| CTRI Number |
CTRI/2010/091/001414 [Registered on: 28/10/2010] |
| Last Modified On: |
08/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A randomized clinical trial to study the effect of Reflexology therapy along with conventional therapy in children with spastic cerebral palsy |
Scientific Title of Study
Modification(s)
|
Evaluation of Reflexology as an adjunctive therapy in children with spastic cerebral palsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr V Bharathi Maran |
| Designation |
PhD Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No: 3005, 3rd Floor, PC Block,
Dept of Biophysics, All India Institute of Medical Sciences
New Delhi
DELHI
110 029
India |
| Phone |
011-26593215 |
| Fax |
011-26588641 |
| Email |
vbmaran@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Krishna Dalal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room. No: 3005 - B, 3rd Floor, PC Block
Dept of Biophysics, All India Institute of Medical Sciences
New Delhi
DELHI
110 029
India |
| Phone |
011-26593215 |
| Fax |
011-26588641 |
| Email |
drkrishnadalal@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sheffali Gulati |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room. No: 3055, 3rd Floor, PC Block
Dept of Pediatrics, All India Institute of Medical Sciences
New Delhi
DELHI
110 029
India |
| Phone |
011-26594679 |
| Fax |
011-26588641 |
| Email |
sheffaligulati@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
Primary Sponsor
Modification(s)
|
| Name |
All India Institute of Medical Sciences |
| Address |
Dept of Biophysics, All India Institute of Medical Sciences |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Bharathi Maran |
Department of Biophysics, All India Institute of Medical Sciences, NEW DELHI |
Room No: 3005, 3rd Floor, PC Block,Dept of Biophysics, All India Institute of Medical Sciences-110 029
New Delhi
DELHI |
011-26593215
011-26588641
vbmaran@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences New Delhi ? 110 029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Spastic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy along with physiotherapy and occupational therapy |
Conventional therapy will be assigned by the concerned clinician |
| Intervention |
Reflexology therapy |
The intervention will be done by the Reflexology therapy which will be of 30 minutes duration twice a day, during which the specific reflex areas on feet will be stimulated along with the conventional therapy. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with a diagnosis of spastic cerebral palsy and mixed cerebral palsy.
2. Patients with spastic cerebral palsy with conventional medical treatments (on oral anti spasticity drugs + Physio and occupational therapy)
4. Patients who are residents of Delhi or have
arrangement for stay over Delhi / NCR for a minimum
duration of 10 weeks for training the caregivers
and monitoring the health conditions of the
subjects at each step of therapy session.
|
|
| ExclusionCriteria |
| Details |
1. Fixed contractures
2. Children with severe intractable epilepsy as co
morbidities
3. Children had received botox (last 1 yr) or has
undergone phenol block injection and intrathecal
baclofen medication
4. Care giver not willing to sign the informed consent
form.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Gross Motor Function Measure (GMFM)Score |
6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Modified Ashworth scale (MAS)- change in spasticity score at elbow flexors and wrist flexors in upper limb and knee flexors, plantar flexors and hip adductors in the lower limb from baseline to follow up data.
2. Range of Motion (ROM) measured by goniometry in lower limb at popliteal angle, ankle dorsiflexion angle and hip adduction angle from baseline to follow up data. |
6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="176"
Sample Size from India="176"
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
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/07/2010 |
| 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
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The proposed research project was a randomized clinical trial in determining the efficacy of reflexology therapy in addition to the ongoing conventional therapy in children with spastic cerebral palsy. Cerebral Palsy describes a group of disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception and/or by a seizure disorder. Spastic cerebral palsy is the most common form of Cerebral Palsy. The incidence is 2 to 2.5 per 1000 live births. It is estimated that there are 25, 00,000 persons with cerebral palsy in India. Cerebral palsy cannot be cured but by multi disciplinary management all the problems can be addressed. The goals of management should be to use appropriate combinations of interventions (e.g., developmental, physical, medical, surgical, chemical and technical modalities) to promote function, to prevent secondary impairments and to increase the childs developmental capabilities. In recent time there has been considerable interest in "complementary and alternative medicine (CAM) among the population in Asia, UK, USA and other parts of globe which has been combined with the conventional therapies treatment so that the individual patient can get maximum benefits. It has been observed that even the adequate pharmacological therapies and surgical procedure do not offer a complete management of spastic cerebral palsy. In view of this, the proposed study presents another mode of intervention in addition to the existing ones to observe the effect of reflexology therapy in the management of spastic cerebral palsy. This will be helpful in establishing reflexology as a low cost medical system with least side effect. This study is a Randomized, parallel group, active controlled trial comparing the efficacy of reflexology + conventional therapy in children with spastic cerebral palsy to the conventional therapy alone for a period of six months in 176 patients with spastic cerebral palsy that will be conducted at Dept of Biophysics, All India Institute of Medical Sciences, New Delhi. The primary outcome measure will be the change in Gross Motor Function Measure (GMFM) score at the end of six months from the date of patients enrollment for this study. The secondary outcome measure will be the change in spasticity in children with spastic cerebral palsy as measured by Modified Ashworth Scale (MAS) and to measure the Range of Motion (ROM) by Goniometry at the end of six months. |