Clinical trial NCT06190418: Loaded Vs Unloaded Sit to Stand Strengthening Exercises in Children With Cerebral Palsy
Official title: Comparative Effects of Loaded and Unloaded Sit to Stand Strengthening Exercises on Functional Strength and Energy Expenditure in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy,
Energy Expenditure,
Muscle Strength
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. The most common cause of spastic diplegia is Periventricular leukomalacia, more commonly known as neonatal asphyxia or infant hypoxia-a sudden in-womb shortage of oxygen-delivery through the umbilical cord. Strength exercise is any activity that makes your muscles work harder than usual.

The significance of this study is that it will define whether loaded or unloaded sit to stand strengthening exercises have good effect on muscle strength and energy expenditure in diaplegic CP. This will be a randomized clinical trial, data will be collected from District Head Quarter DHQ hafizabad. Study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to stand up from chair independently and maintain standing for more than 5 seconds without falling will be included.Diplegic CP children who had not received any strengthening exercise program in past 3 months and those less than 20 degrees limitation in passive range of motion in hip flexion will be included. Those diplegic spastic CP who have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past six months and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded. Group A will be provided with loaded sit to stand strengthening exercises. 1 repetition maximum(1-RM) will be used as loaded sit to stand test. Group B will be provided with unloaded sit to stand strengthening exercises. Pre and post session lower limb functional strength will be measured by performing functional strength tests while lower limb muscular strength will be measured via modified sphygmomanometer and physiological cost index will be measured to rule out energy expenditure.


Eligibility criteria: Inclusion Criteria:

* Spastic diplegic cerebral palsy
* Age between 6 to 12 years
* Children with GMFCS level I and II
* Able to stand up from chair independently and maintain standing for more than 5 second without falling.
* Had not received any strengthening exercise program in past 3 months
* Parental commitment to allow participation without altering current activity

Exclusion Criteria:

* Participants with epileptic history and lower limb contractures are excluded
* Those who are unable to follow verbal command
* Have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past 6 months
* Orthopedic condition or medical problems that prevent children from participating in exercise

Primary outcomes:
measure: Muscle Strength
timeFrame: Baseline and 6th week
measure: Energy Expenditure
timeFrame: Baseline and 6th week
Secondary outcomes:
measure: Functional Strenght -Lateral Step-up Test (on a 20 cm bench)
timeFrame: Baseline and 6th week
measure: Functional Strenght -Sit-to-Stand (from 90 flexion of the knee and hip to standing position)
timeFrame: Baseline and 6th week
Other outcomes:
Locations:
city: Hafizabad
country: Pakistan
facility: District Headquarter Hospital,
Study officials:
affiliation: Riphah International University
name: Wasifa Rauf, MSPT(Peads)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kusumoto Y, Nitta O, Takaki K. Impact of loaded sit-to-stand exercises at different speeds on the physiological cost of walking in children with spastic diplegia: A single-blind randomized clinical trial. Res Dev Disabil. 2016 Oct;57:85-91. doi: 10.1016/j.ridd.2016.06.006. Epub 2016 Jul 7.
citation: Lee J, Suk MH, Yoo S, Kwon JY. Physical Activity Energy Expenditure Predicts Quality of Life in Ambulatory School-Age Children with Cerebral Palsy. J Clin Med. 2022 Jun 11;11(12):3362. doi: 10.3390/jcm11123362.
citation: Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.