| CTRI Number |
CTRI/2024/08/071993 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Plaster of Paris casting and Botulinum Toxin A Injection in improving ankle muscle tightness in Children with Cerebral Palsy |
|
Scientific Title of Study
|
To compare the efficacy of Serial Casting and Botulinum Toxin A in Spastic Equinus in Children with Cerebral Palsy: A Randomized Controlled Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikram Pratihast |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Physical medicine and Rehabilitation, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Madhupuri, Uttar Pradesh
229405
India
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8376883977 |
| Fax |
|
| Email |
vpratihast2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Kumar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room22, Department of Physical medicine and Rehabilitation, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Madhupuri, Uttar Pradesh
229405
India
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
6288930133 |
| Fax |
|
| Email |
arvindkgmu25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room22, Department of Physical medicine and Rehabilitation, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Madhupuri, Uttar Pradesh
229405
India
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
6288930133 |
| Fax |
|
| Email |
arvindkgmu25@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raebareli, Uttar Pradesh |
| Address |
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 |
| Type of Sponsor |
Government 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 Vikram Pratihast |
AIIMS Raebareli |
Room NO. 22/28, Ground Floor, Department of Physical Medicine and Rehabilitation
Raebareli
Uttar Pradesh
Rae Bareli
UTTAR PRADESH |
8376883977
vpratihast2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Botulinum Toxin A + Standard rehabilitation program. |
Intervention Group - Injection Botulinum Toxin
Participants in Intervention Group will receive a single dose of Injection Botulinum Toxin A. It will be
administered in the Gastrocnemius muscle of the affected lower limb. Depending on the body weight,
3-6 units/ kg will be injected in the gastrocnemius muscle and 1-3 units/ kg will be injected in the
soleus muscle.
It will be administered by the surface landmark technique. The child will lie in prone position.
Gastrocnemius is a superficial muscle, and a needle depth of 0.5 to 0.8 cm is enough to reach the
muscle. The injection will be given at the point of maximum calf girth in the medial and lateral heads
of the Gastrocnemius muscle and Soleus muscle.
One time administration of Injection Botulinum Toxin A will be done and the child will be followed up till 12 weeks. |
| Comparator Agent |
Serial Plaster of Paris casts + Standard rehabilitation program |
Comparator Group - Serial Casting After initial assessment, participants in Comparator Group will be given a below knee Plaster of Paris (POP) cast. It will be applied to the patient with the patient lying in supine position. The knee will be held in 90 degrees of flexion, and POP cast will be applied by giving maximum possible correction in dorsiflexion of the affected foot. Cast will be removed after 7 days of application, and a new cast will be applied following the same guidelines for a maximum of 3 serial casts. The target of giving greater correction will be 20 degrees of range of motion in dorsiflexion during each successive cast application.
POP cast will be applied every week for 3 consecutive weeks and the child will be followed up till 12 weeks from the date of first cast application |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children with Cerebral Palsy with equinus gait
2)Age group 3-12 years
3)Child should be ambulatory
4)Child should have standing and trunk control
5)Grade II or III spasticity in plantar flexor muscles
6)Child enrolled under various Government Health Schemes like Ayushman Bharat |
|
| ExclusionCriteria |
| Details |
1)Children having spasticity in Hip Adductors
2)Grade I or I+ spasticity in affected plantar flexor muscles
3)Child with Ataxic Gait
4)Child with bleeding disorder
5)Presence of hip pathology/ bony deformities/ foot deformities/ uncontrolled seizures
6)Non ambulatory child
7)Refusal to take part in the study
8)Poor trunk control |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Passive Range of Motion (in degrees) of Ankle Dorsiflexion in Affected foot
2) Active Range of Motion (in degrees) of Ankle Dorsiflexion in Affected foot |
Baseline
4 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Gross Motor Function Classification System (GMFCS)
2) Modified Ashworth Scale (MAS)
3) Modified Tardieu Scale (MTS)
4) Floor to Heel Test (in millimeters) |
Baseline
4 weeks
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cerebral Palsy is a broad diagnosis which includes various disorders affecting the child’s ability to maintain posture and balance. Spasticity is defined as an increase in muscle tone which is velocity dependent. It occurs due to damage to the pyramidal system in motor cortex in brain. Conservative strategies like physical therapy, occupational therapy, orthotics, and casting have a major role in improving motor abilities. Casting acts as a tone inhibitor which has show improvements in passive and active ankle dorsiflexion range of motion; however, equinus may occur again .Gastrocnemius insufficiency is the main factor in causing equinus gait which hampers the ambulation of children . The tone inhibiting ankle foot orthosis have not revealed much changes in equinus gait correction . An understanding of the maturity of gait is important in further management of spastic equinus gait. Based on results of previous studies, botulinum toxin and casting are two treatment modalities which have shown favorable outcomes for improvement in reduction of spasticity in equinus foot. There is a need of further research in understanding the efficacy of botulinum toxin A and serial casting in spastic equinus gait. Rationale of the Study-There are no standard guidelines regarding treatment choice in spastic equinus. Due to lack of enough robust studies regarding efficacy of Injection Botulinum Toxin A and Serial Casting in improving equinus spasticity and increasing the ROM, there is a need of further research into these treatment modalities, and their appropriate usage. This study aims to compare the efficacy of Injection Botulinum Toxin A and Serial Casting in spastic equinus in children with CP. The findings of this study could aid in developing treatment recommendations when using these two modalities. Aim- To compare the efficacy of Serial Casting and Injection Botulinum Toxin A in spastic equinus in children with cerebral palsy Objectives Primary objective-To assess and compare the changes in Active and Passive Dorsiflexion, between Serial Casting and Injection Botulinum Toxin -A groups Secondary objective 1) To assess the change in level of Gross Motor Function Classification System (GMFCS) 2) To assess the change in spasticity, using Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS) 3) To assess the change in heel to floor height |