| CTRI Number |
CTRI/2026/02/105025 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Task-Oriented Training With and Without Proprioceptive Neuromuscular Facilitation on Arm Function in People With chronic Stroke |
|
Scientific Title of Study
|
Effects of task oriented training with or without propioceptive neuromuscular facilitaion replication technique on upper extremity motor function in chronic ischemic stroke subjects: a randomized clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Agrareema Sharma PT |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Department of Physiotherapy,Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),4-Vishnu Digamber Marg,New Delhi,India ,110002
New Delhi DELHI 110002 India |
| Phone |
7352924869 |
| Fax |
|
| Email |
agrareemasharma2201@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manju Vats Phd |
| Designation |
Lecturer PT |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Department of Physiotherapy,Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),4-Vishnu Digamber Marg,New Delhi,India ,110002
New Delhi DELHI 110002 India |
| Phone |
9891182228 |
| Fax |
|
| Email |
manju.vats@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manju Vats Phd |
| Designation |
Lecturer PT |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Department of Physiotherapy,Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),4-Vishnu Digamber Marg,New Delhi,India ,110002
New Delhi DELHI 110002 India |
| Phone |
9891182228 |
| Fax |
|
| Email |
manju.vats@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),4 Vishnu Digamber Marg,New Delhi |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [Rehabilitation Instituute ] |
|
|
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 Manju Vats |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
Department of Physiotherapy ,Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan),4-Vishnu Digamber Marg ,New Delhi,110002 New Delhi DELHI |
9891182228
manju.vats@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PDUNIPPD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries, (2) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Task Oriented Training and Conventional Physiotherapy |
The control group will receive task-oriented training and conventional physiotherapy only, without PNF replication.Group will undergo intervention sessions of 45–60 minutes duration, 3–5 days per week, for 4 weeks, totaling 20 sessions. |
| Intervention |
Task Oriented Training and Proprioceptive Neuromuscular facilitation replication Technique and conventional physiotherapy |
The experimental group will receive task-oriented training combined with upper extremity Proprioceptive Neuromuscular Facilitation (PNF) replication technique along with conventional physiotherapy. Functional upper-limb tasks such as reaching, hand-to-mouth activity, and supination–pronation will be performed using PNF replication to facilitate motor control and functional recovery. Group will undergo intervention sessions of 45–60 minutes duration, 3–5 days per week, for 4 weeks, totaling 20 sessions. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Unilateral Chronic Ischemic Stroke, with middle cerebral artery involvement confirmed with MRI or CT scan.
2.Both genders, having age range between 40-65 years.
3.Subject with Brunnstrom Voluntary Motor Control of Upper extremity more than or equal to 3.
4.Subjects with good trunk control and able to sit independently.
5.Subjects with Mini Mental State Examination (MMSE) score more than or equal to 24.
|
|
| ExclusionCriteria |
| Details |
1.Subjects other than cerebral stroke e.g Cerebellar, pontine or brain stem stroke.
2.Subjects with hemorrhagic or recurrent stroke.
3.Subjects with other brain disorders like subarachnoid hemorrhage, encephalitis, epilepsy, transient ischemic attack (TIA), or brain injury.
4.Subjects with heart failure symptoms, uncontrolled hypertension, or unstable angina.
5.Subjects having cognitive dysfunction, psychiatric disorder or not able to follow commands.
6.Subjects with musculoskeletal dysfunction in upper extremity like fracture, tendon, or muscle injury.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl Meyer Assessment of upper extremity (FMA-UE). |
Measurements will be taken at two time points: at baseline and after completion of 20 intervention sessions.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Functional Reach Test (MFRT) |
Measurements will be taken at two time points: at baseline and after completion of 20 intervention sessions.
|
| Box and Block Test (BBT) |
Measurements will be taken at two time points: at baseline and after completion of 20 intervention sessions.
|
| Motricity Index (MI) |
Measurements will be taken at two time points: at baseline and after completion of 20 intervention sessions.
|
|
|
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)
|
09/03/2026 |
| 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
|
Stroke is a leading cause of long-term disability, with chronic ischemic stroke survivors frequently experiencing persistent upper extremity motor impairments that limit functional independence and quality of life. This study is a randomized clinical trial designed to evaluate the effectiveness of task-oriented training with and without Proprioceptive Neuromuscular Facilitation (PNF) replication technique on upper extremity motor function in individuals with chronic ischemic stroke. Stroke survivors often experience long-term upper limb motor impairments that limit functional independence and quality of life, making effective rehabilitation strategies essential. A total of 40 participants with chronic unilateral ischemic stroke will be recruited and randomly allocated into two groups. The experimental group will receive task-oriented training combined with upper extremity PNF replication technique, while the control group will receive task-oriented training and conventional physiotherapy alone. Both groups will undergo intervention sessions lasting 45–60 minutes, 3–5 days per week, for a total duration of 4 weeks (20 sessions). Outcome measures used to assess upper limb motor function include the Modified Functional Reach Test (MFRT), Box and Block Test (BBT), Fugl-Meyer Assessment for Upper Extremity (FMA-UE), and Motricity Index (MI). Assessments will be conducted at baseline and after completion of 20 intervention sessions. The study aims to determine whether the addition of PNF replication technique to task-oriented training provides superior improvements in upper extremity motor function compared to task-oriented training alone. The findings are expected to contribute evidence for integrating PNF replication techniques into rehabilitation protocols for chronic ischemic stroke survivors. |