| CTRI Number |
CTRI/2019/06/019666 [Registered on: 14/06/2019] Trial Registered Prospectively |
| Last Modified On: |
13/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physical modality of treatment] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Shockwave therapy versus placebo in the treatment of tight calf muscles in children with cerebral palsy |
|
Scientific Title of Study
|
Prospective double blind RCT comparing radial Extracorporeal Shockwave therapy (rESWT) vs placebo in treatment of calf spasticity in children with cerebral palsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raj Manohar Nishanth Gollamandala |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Paediatric Orthopaedics office,1106, Paul Brand building,
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9720002327 |
| Fax |
|
| Email |
nishanthgrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhay Gahukamble |
| Designation |
Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Paediatric Orthopaedics office,1106, Paul Brand building,
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9600272174 |
| Fax |
|
| Email |
abhayg@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhay Gahukamble |
| Designation |
Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Paediatric Orthopaedics office,1106, Paul Brand building,
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9600272174 |
| Fax |
|
| Email |
abhayg@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College, Vellore
Tamil Nadu
632004 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raj Manohar Nishanth Gollamandala |
Paediatric Orthopaedic Out patient Department |
Christian Medical College
Vellore
Vellore
TAMIL NADU |
9720002327
nishanthgrm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB), Christian Medical College , Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, (2) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (3) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
radial extracorporeal shock wave therapy |
rESWT 1500 shots, 5 Hz, 0.03mJ/mm3
2 sittings , on day 1 and day 4 |
| Comparator Agent |
sham ESWT |
sham ESWT |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children with CP under 7 years of age with calf spasticity, MAS of 2 or more |
|
| ExclusionCriteria |
| Details |
Previous surgery to calf
Botox injection to the calf
Inability to comply with followup
Bleeding disorders/blood dyscrasias/ seizure disorder
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Calibrated passive range of motion of the ankle |
Immediate procedure
6 weeks
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth Scale (MAS)
Parent reported satisfaction on likert scale
Serious adverse effects |
6 weeks and 3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cerebral palsy (CP) is
one of the leading causes of movement and posture disorders. Cerebral palsy is
characterised by spasticity, decreased selective motor control and progressive
joint contractures. Calf spasticity is one of the common clinical features
which results in ankle equinus and decreased range of ankle dorsiflexion, which
if untreated, subsequently results in equinus contracture. rESWT is a new
modality of treatment for spasticity, In this study we will be comparing the
efficacy of rESWT in improving the ROM at the ankle as well as decreasing calf
spasticity.
Children with
CP under the age of 7 will be screened in the Paediatric Orthopaedic
out-patient department (OPD) and will be randomised to an intervention group
and a control group, 45 in each group. The intervention group will receive
rESWT and the control group will receive sham rESWT. Both groups will receive a
standardised regime of Oral baclofen and physiotherapy. rEWST will be given in
2 sittings , 3 days apart. The children
will be followed up at 6 weeks and 3 months.
The primary
outcome measure which is improvement in ankle dorsiflexion range will be
measured by using standardised clinical photographs and improvement in
spasticity by Modified Ashworth Score. At final followup, patient / parent
satisfaction will be evaluated on a 5 point likert scale
|