| CTRI Number |
CTRI/2019/09/021142 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
06/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two treatment strategies on lung function , hand
strengthening exercise with elastic band and normal physiotherapy in children with cerebral
palsy spastic diplegia of age group 6 to 10 years. |
|
Scientific Title of Study
|
Effect of upper extremity strengthening exercise with resistance band as an adjunct to conventional physiotherapy on respiratory function in children with cerebral palsy spastic diplegia aged 6 to 10 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika Sanjay Bombatkar |
| Designation |
Post Graduate student |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation Mumbai |
| Address |
All India Institute of Physical Medicine and Rehabilitaton
Department of Physiotherapy
K K Marg, Mahalaxmi
Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8857984139 |
| Fax |
|
| Email |
rasikabombatkar10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Wasnik |
| Designation |
Lecturer |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation Mumbai |
| Address |
All India institute of physical Medicine and Rehabilitaton
Department of Physiotherapy
K K Marg, Mahalaxmi
Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Wasnik |
| Designation |
Lecturer |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation Mumbai |
| Address |
All India institute of physical Medicine and Rehabilitaton
Department of Physiotherapy
K K Marg, Mahalaxmi
Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
All india institiute of physical medicine and rehabilitation, Mumbai 400034 |
|
|
Primary Sponsor
|
| Name |
Rasika Bombatkar |
| Address |
All india institiute of physical medicine and rehabilitation, Mumbai 400034 |
| Type of Sponsor |
Other [Principal Investigator Initiated] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sandya Wasnik |
All india institiute of physical medicine and rehabilitation, Mumbai 400034 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sandhya Wasnik |
All India institute of Physical Medicine and Rehabilitation, Mumbai 400034 |
Department of Physiotherapy Mumbai
Maharashtra
Mumbai
MAHARASHTRA |
9619144265
sandhyaw5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE AIIPMR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Conventional Physiotherapy, thrice in a week for four weeks. |
| Intervention |
Experimental Group |
Upper Extremity Strengthening Exercise with Theraband , thrice in a week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Cerebral palsy Spastic diplegia children in the age group 6 to 10 years
2. GMFCS Level II and III
3. Children who can understand and follow simple commands.
|
|
| ExclusionCriteria |
| Details |
1. Children with mental retardation
2. Children with visual and auditory impairments
3. Other types of CP i.e. ataxic, athetoid, hypotonic, dystonic CP 4. Children with neuromusculoskeletal disorders other than spastic diplegia CP.
5. Children with Uncontrolled epilepsy.
6. Any fixed Contracture and deformity of spine
7. Any selective dorsal rizotomy surgery .
8. Any respiratory illness in last 6 weeks.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary function test
Forced vital capacity (FVC)
Forced expiratory volume at one second (FEV1)
Peak expiratory flow (PEF)
FEV1/FVC ratio
|
At 0 week and after 4 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/09/2019 |
| 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="1"
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
|
This is an Interventional study comparing the effect of upper extremity strengthening exercise with theraband and conventional physiotherapy on respiratory function in children with Cerebral palsy spastic Diplegia aged 6 to 10 years.Total 40 subjects will be recruited for the study. Control and interventional group will have 20 subjects each. Each subject will receive exercise for 45-60 minutes per session, 3 days per week for 4 weeks ie total 12 sessions.Pre and post assessment of outcome measures will be done.Data will be statistically analysed . |