectiveness of motor intervention on children with Developmental Coordination Disorder (DCD): A systematic review. Journal of Physical Education and Sport Management. 2017;8(3):32-40.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trampoline Exercises Children With Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT04694352
- Acronym / sponsor ID
- REC00662 Maryam Suleman
- Conditions
- Developmental Coordination Disorder
- Keywords
- Balance, Developmental coordination disorder, Motor Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 5 Jan 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.
RCT in which 28 children with developmental coordination disorder (DCD) were enrolled and equally distributed into two groups; Participants in control group were treated with conventional physical therapy while experimental were given conventional physical therapy in addition to trampoline exercises. Assessment was at 0, 4 and 8 week using developmental coordination disorder questionnaire (DCDQ), pediatric balance scale (PBS) and peads quality of life (PQL)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jumping Exercises | Experimental | Other: Jumping ExercisesJumping in place Jump and clap Jump and reach Jump and twist Jump and turn Half jumping jack Jumping side to side |
| Conventional | Active comparator | Other: Conventional Physical therapyDrop and catch a ball Squeeze ball between legs, jump up and catch the ball Walking on a straight line Stand on one leg try to pick object from floor without using hands (do this on both legs) Drop the ball and catch it with both hands Jump up stair with both limbs off the floor simultaneously while holding railing. Skipping. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with DCD indicated using DCDQ.
Key exclusion criteria (3 listed)
- No developmental coordination disorder
- declined to participate
- Progressive unstable health condition.
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 |
|---|---|---|
| Jumping ExercisesJumping in place Jump and clap Jump and reach Jump and twist Jump and turn Half jumping jack Jumping side to side Each exercise done for 1 minute, 5 repetitions is session of 1 hour 15minutes | Other | Jumping Exercises |
| Conventional Physical therapyDrop and catch a ball Squeeze ball between legs, jump up and catch the ball Walking on a straight line Stand on one leg try to pick object from floor without using hands (do this on both legs) Drop the ball and catch it with both hands Jump up stair with both limbs off the floor simultaneously while holding railing. Skipping. At least 5 repetitions for each exercise in session of total 1 hour | Other | Conventional |
Primary outcome
Developmental coordination disorder questionnaire (DCDQ)
Time frame: 8 weeks
Developmental Coordination Questionnaire (DCDQ) is a scale to diagnose 5 to 15 year children with DCD and measure their developmental features but through parents reporting, Parents are asked to compare functional task and motor activity of their children with other children
Pediatric balance scale (PBS)
Time frame: 8 weeks
Pediatric Balance Scale (PBS) is a scale used to assess child's balance. It is fourteen item scale same as Berg Balance scale.
Peads quality of life (PQL)
Time frame: 8 weeks
The Peads quality of life (PQL) Measurement Model is scale for measuring health related quality of life (HRQOL) in children. It has excellent reliability of 0.88 and found measure quality of life in children ranging from healthy to chronic health conditions
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 5 Jan 2021.
- BackgroundMitsiou M, Giagazoglou P, Sidiropoulou M, Kotsikas G, Tsimaras V, Fotiadou E. Static balance ability in children with developmental coordination disorder. European Journal of Physical Education and Sport. 2016;11:17-23.
- Backgroundde Oliveira IS, da Silva Oliveira D, de Azevedo Guendler J, Rocha BM, Sarinho SW. Effectiveness of motor intervention on children with Developmental Coordination Disorder (DCD): A systematic review. Journal of Physical Education and Sport Management. 2017;8(3):32-40.
- Individual participant dataSharing planned: No
Related trials for Developmental Coordination Disorder
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitation
BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Depression, Anxiety
Not yet recruiting
Video-Assisted Core Stabilization Exercises in Children With Developmental Coordination Disorder
Developmental Coordination Disorder (DCD)
Not yet recruitingObservational study
Wearable Sensor Toolkit for Infant Motor Development
Motor Delay, Infant Development
Not yet recruiting
Neuromotor Task Training in Autistic Children With Motor Difficulties
Autism Spectrum Disorder (ASD)
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.
Mirza Obaid Baig principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jumping Exercises and Conventional Physical therapy in people with Developmental Coordination Disorder, 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 1 inclusion and 3 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 5 Jan 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?
Developmental coordination disorder questionnaire (DCDQ) (time frame: 8 weeks). 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 NCT04694352, which also lists 2 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 5 Jan 2021.