| CTRI Number |
CTRI/2023/08/055957 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of pelvic exercises on children with cerebral palsy |
|
Scientific Title of Study
|
Kinematics and Posture in Children With Spastic Diplegic Cerebral Palsy: Role Of Pelvis
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Room no. LG13, Physiotherapy department, SGT Hospital, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana
Room no L10, D block, Physiotherapy dept, SGT University, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9958995444 |
| Fax |
|
| Email |
aarti_fphy@sgtuniversity.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Siddhartha Sen |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no L8, D block, Physiotherapy dept, SGT University, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Room no LG13, OPD Block, Physiotherapy department, SGT Hospital, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9958995444 |
| Fax |
|
| Email |
siddhartha_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Room no LG13, Physiotherapy dept, SGT Hospital, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana
Room no L10, D block, Physiotherapy dept, SGT University, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9958995444 |
| Fax |
|
| Email |
aarti_fphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Room no L10, D block, Physiotherapy dept, SGT University, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 |
| 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 Aarti Gupta |
SGT Hospital |
OPD Block, Room no LG13, Physiotherapy department
Gurgaon
HARYANA |
9958995444
aarti_fphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee, Faculty of Physiotherapy, SGT University |
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 |
No treatment will be given to this group. They will continue doing exercises they were doing earlier. |
| Intervention |
Pelvic control Exercises |
These exercises will be done manually by physiotherapist for 45 minutes, 3 times a week and for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed spastic diplegic CP
2.Age group from 5 to 12 years
3.Motor function of level I or II on the Gross Motor Function Classification System (GMFCS)
4.Spasticity of 1 or 1+ on the Modified Ashworth Scale as measured through hip adductors, internal rotators, quadriceps, and calf muscles
|
|
| ExclusionCriteria |
| Details |
1.Botulinum neurotoxins injection
2.Lower-limb casting within 6 months
3.Previous musculoskeletal surgery
4.Any limb length discrepancy
5.Attention deficit
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| posture & gait |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| balance |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
01/08/2023 |
| 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="0"
Months="8"
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
|
Children with CP often lack pelvic movement, with increased resistance to movement throughout range. Pelvic movement may be limited by increased postural tone or muscle tone in specific muscles and/or abnormal reciprocal innervation, i.e., hypoextensible musculature may mechanically constrain movement and characteristically widespread co-contraction in abnormal synergies increase limb stiffness and resistance to movement (Campbell, 1990). In some children with CP the hamstring muscles are spastic, exerting a force of backward rotation (posterior tilt) on the pelvis (Myhr and von Wendt, 1990) which limits anterior tilt. Conversely, some children may have increased spasticity in the hip flexors, pulling the pelvis into anterior tilt, and restricting posterior tilt. Although children, parents and physiotherapists often subjectively note changes in motor performance, there has been little actual research to substantiate the role of pelvic movements.
The aim of this study was to detect if the pelvic control exercises would improve posture in children with CP. |