Development DelayNCT05969808
Effects of Adapted Physical Activities on Visual Motor Integration in Children With Developmental Delay
A study testing baseline therapy and conventional therapy and baseline treatment and adaptive physical activity in people with Development Delay, run by Riphah International University at 1 site in Pakistan.
Trial summary
Developmental delay occurs when a child does not achieve developmental milestones in comparison to peers of the same age range. Children and adolescents with developmental delay often experience participation restrictions. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Development Delay
- What is being tested?
- baseline therapy and conventional therapy and baseline treatment and adaptive physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2023to 25 Oct 2023
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group 3-6 (both Gender Male \& Female) (39)
- Gross Motor Function Classification System, Level I
- \& II (45)
- Manual Ability Classification System (MACS) levels
- 1-3 (46)
- Pre assessed Developmental delayed.
Who cannot join
- Visually impaired Child
- Children with co-morbidities such as Epilepsy, Hydrocephalus
- Fractures, contractures or conflicting concurrent treatment impacting motor Functioning
- Children with significant cognitive impairments.
- Children who have received specific interventions targeting Visual motor integration, manual dexterity or intra-limb coordination
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Developmental delay occurs when a child does not achieve developmental milestones in comparison to peers of the same age range. Children and adolescents with developmental delay often experience participation restrictions. Visual motor integration (VMI) is the ability of the child's hands and eyes to work together to guide their movements. Visual motor integration is a broad term encompasses cognitive as well as manual domains. This study will focused on the Manual Dexterity and intra-limb coordination (VMI). And it will evaluate the effects of adaptive physical activity on Visual Motor Integration.
Adaptive physical activities (APAs) are exercises and games that have been specially designed to fulfil the unique needs and skills of special needs or developmental delays.
Read the detailed description
Randomized control trial will be conducted with sample size 30, used to compare the effectiveness of adaptive physical activity on visual motor integration in children with developmental delay. subjects with developmental delay meeting the predetermined inclusion and exclusion criteria will be divided into two groups using non-probability convenient sampling. pre and post assessment will be done by Box and Block Test, Box and Ball Test, Discrete horizontal finger tapping test, Discrete vertical finger tapping with ball and continuous Vertical tapping with ball. subjects in group A will receive Baseline therapy and conventional therapy and group B will receive baseline therapy and adaptive physical activity.
- Conditions
- Development Delay
- Being tested
- baseline therapy and conventional therapy, baseline treatment and adaptive physical activity
- Keywords
- Visual motor integration
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baseline therapy and conventional therapyOther
Also called control group
These activities included were warm-up activities, general playtime, basic gross motor activities, and free play with toys three times a week for 45 minutes for a period of 12 weeks.
baseline treatment and adaptive physical activityOther
Also called experimental group
The experimental group's intervention plan had the following 12 elements . Each of which was completed for 10 minutes with two-minute breaks. Warm-up activities, puzzles and manipulatives, e.g., interlocking blocks or shape sorting toys, Balloon Badminton, Obstacle course (crawl in Tunnel ), Peg board play, Tactile sensory bin exploration filled with sand, Ball roll and catch, Tracing shapes, Play dough and clay activities, Cutting and pasting.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The control group will participate in regular activities and routines typically provided to children with developmental delays. These activities may include general playtime, basic gross motor activities, and free play with toys for 3 times a week for 45mins for 12 weeks. The control group will not receive any specific intervention targeted at improving visual motor integration, manual dexterity, or intra-limb coordination.
Experimental group Receives: Other: baseline therapy and conventional therapy |
| experimental group | Active comparator | The Experimental group will receive the baseline treatment as Control group. Adaptive Physical Activities will perform for to improve Visual Motor Integration 3 times a week for 45mins for 12 weeks. Pre and post assessment will be performed by using box and boll test, box and block test, Discrete Vertical Finger Tapping Test (DVFTT), discrete horizontal finger tapping test and discrete vertical tapping test with ball. Receives: Other: baseline treatment and adaptive physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test (BBT)
A frequently used assessment test, the Box and Block Test, measure manual dexterity and functional ability, mainly in those with upper limb disabilities. This test measures the capacity to handle items and carry out tasks that call for fine motor abilities(47). 150 tiny wood cubic blocks (1-inch) plus a box with two compartments separated by a wooden wall make up the BBT. 2.5 cm wooden block on each side and a wooden box (53.7 x 25.4 cm) separated into two compartments by a wall 15.2 cm high were the materials used to evaluate the BB test. The BBT entails moving as many little blocks as possible, one at a time, from the compartment on the tested side to the other with the same hand, being careful to cross over the gap. The number of blocks that are correctly shifted in 60 seconds is used to calculate the score
Measured: 12 weeks
Box and ball test ( BBT)
The BBLT followed the same procedure as the BBTs. The sole modification was that the BBLT evaluated the quantity of boccia balls rather than blocks. Due to the size of the compartments, only six balls could fit inside at once. It will be necessary to have two researchers, one at each end of the table.
