Visual ImpairmentNCT06198114
Effects of Multi Sensory Integration on Visual Impaired Children
A study testing Multi Sensory Therapy and Conventional Therapy in people with Visual Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
Visual impairment is use to describe any kind of vision loss, whether it's someone who cannot see at all or someone who has partial vision loss. visual impairment is classified on the bases of visual acuity like mild, moderate, severe, profound, near total visual impairment, no light perception (NLP). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Multi Sensory Therapy and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and Female age from( 05 -12year)
- Children from a Special Education School
- Visual acuity is 20/200 and check by hytos visual function test(9).
- All participants are label with legally blind by an ophthalmologist.
- Experienced physician screened the all participants and gave the good remark for the participation in training program.
Who cannot join
- Other History of neurological or developmental disorders
- Medical conditions that may affect motor development
- Inability to follow instructions or participate in study tasks
- Incomplete data or missing information
- Factors that could affect the validity or generalizability of the study findings Illness or Infection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Multi Sensory Integration on Hand Manipulation in Children With Visual Impairements
Visual impairment is use to describe any kind of vision loss, whether it's someone who cannot see at all or someone who has partial vision loss. visual impairment is classified on the bases of visual acuity like mild, moderate, severe, profound, near total visual impairment, no light perception (NLP). Multisensory integration refers to a broad class of computations involving multiple sensory modalities in which information is integrated to produce an enhanced (or degraded) response.A Randomized control trail will be conducted at rising sun institute for disable children. Total sample size will be of 40 participants. After meeting the inclusion and exclusion criteria participants will be divided into two groups .Group A Control group will receive conventional therapy program. Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Group B will be treated with standard activity based therapy In which place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes, Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. Nine whole peg tests are used to measure fine dexterity in visual impaired children. Jebsen Taylor hand function test for quantify motor hand function test. Total time for treatment per session will 45 minutes and duration of treatment will be 12 weeks, four days a week.box and block test used to improve manual hand dexterity. Assessment will be taken pre treatment, mid treatment at 4th week and 8th week and post treatment after 12th week. Data will be analyzed by SPSS
Read the detailed description
Group(A)Will be treated with traditional therapy in which Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Encourage the students to use two hands in an organized manner to manipulate objects (e.g., grasp/release, twist/turn, rotate and examine, open/close, stack, nest).5 days a week for an hour/daily .Group(B)Will be treated with activity based training by place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes , Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. 5 days in a week.
- Conditions
- Visual Impairment
- Being tested
- Multi Sensory Therapy, Conventional Therapy
- Keywords
- Visual Impairment, Multi Sensory Integration
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi Sensory TherapyOther
This group will be treated with activity based training by place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes , Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. 5 days in a week
Conventional TherapyOther
This group will be treated with traditional therapy in which Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Encourage the students to use two hands in an organized manner to manipulate objects (e.g., grasp/release, twist/turn, rotate and examine, open/close, stack, nest).5 days a week for an hour/daily.
| Study group | Role | What they receive |
|---|---|---|
| Multi Sensory Integration | Experimental | This group will be treated with activity based training In which place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes , Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. Receives: Other: Multi Sensory Therapy |
| Conventional Therapy | Active comparator | This group will be treated with traditional therapy in which Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Encourage the students to use two hands in an organized manner to manipulate objects (e.g., grasp/release, twist/turn, rotate and examine, open/close, stack, nest). Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOX AND BLOCK TEST
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with visual impairment. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Higher score of transferring block into another box in 60 second determined the hand dexterity
Measured: 8 weeks
HOYT'S FUNCTION TEST
Hoyt's level of visual function used to determine visual functional level before starting treatment.
Measured: 8 weeks
JEBSEN TAYLOR HAND FUNCTION TEST:
The test includes tasks that assess fine hand motor function and functional tasks with and without weight. It consists of seven subtests, which are performed on time. We used different (nuts, bullets, heavy and light objects , different metals bottle cap) The score for the subtest is equal to the time in seconds required to complete the task, the maximum score for the subtest is 120. The total score is equal to the sum of points for all subtests and is calculated separately for each hand. The Higher the score, the better the child's hand function. Time will be 40 minutes with 2 Session Per week over the periods of 08 weeks
Measured: 8 weeks
NINE HOLE PEG TEST
The test includes task that asses fine hand motor function and functional tasks. In which we use different objects like Board (wood or plastic), container for the pegs ,9 pegs, stopwatch .Instruct the patient to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible, using only the hand being evaluated. Then, instruct the patient to remove the pegs from the holes, one by one, and replace them back into the container. The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch once the last peg is in the container. The number of seconds it takes for the patient to complete the test. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second
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 posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
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 Visual ImpairmentStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Munawar, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198114
- Sponsor's protocol ID
- REC/RCR&AHS/23/0746
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cemali M, Pekcetin S, Aki E. The Effectiveness of Sensory Integration Interventions on Motor and Sensory Functions in Infants with Cortical Vision Impairment and Cerebral Palsy: A Single Blind Randomized Controlled Trial. Children (Basel). 2022 Jul 27;9(8):1123. doi: 10.3390/children9081123.
PubMed 36010014Gori M. Multisensory Integration and Calibration in Children and Adults with and without Sensory and Motor Disabilities. Multisens Res. 2015;28(1-2):71-99. doi: 10.1163/22134808-00002478.
