| CTRI Number |
CTRI/2023/12/060902 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Lee Silverman Voice Therapy BIG in patients with Parkinsons disease |
|
Scientific Title of Study
|
Effect of Lee Silverman Voice Therapy BIG (LSVT) on motor and non-motor symptoms in patients with Parkinsons disease |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8053624547 |
| Fax |
|
| Email |
abo9291998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anjana |
| Designation |
PG student |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8053624547 |
| Fax |
|
| Email |
abo9291998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Anjana |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Type of Sponsor |
Other [Self] |
|
|
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 Surekha Dabla |
Pt. B. D. Sharma , PGIMS, Rohtak |
Ch. Ranbir Singh OPD, Department of Neurology, room no. 141, PGIMS, Rohtak
Rohtak
HARYANA |
9518278066
surekhadabla@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group 1- LSVT BIG group |
task 1: two maximum sustain movements in a seated position in a chair - a) floor to ceiling , b) side to side exercise
task 2: five repeated directional movements in standing- a)three steps and reach exercises including forward reach and back, sideway reach to side and backward reach down and back, b) two rock and reach exercises, c)the sideway reach and twist, d) forwards/backward reach up and back, e)forward/ backward reach up and back
total 10 repetition for each task bilaterally |
| Comparator Agent |
group 2 - conventional exercise protocol |
1. trunk side flexion for 4 minutes
2. trunk rotation for 2 minutes
3. finger tapping for 2 minutes
4. marching in place with arm swings for 2 minutes
5. seated arm swing for 4 minutes
6. finger to nose for 2 minutes
7. stretching exercise for 10 minutes
8. theraband arm swing for 4 minutes |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 All the patients will be clinically diagnosed with parkinsons disease by a neurologist.
2 Patient on a stable dose of anti parkinsons medication.
3 Both male and female will be included in the study.
4 Patients having parkinsons disease for more than 6 months.
5 Participants voluntarily agree to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. participants associated with other neurological disease.
2. patients having severe depression or other significant behavioral disorders.
3. patients with unstable medical or surgical conditions.
4. participants who are not willing to participate. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Movement disorder sciety unified Parkinsons disease rating scale (MDS-UPDRS)
2. Back aniety inventor (BAI) |
Day 0, day 15 and day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
05/01/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Parkinson’s disease is a neurodegenerative disorder with motor and non motor symptoms affecting the quality of life. One of the recent advances in physiotherapy, to treat Parkinson’s disease patients, is LSVT BIG is one of the rehabilitation techniques that approach to trains large amplitude whole body movement to increase both the speed and amplitude of functional tasks in a patient’s with Parkinson’s disease. LSVT BIG therapy has been shown effective on the motor system and it is cnceptionally based on improving bradykinesia in particular the decrement of repetitive movement by proprioceptive recalibration. |