Measured: 12 weeks
discrete horizontal finger tapping test (DHFTT)
This test used to measure the intra-limb coordination of upper limb.Participants will sit on their chairs and will be placed parallel to a table, at 10 cm from the edge of the tapping plates. The table will be adjusted so that the bottom of the table will be aligned with the players' hips (greater trochanter), and the shoulders of the players' throwing arms with the plate A (start position). Participants will asked to place their non-throwing arm across their chest and keep their throwing hand closed with the index finger extended To complete the test, participants will need to complete 10 tapping cycles, reporting their performance as the average score of the 10 tapping cycles. A cycle was composed of the participants releasing from plate A to hit the plate B (finish position) as fast as possible. The plates were displaced horizontally, and the distance between both plates' centers was 30 cm. The metal plates were 30 cm long by 20 cm wide.
Measured: 12 weeks
Discrete vertical tapping test with ball
this test used to measure the intra-limb coordination. The plates will be arranged vertically in an "L" shape (90°), where plate A will be kept on horizontal but plate B will be placed on the vertical edge .The distance between both plates' centers will be 30 cm, like in the DHFTT, and the two tests will use the same protocol.
Measured: 12 weeks
continuous vertical tapping test with ball
this test used to measure the intra-limb coordination of upper limb. Participants will perform a continuous movement consisting of grasping the ball and hitting plates A and B alternatively as fast as possible within 1 min. Ball contact could be made on any part of the plates.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start10 Aug 2023
- Primary completion1 Oct 2023
- Study completion25 Oct 2023
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 Development DelayStudies 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
- Randomized control trial will be conducted with sample size 30, used to compare the effectiveness of adaptive physical activity on visual motor integration in children with developmental delay. subjects with developmental delay meeting the predetermined inclusion and exclusion criteria will be divided into two groups using non-probability convenient sampling. pre and post assessment will be done by Box and Block Test, Box and Ball Test, Discrete horizontal finger tapping test, Discrete vertical finger tapping with ball and continuous Vertical tapping with ball. subjects in group A will receive Baseline therapy and conventional therapy and group B will receive baseline therapy and adaptive physical activity.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laraib Batool, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969808
- Sponsor's protocol ID
- REC/ RCR & AHS/23/0726
- Status last verified
- Oct 2023
- First submitted
- 23 Jul 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zapata-Figueroa V, Ortiz-Corredor F. Assessment of Manual Abilities Using the Box and Block Test in Children with Bilateral Cerebral Palsy. Occup Ther Int. 2022 Feb 22;2022:9980523. doi: 10.1155/2022/9980523. eCollection 2022.
PubMed 35281716
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adapted Physical Activities on Visual Motor Integration in Children With Developmental Delay
- ClinicalTrials.gov ID
- NCT05969808
- Acronym / sponsor ID
- REC/ RCR & AHS/23/0726
- Conditions
- Development Delay
- Keywords
- Visual motor integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 1 Aug 2023 (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.
Developmental delay occurs when a child does not achieve developmental milestones in comparison to peers of the same age range. Children and adolescents with developmental delay often experience participation restrictions. Visual motor integration (VMI) is the ability of the child's hands and eyes to work together to guide their movements. Visual motor integration is a broad term encompasses cognitive as well as manual domains. This study will focused on the Manual Dexterity and intra-limb coordination (VMI). And it will evaluate the effects of adaptive physical activity on Visual Motor Integration.
Adaptive physical activities (APAs) are exercises and games that have been specially designed to fulfil the unique needs and skills of special needs or developmental delays.
Detailed description
Randomized control trial will be conducted with sample size 30, used to compare the effectiveness of adaptive physical activity on visual motor integration in children with developmental delay. subjects with developmental delay meeting the predetermined inclusion and exclusion criteria will be divided into two groups using non-probability convenient sampling. pre and post assessment will be done by Box and Block Test, Box and Ball Test, Discrete horizontal finger tapping test, Discrete vertical finger tapping with ball and continuous Vertical tapping with ball. subjects in group A will receive Baseline therapy and conventional therapy and group B will receive baseline therapy and adaptive physical activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial will be conducted with sample size 30, used to compare the effectiveness of adaptive physical activity on visual motor integration in children with developmental delay. subjects with developmental delay meeting the predetermined inclusion and exclusion criteria will be divided into two groups using non-probability convenient sampling. pre and post assessment will be done by Box and Block Test, Box and Ball Test, Discrete horizontal finger tapping test, Discrete vertical finger tapping with ball and continuous Vertical tapping with ball. subjects in group A will receive Baseline therapy and conventional therapy and group B will receive baseline therapy and adaptive physical activity.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: baseline therapy and conventional therapyThe control group will participate in regular activities and routines typically provided to children with developmental delays. These activities may include general playtime, basic gross motor activities, and free play with toys for 3 times a week for 45mins for 12 weeks. The control group will not receive any specific intervention targeted at improving visual motor integration, manual dexterity, or intra-limb coordination. Experimental group |
| experimental group | Active comparator | Other: baseline treatment and adaptive physical activityThe Experimental group will receive the baseline treatment as Control group. Adaptive Physical Activities will perform for to improve Visual Motor Integration 3 times a week for 45mins for 12 weeks. Pre and post assessment will be performed by using box and boll test, box and block test, Discrete Vertical Finger Tapping Test (DVFTT), discrete horizontal finger tapping test and discrete vertical tapping test with ball. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age group 3-6 (both Gender Male \& Female) (39)
- Gross Motor Function Classification System, Level I
- \& II (45)
- Manual Ability Classification System (MACS) levels
- 1-3 (46)
Key exclusion criteria (5 listed)
- Visually impaired Child
- Children with co-morbidities such as Epilepsy, Hydrocephalus
- Fractures, contractures or conflicting concurrent treatment impacting motor Functioning
- Children with significant cognitive impairments.
