NCT06198114

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Visual ImpairmentMulti Sensory Integration

Outcome Measures

Primary Outcomes (4)

  • 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

  • HOYT'S FUNCTION TEST

    Hoyt's level of visual function used to determine visual functional level before starting treatment.

    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

    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

    8 weeks

Study Arms (2)

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.

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).

Other: Conventional Therapy

Interventions

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

Multi Sensory Integration

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.

Conventional Therapy

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

    PMID: 36010014BACKGROUND
  • 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.

    PMID: 26152053BACKGROUND

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Munawar, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations