| CTRI Number |
CTRI/2024/10/076013 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| 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
|
Effectiveness of PNF exercise on upper limb motor recovery in stroke |
|
Scientific Title of Study
|
Effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) Exercise on Upper limb Motor Recovery in Patients with Stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Saifur Rahman |
| Designation |
MPT-Neurology Student |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Physiotherapy and Rehabilitation Department, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
7408
Other |
| Phone |
01713958916 |
| Fax |
|
| Email |
saifur.nitor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant Professor and Chairman |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Physiotherapy and Rehabilitation Department, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
7408
Other |
| Phone |
01716062263 |
| Fax |
|
| Email |
ehsanurrahmanbhpi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kazi Md Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Physiotherapy and Rehabilitation Department, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
7408
Other |
| Phone |
01735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
(JUST), Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
MD Saifur Rahman |
| Address |
Physiotherapy and Rehabilitation Department, Jashore University of Science and Technology(JUST), Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [self-funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Koushik Ahmed |
Centre for the Rehabilitation of the Paralysed (CRP) |
Room no: 204, 1st floor, Neurology unit, CRP, Chapain, Savar, Dhaka-1343, Bangladesh
|
01975300577
ahmed.koushik@proton.me |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of the Department of Physiotherapy and Rehabilitation of Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Active assisted range of motion exercise for hand and wrist, prolong stretching exercise for spastic muscle, weight-bearing exercise for upper extremity, pegboard exercises, strengthening exercises for wrist and hand, reaching and grasping activities of hand and coordination exercises for 24 sessions |
| Intervention |
PNF Intervention + Conventional physiotherapy |
Patients will be given PNF exercises from the first day for 24 sessions of their admission to our study setting starting from trunk, scapula, and pelvis. PNF for neck: Flexion with rotation to the left and extension with rotation to the right and vice-versa, 10 repetitions of each pattern. PNF for trunk: Rhythmic stabilization and alternating isometrics, 10 repetitions. PNF for scapula and pelvis: Anterior elevation and posterior depression; posterior elevation and anterior depression by rhythmic initiation and repeated contraction. For upper extremity: D1 and D2 flexion and extension patterns for Upper extremity. Patients will be discharged with instructions to continue the exercises at home along with medication and it will be ensured over the phone. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be in the chronic phase of stroke (greater than 3 months post-stroke), including both ischemic and hemorrhagic types. Both males and females aged 40 to 70 years will be recruited. Eligible participants will have a Modified Ashworth Scale score between 1 and 3 and a Fugl-Meyer Upper Extremity Assessment score greater than 18. They must have the ability to sit independently, experience pain below 5 on the NPRS, and be able to follow simple commands. Participants will include individuals capable of adhering to instructions, with no significant cognitive impairment.
|
|
| ExclusionCriteria |
| Details |
We will exclude the participants if anyone having neurological disorders (Parkinson disease, Dementia), Shoulder hand syndrome, Recent fractures, Acute cardio-respiratory diseases/ severe cardiac illness, Hearing deficits, Severe cognitive impairment (MMSE greater than 19), Uncontrol blood pressure, Others systemic disease (RA, AS). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS, Fugl Meyer Assessment scale upper extremity, Action Research Arm Test (ARAT) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Ashworth scale, Nine Hole Peg test |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="0"
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)
|
08/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
This research aims to investigate the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) exercise in addition to conventional physiotherapy for improving upper limb function in individuals with stroke. Thirty participants aged 40-70 years will be randomly divided into a control and experimental group using purposive sampling. The experimental group will receive PNF exercise along with conventional physiotherapy, while the control group will receive only conventional physiotherapy. Participants will be assessed at baseline and after 6 weeks of intervention using the NPRS, Fugl-Meyer Assessment Scale, Action Research Arm Test (ARAT), Modified Ashworth Scale, and Nine-Hole Peg Test. These tools will evaluate motor function, spasticity, and fine motor coordination in both groups. This study will provide valuable insights into the potential benefits of PNF exercise in enhancing upper limb recovery after stroke |