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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05609422
Other study ID # Omnya 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2022
Est. completion date April 8, 2023

Study information

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

Clinical Trial Summary

Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control. These changes, individually or collectively, affect psychomotor function. As a result, activities that are performed quickly and readily by healthy children may be difficult and time-consuming for children with CP.


Description:

Similar vestibular stimulation can be provided with ascooter-board which requires more active participation on the part of the child. A scooter-board is simply a wooden board mounted on four castors so that it can roll freely and spin in any direction, it should be big enough to support the middle part of the body while the head, upper chest and legs hang off the ends.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 8, 2023
Est. primary completion date March 12, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria: 1. CP with a diplegia 2. Age 7 to 11 years 3. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987). 4. They could walk with limitation or holding on according to GMFCS (level I&II &III) (Palisano et al., 1997). 5. They were able to understand and follow verbal instructions Exclusion Criteria: 1. Children with any surgical interference in the upper limb. 2. intellectual disability such that simple tasks could not be understood or executed. 3. Children with any visual or auditory problems. 4. Children with any surgical interference in the lower limb. 5. Children with any structural deformities in joints and bones of lower limbs. 6. Children who suffer from other diseases or associated disorders that interfered with physical activity.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical therapy program
Stretching exercises Strength Training Kneeling exercises Standing exercises Gait Training
scooter board activities
Scooter board bear walk. Scooter board crab walk. Sitting on scooter board, use it to move forward and backward, move the pool rings from one end to another. Cross sitting on scooter board, pulls along the rope using his/her hands Sit with knees pulled into the chest (like a bug pose) and move around with arms only. Prone over scooter board, pulling rope to move forward. Pull self along an anchored rope to retrieve items Scooter rolls outs. Place knees on floor and hands holding the edge of the front scooter board. Push board out a few inches then pull back, the further you roll, the harder it gets. Kneeling, Push self forward and backward with the use of a therapy ball (lots of Motor Planning). Supine flexion on scooter board, Clip clothespins to a rope hanging above.

Locations

Country Name City State
Egypt Badr University Badr Cairo

Sponsors (1)

Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk control measurement scale (TCMS) TCMS measures trunk control in two basic components:
static and dynamic sitting balance. Balance is assessed during flexion, extension, lateral flexion, and rotation movements as selective movements of dynamic sitting. Total score ranges between 0 and 58, and higher scores indicate better control
3 months
Primary 2D video-based gait assessment system 2D video-based gait assessment system to measure lateral trunk sway at SLS from frontal view 3 months
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