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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04723641
Other study ID # Hana 5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2021
Est. completion date April 30, 2021

Study information

Verified date April 2023
Source Badr University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria: 1. Age ranged from 7 to 10 years old. 2. The degree of spasticity ranged from grade 1 to 2 hypertonia according to Modified Ashwarth Scale (MAS) 3. Level II and III on GMFCS-ER 4. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
functional training exercises
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.

Locations

Country Name City State
Egypt Hanaa Cairo

Sponsors (1)

Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross motor functional measurement The GMFM is a standardized observational scale designed and validated to measure change in gross motor function over time in children with CP. pre and after 3 months of intervention,, the higer score will represent the improvement
Secondary Isometric muscle strength measurements 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 pre and after 3 months of intervention,, increase in muscle will represent the improvement
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