| CTRI Number |
CTRI/2024/04/066251 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy] |
| Study Design |
Other |
|
Public Title of Study
|
A proper physiotherapy protocol for the problems which develops in AIDP along its course particularly focusing on the pain, musculoskeletal issues and respiratory issues |
|
Scientific Title of Study
|
Effectiveness of goal directed physiotherapy protocol for symptom progression of pain, respiratory dysfunction and musculoskeletal dysfunction in acute inflammatory demeylinating polyneuropathy- A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Dey |
| Designation |
Junior resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research,Sawangi (Meghe), Wardha
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research,Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9145084005 |
| Fax |
|
| Email |
shivani190410@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghumahanti Raghuveer |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of higher education and reseaarch |
| Address |
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research,Sawangi (Meghe), Wardha
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research,Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghumahanti Raghuveer |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of higher education and reseaarch |
| Address |
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research,Sawangi (Meghe), Wardha
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research,Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ravi nair physiotherapy college, Acharya vinoba bhave rural hospitl, Datta meghe institute of higher education and research (deemed to be university), Sawangi Meghe, Wardha, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Ravi nair college of physiotherapy |
| Address |
Ravi nair college of physiotherapy, Datta meghe institute of higher eductaion and research, Sawangi(Meghe), Wardha, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivani Dey |
Acharya vinoba bhave rural hospital, Neurology ICU & Ward, Neuro Physiotherapy OPD |
Department of Neuro physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher eduactaion and research, Sawangi (Meghe), Wardha-442001,Maharashtra
Wardha
MAHARASHTRA |
9145084005
shivani190410@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G60-G65||Polyneuropathies and other disorders of the peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional physiotherapy protocol |
The total duration of the intervention will be of 5 weeks.During the acute phase and recovery phase, chest physical therapy including breathing exercises, postural drainage and manual chest percussion and vibrations will be provided. Passive range of motion thrice a day along with joint approximation will be given to increase mobility. To prevent pressure ulcers and bed sores, the position will be changed 2 hourly. For pain relief, TENS can be given initially.
During the recovery phase, Proprioceptive neuromuscular facilitation for increasing strength will be initiated along with strengthening using isometric and isotonic which can be later progressed to endurance training. The patient will also be taught task training. |
| Comparator Agent |
Goal oriented protocol for symptom progression |
The total duration will be of 5 weeks.During the acute and plateau phases, for the management of musculoskeletal impairments, the goal will be to restore the functional ability, which will be facilitated by rolling initiation, transition training and positioning. To restore mobility and strength, passive range of motion, PNF D1-2 pattern with rhythmic initiation and quick stretch, facilitatory techniques by Roods and MET along with splinting will be provided. For the management of cardiorespiratory impairments, to facilitate clearance of chest, postural drainage along with manual chest percussions and vibrations. To improve the aeration of lungs by active contraction of the diaphragm, diaphragmatic breathing exercise and diaphragmatic PNF focusing on repeated contraction and rhythmic stabilisation will be emphasized, if the patient is mechanically ventilated, initial stretch technique will be provided. For reducing fatigue with exercises, pursed lip breathing along with energy conservation technique will be taught. For the management of pain and any secondary impairments such as bed sores, TENS and IRR along with adequate positioning will be given.
During the recovery phase, to manage musculoskeletal impairments, the goal will be to provide functional independence by promoting more bed mobility and functional training. For the management of and mobility, the goal will be to normalize the strength and range of motion of the weak musculatures of the extremities by providing active, active assisted and resisted range of motion, PNF, NMES and MET. Pre gait training along with gait training will be initiated in parallel bar using postural mirror. For the management of cardiorespiratory impairments, to normalize the strength of diaphragm, resisted diaphragmatic breathing, Diaphragmatic PNF and inspiratory resistance training. To increase the endurance, graded non fatigable aerobic exercise protocol will be given.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1- Both male and female population
2- Adult aged more than 18 years
3- Patients who are just diagnosed with GBS and are falling into the acute phase of rehabilitation.
4- The patients should fulfill the standard diagnostic criteria for GBS as defined by the National Institute of Neurologic Disorders and Stroke clinical criteria. They will be categorized into AIDP further by electrodiagnostic testing.
5- Patients suffering from musculoskeletal and respiratory impairments and are/ not on ventilator
|
|
| ExclusionCriteria |
| Details |
1- Patient who is below 18 years of age
2- Patient who is deteriorating or are not vitally stable.
3- Patient who has any preexisting or existing condition like trauma, current infection, etc.
4- Chronic GBS cases, who are presently in their recovery stage.
5- Any other cardiovascular abnormalities along with the condition such as myocardial involvement and cardiac arrhythmias.
6- Any recent fracture, musculotendinous injury, and any joint pathologies.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- VAS (Visual Analog Scale) for pain
2- Modified Erasmus Outcome Score for GBS (mEGBS) for prognosis
3- Modified Erasmus Respiratory Insufficiency Score (megris) for mechanically ventilated patients in GBS for respiratory insufficiency
4- MMT (MRC Grading) for strength
5- SPO2 (Pulse oximeter) for oxygen saturation
|
Outcomes will be assessed at the baseline and after every week till the 5th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- FSS (Fatigue Severity Scale) for measuring the level of fatigue
2- Braden Scale (Pressure Sore Risk) for assessing the risk of pressure sores
|
Outcomes will be assessed at the baseline and after every week till the 5th week |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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)
|
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
|
The study will aim to evaluate a goal-directed physiotherapy protocol for symptom progression of pain, respiratory impairments, and musculoskeletal impairments in Acute inflammatory demyelinating polyneuropathy (AIDP) patients along their disease progression. It will be devised for a period of 5 weeks and intervention will be modified based on the symptoms.The purpose of this study is to compare the effectiveness of goal directed physiotherapy protocol over conventional physiotherapy protocol. |