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The Effect of Sensory Integration Balance Training on Children With ABI (ABI)

Primary Purpose

Children With Acquired Brain Injury

Status
Active
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Sensory integration therapy for balance and gait training
Traditional Physiotherapy for balance and gait training
Sponsored by
Princess Nourah Bint Abdulrahman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children With Acquired Brain Injury

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children with ABI, able to walk with or without assistance, GMFCS level I-III, aged 4-12 years old, with subjective symptoms of balance impairments, fear of falling and/or history of falls Exclusion Criteria: Botox injections or tendon release surgery in the past six months

Sites / Locations

  • King abdullah bin abdulaziz university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sensory integration therapy for balance and gait

Traditional Physiotherapy for balance and gait

Arm Description

Sensory integration walking pathway with obstacles x 10 and standing on one leg with eyes open and eyes closed 5-10 sec

Walking pathway with obstacles x 10 and standing on one leg with eyes open 5-10 sec

Outcomes

Primary Outcome Measures

Pediatric balance scale (PBS)
It was developed as a balance measure for children. The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the functional balance skills for school-age children with mild-to-moderate motor impairments. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. These items include moving from a seated to a standing position, moving from a standing position to a sitting position, transfer, standing without support, sitting without support, standing with eyes closed, standing with feet together, standing with one foot in front of the other, standing on one foot, rotating 360 degrees, turning to look back, picking up an object off the floor, placing alternate foot on step or footrest, and reaching forward with an extended arm.
Gross motor functional measure (GMFM)
It is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. It has 88 items to explore motor ability in five dimensions; lying and rolling, sitting, crawling and kneeling, standing, and walking, running and jumping
Timed up and go (TUG)
It is a simple evaluative test used to measure functional mobility and show how safely a patient can move around. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down while timing.
Obstacle Test
It is a timed walking test. Time is calculated while the child is walking stepping over two obstacles and walking around a basket. The pathway is 8.5 meter and the start and end lines are marked. Time is calculating as the child walking between the lines and accomplishing the obstacles. Hight of the obstacle is 15% of the child leg length, while the width is 10%. The basket was around 56 centimeters in width and 69.5 centimeters in length. The child should stand behind the start line and walk in a straight line then step over the obstacles, walk around one side of the basket then pass the end line.

Secondary Outcome Measures

The Pediatric Quality of Life Inventory (PedsQL)
It is a brief measure of health-related quality of life in children and young people. The measure is either Proxy Report or Self-Report. It has 23 items comprise four Generic Core Scales: physical functioning, emotional functioning, social functioning, school functioning.
One min sit to stand test (1-MSTST)
The 1-MSTST typically involves an armless chair and the performance of as many sit-to-stand actions as possible in 1 min without using the upper limbs

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
Princess Nourah Bint Abdulrahman University
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1. Study Identification

Unique Protocol Identification Number
NCT06037044
Brief Title
The Effect of Sensory Integration Balance Training on Children With ABI
Acronym
ABI
Official Title
The Effect of Sensory Integration Balance Training Compared With Traditional Balance Training for Children With Acquired Brain Injury (ABI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Nourah Bint Abdulrahman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aim to investagte the effectivness of sensory integartion balance training during gait training with obstecles and stimulation to different sensation, in comparission to gait training with obstecles without sensory stimulation among children with acuired brain injury

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Acquired Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessor will be blinded to group allocation
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensory integration therapy for balance and gait
Arm Type
Experimental
Arm Description
Sensory integration walking pathway with obstacles x 10 and standing on one leg with eyes open and eyes closed 5-10 sec
Arm Title
Traditional Physiotherapy for balance and gait
Arm Type
Active Comparator
Arm Description
Walking pathway with obstacles x 10 and standing on one leg with eyes open 5-10 sec
Intervention Type
Other
Intervention Name(s)
Sensory integration therapy for balance and gait training
Intervention Description
Sensory integartion Walking pathway with obstacles x10 rep, standing on one leg with eyes op5-10 sec x10 rep)
Intervention Type
Other
Intervention Name(s)
Traditional Physiotherapy for balance and gait training
Intervention Description
Traditional Physiotherapy walking pathway with obstacles x10 rep, standing on one leg with eyes open 5-10 sec x10 rep
Primary Outcome Measure Information:
Title
Pediatric balance scale (PBS)
Description
It was developed as a balance measure for children. The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the functional balance skills for school-age children with mild-to-moderate motor impairments. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. These items include moving from a seated to a standing position, moving from a standing position to a sitting position, transfer, standing without support, sitting without support, standing with eyes closed, standing with feet together, standing with one foot in front of the other, standing on one foot, rotating 360 degrees, turning to look back, picking up an object off the floor, placing alternate foot on step or footrest, and reaching forward with an extended arm.
Time Frame
One week before and after training then one month after training
Title
Gross motor functional measure (GMFM)
Description
It is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. It has 88 items to explore motor ability in five dimensions; lying and rolling, sitting, crawling and kneeling, standing, and walking, running and jumping
Time Frame
One week before and after training then one month after training
Title
Timed up and go (TUG)
Description
It is a simple evaluative test used to measure functional mobility and show how safely a patient can move around. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down while timing.
Time Frame
One week before and after training then one month after training
Title
Obstacle Test
Description
It is a timed walking test. Time is calculated while the child is walking stepping over two obstacles and walking around a basket. The pathway is 8.5 meter and the start and end lines are marked. Time is calculating as the child walking between the lines and accomplishing the obstacles. Hight of the obstacle is 15% of the child leg length, while the width is 10%. The basket was around 56 centimeters in width and 69.5 centimeters in length. The child should stand behind the start line and walk in a straight line then step over the obstacles, walk around one side of the basket then pass the end line.
Time Frame
One week before and after training then one month after training
Secondary Outcome Measure Information:
Title
The Pediatric Quality of Life Inventory (PedsQL)
Description
It is a brief measure of health-related quality of life in children and young people. The measure is either Proxy Report or Self-Report. It has 23 items comprise four Generic Core Scales: physical functioning, emotional functioning, social functioning, school functioning.
Time Frame
one week before and after training then one month after training
Title
One min sit to stand test (1-MSTST)
Description
The 1-MSTST typically involves an armless chair and the performance of as many sit-to-stand actions as possible in 1 min without using the upper limbs
Time Frame
one week before and after training then one month after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with ABI, able to walk with or without assistance, GMFCS level I-III, aged 4-12 years old, with subjective symptoms of balance impairments, fear of falling and/or history of falls Exclusion Criteria: Botox injections or tendon release surgery in the past six months
Facility Information:
Facility Name
King abdullah bin abdulaziz university hospital
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

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The Effect of Sensory Integration Balance Training on Children With ABI

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