Clinical trial NCT06460714: Effects of Shockwave Therapy on Crouched Gait Due to Hamstring Flexibility in Cerebral Palsy Children
Official title: Effects of Shockwave Therapy on Crouched Gait and Hamstring Flexibility in Children With Diplegic Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Shock wave
Hamstring flexibility
Crouched gait
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control trial in which non-probability convenient sampling will be used. Both group of spastic CP of age 6 to 12 will be randomly divided. Group A will receive shockwave, stretching and orthosis. Group B will receive stretching and orthosis.
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.

Detailed description: Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days, five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.

In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.

Eligibility criteria: Inclusion Criteria:

* Children with GMFCS level I, II \& III.
* Passive range of motion of knee extension is limited to 20 degree with hip 90 degree.
* Age between 6 to 12 years.

Exclusion Criteria:

* Children with epileptic history
* Previous muscular lengthening technique applied
* Previous history of botox injection used.

Primary outcomes:
measure: Modified Ashwarth Scale
timeFrame: 8 weeks
measure: GMFM-88
timeFrame: 8 weeks
measure: Goniometer
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Punjab Special School
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Fahad Asif, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
citation: Lowing K, Arredondo YC, Tedroff M, Tedroff K. Introduction of the gross motor function classification system in Venezuela--a model for knowledge dissemination. BMC Pediatr. 2015 Sep 4;15:111. doi: 10.1186/s12887-015-0433-5.
citation: Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.