| CTRI Number |
CTRI/2019/01/017037 [Registered on: 10/01/2019] Trial Registered Prospectively |
| Last Modified On: |
09/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to find the effect of training program in improving lying to sitting function in stroke patients |
|
Scientific Title of Study
|
A Study to analyze the effectiveness of training protocol in improving lying to sitting function in hemiplegic patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saranya D |
| Designation |
MPT Neurosciences |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
no:197/148 raja street, padi, chennai-50
sri ramachandra medical center and hospital,
neuromedicine wards
sri ramachandra nagar, porur
Chennai
TAMIL NADU
600050
India |
| Phone |
7338703337 |
| Fax |
|
| Email |
saranyayadhav5195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrsARajarajeswari |
| Designation |
Associate Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
sri ramachandra nagar, porur
sri ramachandra medical center and hospital,
neuromedicine wards
sri ramachandra nagar, porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
araji21@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MrsARajarajeswari |
| Designation |
Associate Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
sri ramachandra nagar, porur
sri ramachandra medical center and hospital
neuromedicine wards
sri ramachandra nagar, porur
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
araji21@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self sponsored |
| Address |
Sri Ramachandra Institute of Higher Education and Research
sri ramachandra nagar , porur-116 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| saranya D |
sri ramachandra medical center and hospital. |
Neuro medicine wards
sri ramchandra medical center and hospital
porur-116
Kancheepuram
TAMIL NADU |
7338703337
saranyayadhav5195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| students ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional exercises for control group |
Pelvic bridging exercise
2. Exercise to hemiplegic arm & leg
3.Practicsing supine to sitting technique
|
| Intervention |
specific training protocol to improve lying to sitting |
1.Facilitating breathing – Moving the chest passively, assisting expiration, Facilitating diaphragmatic breathing
2. Flexion or rotation of the upper trunk:
Patient position:
Supine lying with leg extended, abducted.
Active rotation forwards on sound side (upper trunk) to inhibit spasticity in the limbs
Active assisted training on affected side while instructing patient to flex and rotate towards the sound side.
Components:
Assisting passive movement - Passive flexion / rotation of the thorax while patients head remains on the plinth / pillow.
Facilitating active movement - The patient holds the position of his trunk actively and his head is guided into the correct position. Giving rotational support to the flexion, rotation and side flexion of the trunk.
3. Retraining active protraction of the scapula with activation of the oblique abdominal muscles:
Holding the ribs down actively, when the sound arm is placed in a vertical position.
Holding the ribs actively, when the affected arm is held at 90 degree flexion of the shoulder
Lifting the elbows into the air towards ceiling.
4. Rolling to prone:
Rolling towards the hemiplegic side.
Typical pattern for rolling over, using extension of the sound side.
Facilitation rolling towards the affected side.
5. Rolling towards the sound side:
Inhibiting unwanted pattern when rolling over towards the sound side, using extension.
6. Flexion/ rotation of the lower trunk:
Facilitating rolling to the sound side, where patient hands are clasped together and therapist supports hemiplegic leg.
Hemiplegic leg is lowered slowly to the surface when patient returns to supine.
7. Activating the oblique abdominal muscle in crook lying:
Passive flexion / rotation of the lower trunk.
Patient’s leg is totally supported against the therapist body.
With one hand over patient’s sacrum, the therapist gently flexes the lower lumbar spine.
8. Bridging for regaining selective extension of the hip together with abdominal muscle activity:
Facilitating the normal position over the pelvis.
9. Facilitating active control of hemiplegic leg through its range of motion
10. Sitting up over the side of bed:
Training normal sequence of movement including rotation of the trunk - initially fully supported with less assistance and then with no support.
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|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ischemic and hemorrhagic stroke
Patients diagnosed with acute CVA with persistent neurological deficits
Patients who are comprehending.
|
|
| ExclusionCriteria |
| Details |
• A resolved transient ischemic attack (brief neurological symptoms that are judged to have completely resolved upon presentation )
• A definite clinical contraindication or indication for either the sitting up or lying flat head position .
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.improvement in lying to sitting function - motor assessment scale
2.trunk impairment scale |
after 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| motor assessment scale |
10 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/01/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
to be published |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
it is an experimental study involving two groups of patients where one group will receive conventional treatment and another group will receive specific training protocol to improve lying to sitting function in hemiplegic patients and the outcome is evaluated after 10 days |