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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06198114
Other study ID # REC/RCR&AHS/23/0746
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date February 5, 2024

Study information

Verified date January 2024
Source Riphah International University
Contact Imran Amjad, PhD
Phone 9233224390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Multi Sensory Therapy
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 Therapy
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.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

Gori 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 weeks
Primary HOYT'S FUNCTION TEST Hoyt's level of visual function used to determine visual functional level before starting treatment. 8 weeks
Primary 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 8 weeks
Primary 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 8 weeks
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