Back to resultsEfficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Primary Purpose
Ataxic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
adding lower extremity weights
traditional physical therapy group
Sponsored by
About this trial
This is an interventional treatment trial for Ataxic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- ataxic cerebral palsy aged 7-13 years
Exclusion Criteria:
- any musculoskeletal conditions that affect balance previous surgeries that affecting balance
Sites / Locations
- Delta University for Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
traditional physical therapy group
lower extremity weights group
Arm Description
received traditional physical therapy protocol
received the same traditional physical therapy in addition to lower extremity weights
Outcomes
Primary Outcome Measures
Change in overall stability index
change in overall stability index will measured by using biodex balance system
Secondary Outcome Measures
antero-posterior stability index
change in antero-posterior stability index will measured by using biodex balance system
mediolateral stability index
change in mediolateral stability index will measured by using biodex balance system
Full Information
NCT ID
NCT05227066
First Posted
January 6, 2022
Last Updated
February 4, 2022
Sponsor
Delta University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05227066
Brief Title
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Official Title
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
February 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology
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
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional physical therapy group
Arm Type
Experimental
Arm Description
received traditional physical therapy protocol
Arm Title
lower extremity weights group
Arm Type
Experimental
Arm Description
received the same traditional physical therapy in addition to lower extremity weights
Intervention Type
Other
Intervention Name(s)
adding lower extremity weights
Intervention Description
All children in the two groups received physical therapy protocol for 30 minutes in addition to half kg of sandbags weights attached for each leg
Intervention Type
Other
Intervention Name(s)
traditional physical therapy group
Intervention Description
traditional physical therapy group
Primary Outcome Measure Information:
Title
Change in overall stability index
Description
change in overall stability index will measured by using biodex balance system
Time Frame
baseline and after 3 months of intervention.
Secondary Outcome Measure Information:
Title
antero-posterior stability index
Description
change in antero-posterior stability index will measured by using biodex balance system
Time Frame
baseline and after 3 months of intervention.
Title
mediolateral stability index
Description
change in mediolateral stability index will measured by using biodex balance system
Time Frame
baseline and after 3 months of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ataxic cerebral palsy aged 7-13 years
Exclusion Criteria:
any musculoskeletal conditions that affect balance previous surgeries that affecting balance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
walaa E. heneidy, PHD
Phone
00201227512697
Email
walaa.eldesoukey@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed A. behiry, PHD
Phone
00201005147878
Email
Behirycenter@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala I. Kassem, Professor
Organizational Affiliation
Professor of physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
Delta University for Science and Technology
City
Gamasa
State/Province
Dakahelia
ZIP/Postal Code
4030
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala I. Kassem, Professor
Phone
002 01143686666
Email
halakassem146@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
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