NCT05609422

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

November 2, 2022

Last Update Submit

April 8, 2023

Conditions

Keywords

diplegiacerebral palsycore stabilitytrunk control

Outcome Measures

Primary Outcomes (2)

  • 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

  • 2D video-based gait assessment system

    2D video-based gait assessment system to measure lateral trunk sway at SLS from frontal view

    3 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Received the designed physical therapy program.

Other: Physical therapy program

study group

EXPERIMENTAL

Received a designed physical therapy program in addition to scooter bord activities.

Other: Physical therapy programOther: scooter board activities

Interventions

* Stretching exercises * Strength Training Kneeling exercises * Standing exercises * Gait Training

control groupstudy group

1. Scooter board bear walk. 2. Scooter board crab walk. 3. Sitting on scooter board, use it to move forward and backward, move the pool rings from one end to another. 4. Cross sitting on scooter board, pulls along the rope using his/her hands 5. Sit with knees pulled into the chest (like a bug pose) and move around with arms only. 6. Prone over scooter board, pulling rope to move forward. Pull self along an anchored rope to retrieve items 7. 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. 8. Kneeling, Push self forward and backward with the use of a therapy ball (lots of Motor Planning). 9. Supine flexion on scooter board, Clip clothespins to a rope hanging above.

study group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • CP with a diplegia
  • Age 7 to 11 years
  • Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
  • They could walk with limitation or holding on according to GMFCS (level I\&II \&III) (Palisano et al., 1997).
  • They were able to understand and follow verbal instructions

You may not qualify if:

  • Children with any surgical interference in the upper limb.
  • intellectual disability such that simple tasks could not be understood or executed.
  • Children with any visual or auditory problems.
  • Children with any surgical interference in the lower limb.
  • Children with any structural deformities in joints and bones of lower limbs.
  • Children who suffer from other diseases or associated disorders that interfered with physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University

Badr, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Omnya samy, PHD

    lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The selected subjects will be divided into two groups of equal numbers (control and study).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Physical Therapy for Pediatrics and Pediatric Surgery, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

November 11, 2022

Primary Completion

March 12, 2023

Study Completion

April 8, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Private data for this research

Locations