PubMed 26152053
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi Sensory Integration on Hand Manipulation in Children With Visual Impairements
- ClinicalTrials.gov ID
- NCT06198114
- Acronym / sponsor ID
- REC/RCR&AHS/23/0746
- Conditions
- Visual Impairment
- Keywords
- Visual Impairment, Multi Sensory Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (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.
Visual impairment is use to describe any kind of vision loss, whether it's someone who cannot see at all or someone who has partial vision loss. visual impairment is classified on the bases of visual acuity like mild, moderate, severe, profound, near total visual impairment, no light perception (NLP). Multisensory integration refers to a broad class of computations involving multiple sensory modalities in which information is integrated to produce an enhanced (or degraded) response.A Randomized control trail will be conducted at rising sun institute for disable children. Total sample size will be of 40 participants. After meeting the inclusion and exclusion criteria participants will be divided into two groups .Group A Control group will receive conventional therapy program. Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Group B will be treated with standard activity based therapy In which place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes, Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. Nine whole peg tests are used to measure fine dexterity in visual impaired children. Jebsen Taylor hand function test for quantify motor hand function test. Total time for treatment per session will 45 minutes and duration of treatment will be 12 weeks, four days a week.box and block test used to improve manual hand dexterity. Assessment will be taken pre treatment, mid treatment at 4th week and 8th week and post treatment after 12th week. Data will be analyzed by SPSS
Detailed description
Group(A)Will be treated with traditional therapy in which Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Encourage the students to use two hands in an organized manner to manipulate objects (e.g., grasp/release, twist/turn, rotate and examine, open/close, stack, nest).5 days a week for an hour/daily .Group(B)Will be treated with activity based training by place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes , Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. 5 days in a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi Sensory Integration | Experimental | Other: Multi Sensory TherapyThis group will be treated with activity based training In which place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes , Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. |
| Conventional Therapy | Active comparator | Other: Conventional TherapyThis group will be treated with traditional therapy in which Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Encourage the students to use two hands in an organized manner to manipulate objects (e.g., grasp/release, twist/turn, rotate and examine, open/close, stack, nest). |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male and Female age from( 05 -12year)
- Children from a Special Education School
- Visual acuity is 20/200 and check by hytos visual function test(9).
- All participants are label with legally blind by an ophthalmologist.
- Experienced physician screened the all participants and gave the good remark for the participation in training program.
Key exclusion criteria (5 listed)
- Other History of neurological or developmental disorders
- Medical conditions that may affect motor development
- Inability to follow instructions or participate in study tasks
- Incomplete data or missing information
- Factors that could affect the validity or generalizability of the study findings Illness or 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 |
|---|---|---|
| Multi Sensory TherapyThis group will be treated with activity based training by place different( nuts, screws, bullets, coins, paper clips, coloring ,scissor cutting with different shapes , Simulated feeding (by collecting beans with a spoon and transferring them into a container),transfer light and heavy weight objects into empty box. 5 days in a week | Other | Multi Sensory Integration |
| Conventional TherapyThis group will be treated with traditional therapy in which Place toys/objects inside and encourage the student to reach in and pull them out as well as put them back in. Give the student objects that can be put together and pulled apart. Encourage the students to use two hands in an organized manner to manipulate objects (e.g., grasp/release, twist/turn, rotate and examine, open/close, stack, nest).5 days a week for an hour/daily. | Other | Conventional Therapy |
Primary outcome
BOX AND BLOCK TEST
Time frame: 8 weeks
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with visual impairment. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Higher score of transferring block into another box in 60 second determined the hand dexterity
HOYT'S FUNCTION TEST
Time frame: 8 weeks
Hoyt's level of visual function used to determine visual functional level before starting treatment.
JEBSEN TAYLOR HAND FUNCTION TEST:
Time frame: 8 weeks
The test includes tasks that assess fine hand motor function and functional tasks with and without weight. It consists of seven subtests, which are performed on time. We used different (nuts, bullets, heavy and light objects , different metals bottle cap) The score for the subtest is equal to the time in seconds required to complete the task, the maximum score for the subtest is 120. The total score is equal to the sum of points for all subtests and is calculated separately for each hand. The Higher the score, the better the child's hand function. Time will be 40 minutes with 2 Session Per week over the periods of 08 weeks
NINE HOLE PEG TEST
Time frame: 8 weeks
The test includes task that asses fine hand motor function and functional tasks. In which we use different objects like Board (wood or plastic), container for the pegs ,9 pegs, stopwatch .Instruct the patient to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible, using only the hand being evaluated. Then, instruct the patient to remove the pegs from the holes, one by one, and replace them back into the container. The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch once the last peg is in the container. The number of seconds it takes for the patient to complete the test. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second
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 13 Jun 2024.
- Background: PubMed 36010014Cemali M, Pekcetin S, Aki E. The Effectiveness of Sensory Integration Interventions on Motor and Sensory Functions in Infants with Cortical Vision Impairment and Cerebral Palsy: A Single Blind Randomized Controlled Trial. Children (Basel). 2022 Jul 27;9(8):1123. doi: 10.3390/children9081123.
- Background: PubMed 26152053Gori M. Multisensory Integration and Calibration in Children and Adults with and without Sensory and Motor Disabilities. Multisens Res. 2015;28(1-2):71-99. doi: 10.1163/22134808-00002478.
- 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.
Maria Munawar, 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 Multi Sensory Therapy and Conventional Therapy in people with Visual Impairment, 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: finished, as of the sponsor's last update on 13 Jun 2024. 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 (time frame: 8 weeks). The study lists 4 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 NCT06198114, 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 13 Jun 2024.