- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04723641
Effect of Functional Training on Motor Performance
April 19, 2023 updated by: hanaa mohsen, Badr University
Effect of Functional Strength Training From Plantigrade Foot Position on Motor Performance in Children With Diplegia
The functional strength training is mainly dealt with anti-gravity muscles and aiming at maximal carry over in day to day activities.
The functional strength training can be given using resistance and it may be gravity, body weight, resistance bands and free weights.
The exercises are specific to the muscle or muscle groups recruited during the functional activities
Study Overview
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
- Hanaa
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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
7 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age ranged from 7 to 10 years old.
- The degree of spasticity ranged from grade 1 to 2 hypertonia according to Modified Ashwarth Scale (MAS)
- Level II and III on GMFCS-ER
- They were able to understand and follow verbal instructions
Exclusion Criteria:
- 1- visual or auditory problems. 2- Orthopedic surgery in the lower limb in the last 12 months before the study. 3- Fixed deformities in joints and bones of lower limbs. 4- Botox injection in the last six months before the study. 5- Children with any special medications affecting muscle functions (anti-spastic drugs).
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: STUDY GROUP
they received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week.
The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
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progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week.
The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
|
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No Intervention: control group
received a designed physical therapy program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross motor functional measurement
Time Frame: pre and after 3 months of intervention,, the higer score will represent the improvement
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The GMFM is a standardized observational scale designed and validated to measure change in gross motor function over time in children with CP.
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pre and after 3 months of intervention,, the higer score will represent the improvement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isometric muscle strength measurements
Time Frame: pre and after 3 months of intervention,, increase in muscle will represent the improvement
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The gold standard for evaluating isometric muscle strength is the portable dynamometer.
This is an easy-to-use, sensitive device for detecting muscular action and for performing objective, valid, and reliable measurements in several populations
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pre and after 3 months of intervention,, increase in muscle will represent the improvement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 20, 2021
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
January 19, 2021
First Submitted That Met QC Criteria
January 20, 2021
First Posted (Actual)
January 26, 2021
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Hana 5
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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