| CTRI Number |
CTRI/2025/08/092135 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| 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
|
Study on How Otago Exercises Can Improve Walking, Balance, and Reduce Falls in People with Parkinson’s Disease |
|
Scientific Title of Study
|
Effect of Otago exercises on balance, fall risk and gait in patients with Idiopathic Parkinsons disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shagun |
| 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
Rohtak
HARYANA
124001
India
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9588338357 |
| Fax |
|
| Email |
shagunsandhu002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple Choudhary |
| Designation |
Associate 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
Rohtak
HARYANA
124001
India
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9416666445 |
| Fax |
|
| Email |
dimplephysio80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimple Choudhary |
| Designation |
Associate 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
Rohtak
HARYANA
124001
India
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9416666445 |
| Fax |
|
| Email |
dimplephysio80@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shagun |
| 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 Dimple Choudhary |
Pt. B. D. Sharma , PGIMS, Rohtak |
Ch. Ranbir Singh OPD,
Department of
Neurology, room no.
141, PGIMS,Rohtak
,HARYANA
Rohtak
HARYANA |
94166 66445
dimplephysio80@gmail.com |
|
|
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: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Experimental Group) Otago Exercise Program + Conventional Physiotherapy |
The Otago Exercise Program (OEP) will be administered along with conventional physiotherapy. OEP includes lower limb strengthening exercises (hip abductors, knee extensors/flexors, ankle dorsiflexors/plantarflexors) using ankle cuff weights and progressive balance training (tandem stance, one-leg stance, backward walking, sit-to-stand, stair walking). Sessions will be conducted 6 days a week for 6 weeks, 40 minutes per session, delivered through telerehabilitation or home-based mode. The intensity and difficulty of the exercises will be increased gradually based on individual performance. |
| Comparator Agent |
Group B (Control Group) Conventional Physiotherapy |
The control group will receive conventional physiotherapy consisting of stretching exercises (hamstrings, hip flexors, calves), postural correction (chin tucks, glute bridge), balance training (tandem walking, side leg raises, one-leg standing), and lower limb strengthening exercises (heel raises, hip abduction/adduction, bridging). Sessions will also be delivered 6 days a week for 6 weeks, 40 minutes per session, either at home or via tele-mode. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 45 to 65 years.
2) Subjects with sufficient cognitive ability having MoCA score greater than or equal to 26.
3) Hoehn and Yahr scale staging upto 3. |
|
| ExclusionCriteria |
| Details |
1) Orthopaedic conditions affecting postural stability.
2) Neurological disorder affecting postural stability.
3) Disability in visual, auditory sensations and vestibular organs. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Activities Specific Balance Confidence Scale, Mini-BESTest Scale ,10 Metre Walk Test, Ink Footprint Method |
Day 0 and Day 36 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
11/08/2025 |
| 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 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 (PD) is a progressive neurodegenerative disorder marked by bradykinesia, rigidity, tremors, and postural instability. These motor symptoms significantly impair balance, gait, and increase fall risk, particularly in the elderly population. The Otago Exercise Program (OEP), originally designed for fall prevention in older adults, incorporates progressive strength and balance training and has shown promising results in improving physical stability.
This study aims to evaluate the effectiveness of OEP in improving balance, reducing fall risk, and enhancing gait parameters in patients with idiopathic Parkinson’s disease. A total of 36 patients aged 45–65 years will be recruited and randomly divided into two groups. Group A will receive Otago exercises along with conventional physiotherapy, while Group B will receive conventional physiotherapy alone.
The intervention will be delivered over 6 weeks, and outcomes will be measured using the Activities-Specific Balance Confidence (ABC) Scale, Mini-BESTest Scale, 10-Meter Walk Test, and Ink Footprint Method. By targeting both dynamic and static balance components, this study intends to provide clinical evidence for the use of OEP in PD rehabilitation to improve functional independence and quality of life. |