- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05614713
Effect of Sensory Integration Therapy on Balance and Functional Mobility
November 6, 2022 updated by: Mai Elsayed Abbass, Cairo University
Effect of Sensory Integration Therapy on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Faculty of Physical Therapy, Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
received a modified selected physical therapy program to increase sensory input.
|
Gait training and balance training using sensory stimulating matts
|
Active Comparator: Control group
received a selected physical therapy
|
Gait training and balance training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of balance
Time Frame: After 2 months of intervention
|
Assessment by using Biodex Balance System
|
After 2 months of intervention
|
Assessment of functional mobility
Time Frame: After 2 months of intervention
|
Assessment by using the Timed Up and Go test
|
After 2 months of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mai E Abbass, Ph.D., Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
February 1, 2022
Study Completion (Actual)
February 27, 2022
Study Registration Dates
First Submitted
November 6, 2022
First Submitted That Met QC Criteria
November 6, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
November 14, 2022
Last Update Submitted That Met QC Criteria
November 6, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003289
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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