| CTRI Number |
CTRI/2024/09/073341 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| 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
|
Improving Outcomes in Acute Guillain-Barre Syndrome: A Comparative Study of Proprioceptive Neuromuscular Facilitation versus Conventional Therapy, Assessing Pain, Fatigue, Symptom Severity, Functioning, and Respiratory Health. |
|
Scientific Title of Study
|
Effectiveness of Proprioceptive Neuromuscular Facilitation on pain, fatigue, severity, functionality and respiratory function in patients with acute Guillain-Barre Syndrome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Latasha |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9728590627 |
| Fax |
|
| Email |
dr.latashaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Latasha |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9728590627 |
| Fax |
|
| Email |
dr.latashaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India |
| Type of Sponsor |
Government 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 Latasha |
Pt. B. D. Sharma, PGIMS, UHS, Rohtak |
Ward 32 (Department of Neurology, Second floor, Lala Shyam Lal Super Speciality building) and Ward- 2203,2209,2210 (Department of Medicine) PGIMS, Rohtak, Haryana 124001
Rohtak
HARYANA |
9728590627
dr.latashaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/ UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercises |
Diaphragmatic breathing exercises for 15 min, 3 repetitions, 3 sets, and 7 days in a week.
Outline for Neck, Trunk, Upper and Lower Extremity: Passive Range Of Motion (ROM) → Active assisted ROM → Active ROM → Progressive resistance exercises (PREs) 1 set of 10 repetitions for each exercise performed 7 days in a week (BD). |
| Intervention |
Proprioceptive Neuromuscular Facilitation (PNF) |
PNF techniques (repeated stabilization, rhythmic contractions) to diaphragm for 15min, 3 repetitions, 3 sets, and 7 days in a week (BD).
PNF patterns D1,D2 (flexion and extension); PNF techniques (Alternating isometrics, Rhythmic stabilization, Rhythmic initiation, Slow reversals) to Neck, Trunk, Scapula and Pelvis, Upper and Lower Extremity for total 30 min, 10 reps each, 5days in a week (BD). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed clinically and electro-physiologically with GBS.
Age group above 18 years.
Both male and female gender.
Haemodynamically stable patients. |
|
| ExclusionCriteria |
| Details |
Unconscious patients.
Patients with Multi-organ failure.
Participants with history of amputation of limb(s).
Joint instability, recent fracture, or recent surgery.
Presence of psychiatric illness.
Communication challenges. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Severity with Hughes Functional Grading
Functionality with The Barthel Index |
Baseline (on admission)
At week 2
At discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain intensity with Numeric Pain Rating Scale |
Baseline (on admission)
At week 2
At discharge |
| Fatigue with Fatigue Severity Scale |
Baseline (on admission)
At week 2
At discharge |
| Respiratory Function with Single Breath Counting |
Baseline (on admission)
At week 2
At discharge |
|
|
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)
|
16/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
The study aims to assess the efficacy of Proprioceptive Neuromuscular Facilitation (PNF) compared to conventional exercises in addressing pain, fatigue, severity, functionality, and respiratory function in patients with acute Guillain-Barré Syndrome (GBS). Thirty eligible participants will be divided into two groups: Group A receiving PNF and Group B undergoing conventional exercises. Baseline and follow-up assessments using standardized scales will be conducted, and data will be analyzed using appropriate statistical methods to determine the intervention’s effectiveness. |