- Children who have received specific interventions targeting Visual motor integration, manual dexterity or intra-limb coordination
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 |
|---|---|---|
| baseline therapy and conventional therapyAlso: control groupThese activities included were warm-up activities, general playtime, basic gross motor activities, and free play with toys three times a week for 45 minutes for a period of 12 weeks. | Other | control group |
| baseline treatment and adaptive physical activityAlso: experimental groupThe experimental group's intervention plan had the following 12 elements . Each of which was completed for 10 minutes with two-minute breaks. Warm-up activities, puzzles and manipulatives, e.g., interlocking blocks or shape sorting toys, Balloon Badminton, Obstacle course (crawl in Tunnel ), Peg board play, Tactile sensory bin exploration filled with sand, Ball roll and catch, Tracing shapes, Play dough and clay activities, Cutting and pasting. | Other | experimental group |
Primary outcome
Box and Block Test (BBT)
Time frame: 12 weeks
A frequently used assessment test, the Box and Block Test, measure manual dexterity and functional ability, mainly in those with upper limb disabilities. This test measures the capacity to handle items and carry out tasks that call for fine motor abilities(47). 150 tiny wood cubic blocks (1-inch) plus a box with two compartments separated by a wooden wall make up the BBT. 2.5 cm wooden block on each side and a wooden box (53.7 x 25.4 cm) separated into two compartments by a wall 15.2 cm high were the materials used to evaluate the BB test. The BBT entails moving as many little blocks as possible, one at a time, from the compartment on the tested side to the other with the same hand, being careful to cross over the gap. The number of blocks that are correctly shifted in 60 seconds is used to calculate the score
Box and ball test ( BBT)
Time frame: 12 weeks
The BBLT followed the same procedure as the BBTs. The sole modification was that the BBLT evaluated the quantity of boccia balls rather than blocks. Due to the size of the compartments, only six balls could fit inside at once. It will be necessary to have two researchers, one at each end of the table.
discrete horizontal finger tapping test (DHFTT)
Time frame: 12 weeks
This test used to measure the intra-limb coordination of upper limb.Participants will sit on their chairs and will be placed parallel to a table, at 10 cm from the edge of the tapping plates. The table will be adjusted so that the bottom of the table will be aligned with the players' hips (greater trochanter), and the shoulders of the players' throwing arms with the plate A (start position). Participants will asked to place their non-throwing arm across their chest and keep their throwing hand closed with the index finger extended To complete the test, participants will need to complete 10 tapping cycles, reporting their performance as the average score of the 10 tapping cycles. A cycle was composed of the participants releasing from plate A to hit the plate B (finish position) as fast as possible. The plates were displaced horizontally, and the distance between both plates' centers was 30 cm. The metal plates were 30 cm long by 20 cm wide.
Discrete vertical tapping test with ball
Time frame: 12 weeks
this test used to measure the intra-limb coordination. The plates will be arranged vertically in an "L" shape (90°), where plate A will be kept on horizontal but plate B will be placed on the vertical edge .The distance between both plates' centers will be 30 cm, like in the DHFTT, and the two tests will use the same protocol.
continuous vertical tapping test with ball
Time frame: 12 weeks
this test used to measure the intra-limb coordination of upper limb. Participants will perform a continuous movement consisting of grasping the ball and hitting plates A and B alternatively as fast as possible within 1 min. Ball contact could be made on any part of the plates.
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 27 Oct 2023.
- Background: PubMed 35281716Zapata-Figueroa V, Ortiz-Corredor F. Assessment of Manual Abilities Using the Box and Block Test in Children with Bilateral Cerebral Palsy. Occup Ther Int. 2022 Feb 22;2022:9980523. doi: 10.1155/2022/9980523. eCollection 2022.
- 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.
Laraib Batool, MS 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 baseline therapy and conventional therapy and baseline treatment and adaptive physical activity in people with Development Delay, 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 6 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: finished, as of the sponsor's last update on 27 Oct 2023. 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?
Box and Block Test (BBT) (time frame: 12 weeks). The study lists 5 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 NCT05969808, 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 27 Oct 2023.