- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05227066
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
February 4, 2022 updated by: walaa eldesoukey heneidy, Delta University for Science and Technology
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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 Contact
- Name: walaa E. heneidy, PHD
- Phone Number: 00201227512697
- Email: walaa.eldesoukey@gmail.com
Study Contact Backup
- Name: mohamed A. behiry, PHD
- Phone Number: 00201005147878
- Email: Behirycenter@gmail.com
Study Locations
-
-
Dakahelia
-
Gamasa, Dakahelia, Egypt, 4030
- Recruiting
- Delta University for Science and Technology
-
Contact:
- Hala I. Kassem, Professor
- Phone Number: 002 01143686666
- Email: halakassem146@gmail.com
-
-
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
7 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ataxic cerebral palsy aged 7-13 years
Exclusion Criteria:
- any musculoskeletal conditions that affect balance previous surgeries that affecting balance
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: traditional physical therapy group
received traditional physical therapy protocol
|
traditional physical therapy group
|
Experimental: lower extremity weights group
received the same traditional physical therapy in addition to lower extremity weights
|
traditional physical therapy group
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in overall stability index
Time Frame: baseline and after 3 months of intervention.
|
change in overall stability index will measured by using biodex balance system
|
baseline and after 3 months of intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
antero-posterior stability index
Time Frame: baseline and after 3 months of intervention.
|
change in antero-posterior stability index will measured by using biodex balance system
|
baseline and after 3 months of intervention.
|
mediolateral stability index
Time Frame: baseline and after 3 months of intervention.
|
change in mediolateral stability index will measured by using biodex balance system
|
baseline and after 3 months of intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hala I. Kassem, Professor, Professor of physical therapy
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)
November 1, 2021
Primary Completion (Anticipated)
January 30, 2022
Study Completion (Anticipated)
February 10, 2022
Study Registration Dates
First Submitted
January 6, 2022
First Submitted That Met QC Criteria
February 4, 2022
First Posted (Actual)
February 7, 2022
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ataxic CP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.
Clinical Trials on Ataxic Cerebral Palsy
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St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Chaitanya Hospital, PuneUnknownAtaxic Infantile Cerebral PalsyIndia
-
Delta University for Science and TechnologyRecruitingAtaxic Cerebral PalsyEgypt
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
Clinical Trials on traditional physical therapy group
-
Isra UniversityUnknownCerebral Palsy, Spastic, DiplegicPakistan
-
Riphah International UniversityCompletedBackache, LowPakistan
-
Riphah International UniversityCompleted
-
Taif UniversityRecruitingAdhesive Capsulitis of ShoulderSaudi Arabia
-
University of Mississippi Medical CenterCompleted
-
Oregon Health and Science UniversityNorthWest Rehabilitations Associates; APDMUnknownStroke | Multiple Sclerosis | Parkinson Disease | Gait Disorders, Neurologic | Gait Disorder, Sensorimotor | Gait, Unsteady | Gait Ataxia | Gait, Stumbling | Gait, ShufflingUnited States
-
Grand Valley State UniversityMary Free Bed Rehabilitation HospitalCompletedHeadaches, TensionUnited States