Functional Electrical Stimulation With Core Stabilization Exercises in Children With Spastic Diplegia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University
About this trial
This study was done to:
* investigate the combined effect of functional electrical stimulation with core stabilization exercises on pelvic tilting in children with spastic diplegia. * To investigate the combined effect of functional electrical stimulation with core stabilization exercises on standing balance in children with spastic diplegia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Their age will range from 4 to 6 years.
Their degree of spasticity will range from 1 to 1+, according to the modified Ashworth scale.
Their motor function will be at level Ⅰ & Ⅱ according to gross motor function classification system.
Their pelvic tilting angle will be more than 7.6°
Disqualifiers
Musculoskeletal fixed deformities in lower limbs and spine
Visual or hearing problems
Epilepsy
Botulinum toxin injection or orthopedic surgery within past 6 months or within study period
Trial design
Design model
Parallel
Treatments tested in this trial
designed physical therapy program
Other interventiona one-hour physical therapy program, focusing on abdominal and back muscle activation and improving balance during standing. The program includes exercises like supine on wedges, prone on wedges, weight shifting, and balance training.
core stabilization exercise with neuromuscular electrical stimulation
Other interventionThe text describes various exercises for children to improve their physical abilities. These exercises include bridging, crab, plank, superhero, wheelbarrow walk, and kneeling on balls. The placement of electrodes on the gluteus maximus and rectus abdominis muscles is determined using anatomical landmarks. The electric current is generated using a biphasic symmetrical waveform with pulse width and intensity, and the stimulus frequency is adjusted to 35 Hz. The neuromuscular electric stimulation mode is used in a Synchronous mode.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: functional electrical stimulation and designed physiotherapy programExperimental treatment 2 interventions
Group B: designed physiotherapy programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of muscle tone
The modified Ashworth scale will be used to determine the degree of spasticity of the affected lower limb; the child will be in supine position with head in neutral position, and the examiner will moves the knee of affected side through full range of flexion and extensions the child is instructed to stay relaxed and to avoid resisting or facilitating the joint movement applied by the examiner; children with grades 1 or 1+ will be included
Time frame
at baseline and after 12 weeks2
Assessment of gross motor function level
The Gross Motor Function Classification System is a clinical classification system with five levels based on functional limitations, the need for handheld mobility devices, and movement quality. It includes children with level I and II and those transported in a manual wheelchair.
Time frame
at baseline and after 12 weeksSecondary outcomes
1
Assessment of change of pelvic tilting
Pelvic inclinometers and pelvic meter (PALM) are devices designed to assess pelvic tilt. Pelvic inclinometers have adjustable arms for direct contact with bony landmarks, while Pelvic inclinometers and pelvic meter have adjustable arms for contact with the anterior superior iliac spine and posterior superior iliac spine. These devices are typically used in a relaxed standing position, with children with a pelvic tilting angle over 7.6° included.
Time frame
at baseline and after 12 weeks2
Assessment of change of balance
The Humac Balance System is a combination of a balance board and Humac Balance software, providing a robust assessment tool for static and dynamic balance. It offers various training and measurement routines, including weight-bearing random motions, center of pressure, limits of stability, and roadway measurements.
Time frame
at baseline and after 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: