| CTRI Number |
CTRI/2016/08/007150 [Registered on: 05/08/2016] Trial Registered Prospectively |
| Last Modified On: |
05/08/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the outcomes of home based and supervised individually designed exercise programme amongst the patients in chronic phase after Guillain Barre syndrome. |
|
Scientific Title of Study
|
A Study to compare the Outcomes of Home Based and Supervised Individually Designed Exercise Programme for Patients in Chronic Phase after Guillain Barre Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Shrivastava |
| Designation |
Proffessor and HOD Department of Transfusion Medicine |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Department of Transfusion Medicine, Bhopal Memorial Hospital and Research Center, Raisen bypass road, Bhopal,
Department of Transfusion Medicine, Bhopal Memorial Hospital and Research Center, Raisen bypass road, Bhopal.
Bhopal
MADHYA PRADESH
462038
India |
| Phone |
9425012342 |
| Fax |
7552748039 |
| Email |
manishasdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nehal Shah |
| Designation |
Department of Physiotherapy |
| Affiliation |
Bhopal Memorial Hospital and Research Center |
| Address |
Department of Physiotherapy, Bhopal Memorial Hospital and Research Center, Raisen bypass road, Bhopal,
Department of Transfusion Medicine, Bhopal Memorial Hospital and Research Center, Raisen bypass road, Bhopal,
Bhopal
MADHYA PRADESH
462038
India |
| Phone |
9424442993 |
| Fax |
7552748039 |
| Email |
nehalravirajshah@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nehal Shah |
| Designation |
Department of Physiotherapy |
| Affiliation |
Bhopal Memorial Hospital and Research Center |
| Address |
Department of Physiotherapy, Bhopal Memorial Hospital and Research Center, Raisen bypass road, Bhopal,
Department of Physiotherapy, Bhopal Memorial Hospital and Research Center, Raisen bypass road, Bhopal,
Bhopal
MADHYA PRADESH
462038
India |
| Phone |
9424442993 |
| Fax |
7552748039 |
| Email |
nehalravirajshah@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, Under Department of Health Research, Government of India |
|
|
Primary Sponsor
|
| Name |
Bhopal Memorial Hospital and Research Centre |
| Address |
Raisen Bypass road,
Bhopal, MP, India
462038 |
| 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 Manisha Shrivastava |
Bhopal Memorial Hospital and Research Centre |
Bhopal Memorial Hospital and Research Centre, Raisen bypass road, Bhopal
Bhopal
MADHYA PRADESH |
9425012342
7552748039
manishasdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Bhopal Memorial Hospital and Research Centre) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Guillain Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home Based Exercise programme |
The participants will receive home based exercise programme of maintenance exercises and education for self management exercise programme for about 30 minutes 2 to 3 times per week. The patients who will need more intensive physiotherapy treatment will be offered treatment.These patients will receive a two monthly telephone call/personal contact to get the information about activity levels and their medical visits. |
| Intervention |
Supervised individually designed exercise programme |
The supervised physiotherapy programme will include up to three one- hour interrupted physiotherapy session per week for strengthening, endurance, gait training and pain management for up to twelve weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age of “definite†GBS diagnosed through World Health Organization of International Classification of Disease, having current stable medical course within last five years and all new cases, confirmed by physician/neurologists.
We shall include only those participants who have a physical disability as assessed by the International Classification of Impairment, Disability and Handicap (WHO 1980) was updated by the World Health Organization to the International Classification of Functioning, Disability and Health (WHO 2001), as an international standard to describe health and disability
Clinical judgement of the assessing physician/ physiotherapist regarding potential benefits of the physiotherapy programme to the individual.
All variants of GBS will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patient those who have received the physiotherapy treatment in the period of previous 6 months.
|
|
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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 |
| Functional impairment measurement |
At the time of recruitment, at six months, at 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue Severity Scale,MRC manual muscle testing, Visual analog scale for pain, Barthel Index for activities of daily living, World Health Organization Quality of Life |
at the time of recruitment, at six months, at 12 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2016 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Patients of Guillain Barre syndrome managed with Therapeutic Plasma Exchange (TPE) and physiotherapy. Changes and disability, physical functioning and muscle strength. Nehal S, Manisha S, Seema N, JDMIMS, Vol 10. No 1. 2015.
Role of Physiotherapy in Guillain Barre syndrome: a Narrative Review. (International Journal of Health Science and Research). Nehal S, Manisha S. Int J Health Sci Res. 2015; 5(9):529-540.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Guillian Barre syndrome (GBS) is an immune mediated disorder of peripheral nervous system of acute or sub acute onset. It is most commonly characterized by combination of generalized weakness paresthesias of limbs, and areflexias with incidence rate of 1 to 2 per 100,000 population.The treatment of GBS aims to accelerate recovery, reduce complication in acute phase of illness and decrease the amount of long term neurological residual disability. The progression of the disease depends upon its severity at onset. It suddenly progress to severely disabling paralysis of the limbs with in few days of onset and the disease severity reaches it peaks in two to three weeks in about 50% and 80% of cases respectively. The disease starts its recovery after two – four weeks leaving almost 20% of the patients disabled even after the treatment especially in ambulation. At present there is a scarcity of information on the effectiveness of the physiotherapy intervention in GBS as there is only one Randomized Control Trial (RCT) and two Systemic Reviews(SR) on multi-disciplinary (MD) and the review did not identified any RCT, SR, Clinical Control Trial or on physiotherapy which is the integral part of the treatment. GBS is not the disease to be treated in one day. It requires a long term physiotherapy rehabilitation and require the designing of specialized programme and active patient participation. There is a strict need of RCT in this field so as to evaluate the need of physiotherapy in GBS, effect of exercises in improving the functional outcome and to develop the exercise protocols for the patients and to make them independent in their functional status and activities of daily living. Objectives: · To evaluate the functional independence of the patients with chronic phase after Guillain Barre Syndrome (pwGBS) after home based exercise programme as compared to supervised individually designed exercise programme . · To evaluate the outcomes of the pwGBS patients in terms of fatigue, muscle power, pain, activities of daily living (ADL) and quality of life (QoL) after home based exercise programme as compared to supervised individually designed exercise programme Hypothesis: “We hypothesize that the supervised individually designed exercise programme would perform better than home based exercise program in achieving the outcomes of interest.†|