Use of Shockwave therapy versus placebo in the treatment of tight calf muscles in children with cerebral palsy

Phase 3

Not yet recruiting

Conditions: Spastic quadriplegic cerebral palsy, (2) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (3) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy,

Brief Summary: Cerebral palsy (CP) isone of the leading causes of movement and posture disorders. Cerebral palsy ischaracterised by spasticity, decreased selective motor control and progressivejoint contractures. Calf spasticity is one of the common clinical featureswhich results in ankle equinus and decreased range of ankle dorsiflexion, whichif untreated, subsequently results in equinus contracture. rESWT is a newmodality of treatment for spasticity, In this study we will be comparing theefficacy of rESWT in improving the ROM at the ankle as well as decreasing calfspasticity.

Children withCP under the age of 7 will be screened in the Paediatric Orthopaedicout-patient department (OPD) and will be randomised to an intervention groupand a control group, 45 in each group. The intervention group will receiverESWT and the control group will receive sham rESWT. Both groups will receive astandardised regime of Oral baclofen and physiotherapy. rEWST will be given in2 sittings , 3 days apart. The childrenwill be followed up at 6 weeks and 3 months.

The primaryoutcome measure which is improvement in ankle dorsiflexion range will bemeasured by using standardised clinical photographs and improvement inspasticity by Modified Ashworth Score. At final followup, patient / parentsatisfaction will be evaluated on a 5 point likert scale

Recruitment & Eligibility

Inclusion Criteria

Children with CP under 7 years of age with calf spasticity, MAS of 2 or more.

Exclusion Criteria

Previous surgery to calf Botox injection to the calf Inability to comply with followup Bleeding disorders/blood dyscrasias/ seizure disorder.

Primary Outcome Measures

Name	Time	Method
Calibrated passive range of motion of the ankle	Immediate procedure \| 6 weeks \| 3 months

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale (MAS)	Parent reported satisfaction on likert scale

Locations (1): Paediatric Orthopaedic Out patient Department
🇮🇳
Vellore, TAMIL NADU, India
Paediatric Orthopaedic Out patient Department
🇮🇳Vellore, TAMIL NADU, India
Dr Raj Manohar Nishanth Gollamandala
Principal investigator
9720002327
nishanthgrm@gmail.com