| CTRI Number |
CTRI/2024/07/070557 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Chest muscle Stretch (Proprioceptive Neuromuscular Facilitation) Technique & Conventional Physiotherapy on Reaching performance in individuals with Stroke. |
|
Scientific Title of Study
|
Effect of Chest PNF Techniques Vs Conventional Physiotherapy on Reaching performance in individuals with Stroke: A Pilot |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayoni Shah |
| Designation |
PG student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Ground Floor
Neurophysiotherapy department
DES Brijlal Jindal College of Physiotherapy
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9820979063 |
| Fax |
|
| Email |
sayonirshah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshada Sonawane |
| Designation |
Associate Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Ground Floor
Neurophysiotherapy department
DES Brijlal Jindal College of Physiotherapy
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayoni Shah |
| Designation |
PG student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Ground Floor
Neurophysiotherapy department
DES Brijlal Jindal College of Physiotherapy
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9820979063 |
| Fax |
|
| Email |
sayonirshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.E.S. Brijlal Jindal College of Physiotherapy, Pune - 411004, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Sayoni Shah |
| Address |
B-1201, Shanti Kamal, Bhai Bal Mukund Marg, Dr.BA Road, Chinchpokli (E), Mumbai-400012 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Sayoni Shah |
DES Brijlal Jindal College of Physiotherapy |
Outpatient Department Gate no. 2 Fergusson College Shivajinagar
Pune
Pune
MAHARASHTRA |
9820979063
sayonirshah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D E Societys Brijlal Jindal College of Physiotherapy Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chest PNF (Proprioceptive Neuromuscular Facilitation) |
Repeated Stretch technique is used.
Intercostal and diaphragm Facilitation is given in supine, prone and side lying position.
3 set 10 repititions for 4 weeks 3 times a week |
| Comparator Agent |
Conventional Physiotherapy |
Upper limb ROM exercises, Stretching and voluntary control training
3 times a week for 4 weeks for a duration of 30 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Stroke patients with only one hemisphere involvement
2) Stroke onset from 2 weeks to 6 months
3) Chedoke-McMaster Stroke Assessment Score greater than 3 for the arm and hand
4) No cognitive impairment |
|
| ExclusionCriteria |
| Details |
1. Any orthopaedic, respiratory and neurological conditions affecting the diaphragm
2. Rib fracture
3. Recent thoracoabdominal surgeries
4. Any orthopaedic or neurological condition affecting the shoulder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reaching Performance Scale for Stroke |
Baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
25/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
in this study titled "Effect of Chest PNF Techniques Vs Conventional Physiotherapy on Reaching Performance in individuals with Stroke: A Pilot" participants with stroke in control and experimental group will be assessed using Reaching Performance Scale, pre and post intervention (baseline & at the end of 4 weeks). Participants in both control & Experimental group will receive upper limb exercises for to improve ROM, Stretching and voluntary control training 3 times a week for 4 weeks for 30 mins duration. In addition to this, Experimental group will receive repeated stretch technique of PNF to Intercostal muscles & diaphragm in supine, prone & side lying position; 3 sets of 10 repetitions 3 times a week for 4 weeks.
Post assessment at the end of 4 weeks, data will be analyzed using appropriate statistical tests and results will be discussed and then published.
|