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

The Effect of Sensory Integration Balance Training Compared With Traditional Balance Training for Children With Acquired Brain Injury (ABI)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Children With Acquired Brain Injury
• Intervention / Treatment: Other: Sensory integration therapy for balance and gait training; Other: Traditional Physiotherapy for balance and gait training

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Abdullah bin Abdulaziz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensory integration therapy for balance and gait; Sensory integration walking pathway with obstacles x 10 and standing on one leg with eyes open and eyes closed 5-10 sec	Other: Sensory integration therapy for balance and gait training; Sensory integartion Walking pathway with obstacles x10 rep, standing on one leg with eyes op5-10 sec x10 rep); Other: Traditional Physiotherapy for balance and gait training; Traditional Physiotherapy walking pathway with obstacles x10 rep, standing on one leg with eyes open 5-10 sec x10 rep
Active Comparator: Traditional Physiotherapy for balance and gait; Walking pathway with obstacles x 10 and standing on one leg with eyes open 5-10 sec	Other: Sensory integration therapy for balance and gait training; Sensory integartion Walking pathway with obstacles x10 rep, standing on one leg with eyes op5-10 sec x10 rep); Other: Traditional Physiotherapy for balance and gait training; Traditional Physiotherapy walking pathway with obstacles x10 rep, standing on one leg with eyes open 5-10 sec x10 rep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One week before and after training then one month after training
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	One week before and after training then one month after training
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.	One week before and after training then one month after training
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.	One week before and after training then one month after training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 week before and after training then one month after training
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	one week before and after training then one month after training

Collaborators and Investigators

• Sponsor: Princess Nourah Bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: IRB log #22-0364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No