The Effect of Sensory Integration Balance Training on Children With ABI

Sponsor
Princess Nourah Bint Abdulrahman University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06037044
Collaborator
(none)
50
1
2
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5.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Sensory integration therapy for balance and gait training
  • Other: Traditional Physiotherapy for balance and gait training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessor will be blinded to group allocation
Primary Purpose:
Treatment
Official Title:
The Effect of Sensory Integration Balance Training Compared With Traditional Balance Training for Children With Acquired Brain Injury (ABI)
Actual Study Start Date :
Sep 6, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pediatric balance scale (PBS) [One week before and after training then one month after training]

    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.

  2. Gross motor functional measure (GMFM) [One week before and after training then one month after training]

    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

  3. Timed up and go (TUG) [One week before and after training then one month after training]

    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.

  4. Obstacle Test [One week before and after training then one month after training]

    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

  1. The Pediatric Quality of Life Inventory (PedsQL) [one week before and after training then one month after training]

    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.

  2. One min sit to stand test (1-MSTST) [one week before and after training then one month after training]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 King abdullah bin abdulaziz university hospital Riyadh Saudi Arabia

Sponsors and Collaborators

  • Princess Nourah Bint Abdulrahman University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Afrah Almuwais, Assistant prof, Princess Nourah Bint Abdulrahman University
ClinicalTrials.gov Identifier:
NCT06037044
Other Study ID Numbers:
  • IRB log #22-0364
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023