Back to resultsEffect of Sensory Integration Therapy on Balance and Functional Mobility
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Selected physical therapy program
Modified physical therapy program to increase sensory input
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria: Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system Exclusion Criteria: Visual or auditory problems. Fixed deformities of lower limbs.
Sites / Locations
- Faculty of physical therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
received a modified selected physical therapy program to increase sensory input.
received a selected physical therapy
Outcomes
Primary Outcome Measures
Assessment of balance
Assessment by using Biodex Balance System
Assessment of functional mobility
Assessment by using the Timed Up and Go test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05614713
Brief Title
Effect of Sensory Integration Therapy on Balance and Functional Mobility
Official Title
Effect of Sensory Integration Therapy on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test.
Detailed Description
Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test. The control group received selected physical therapy, while the study group received the previously mentioned selected physical therapy program modified to increase sensory input. Treatment sessions for both groups were conducted for both groups for 1 hour once a day, three times per week for two successive months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
study group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
received a modified selected physical therapy program to increase sensory input.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
received a selected physical therapy
Intervention Type
Procedure
Intervention Name(s)
Selected physical therapy program
Intervention Description
Gait training and balance training
Intervention Type
Procedure
Intervention Name(s)
Modified physical therapy program to increase sensory input
Intervention Description
Gait training and balance training using sensory stimulating matts
Primary Outcome Measure Information:
Title
Assessment of balance
Description
Assessment by using Biodex Balance System
Time Frame
After 2 months of intervention
Title
Assessment of functional mobility
Description
Assessment by using the Timed Up and Go test
Time Frame
After 2 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system
Exclusion Criteria:
Visual or auditory problems. Fixed deformities of lower limbs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai E Abbass, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of physical therapy, Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Sensory Integration Therapy on Balance and Functional Mobility
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