| CTRI Number |
CTRI/2025/07/091972 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| 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
|
Improving Thinking, Balance, and Reducing Fall Risk in People with Parkinson’s Disease Using CoDuSe and Square Stepping Exercises |
|
Scientific Title of Study
|
Effect of CoDuSe and square stepping exercise on cognition, balance and risk of fall in patients with Parkinson’s 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 |
Akanksha Mittal |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy , PGIMS, Pt. B. D. Sharma University of Health Sciences |
| Address |
Physiotherapy Department, E- Block, College of Physiotherapy,
PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8059134361 |
| Fax |
|
| Email |
akankshabhawni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy , PGIMS, Pt. B. D. Sharma University of Health Sciences |
| Address |
Physiotherapy Department, Faculty room , E- Block, College of Physiotherapy,
PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yaahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy , PGIMS, Pt. B. D. Sharma University of Health Sciences |
| Address |
Physiotherapy Department, Faculty room , E- Block, College of Physiotherapy,
PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yaahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
| Address |
College of Physiotherapy Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
| 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 Megha Gakhar |
Pt. B.D. Sharma, PGIMS, Rohtak |
Neurology OPD, Room 131, Ch. Ranbir Singh OPD and Neurology Department, Ward No: 32, Lala Shyamlal Super Speciality Block and Physiotherapy Department, E-Block, College of
Physiotherapy, Pt. B.D. Sharma, PGIMS
Rohtak
HARYANA |
9896232146
meghs80@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
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 |
CoDuSe Exercise |
CoDuSe exercises include Core stability, Dual task training and Sensorimotor training. These will be given for 60 mins thrice a week for 4 weeks. |
| Comparator Agent |
Square Stepping Exercise |
This exercise will be given for 4-5 repetitions for 45 mins thrice a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients diagnosed with idiopathic Parkinson’s disease.
2. Both male and female will be included.
3. On modified Hoehn and Yahr scale 2 and 2.5 and 3
4. Participants voluntarily agree to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Participants with ay other neurological disease.
2. Patients having depression or any significant behavioral disorder.
3. Patients with unstable medical or surgical conditions.
4. Patients not willing to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Baseline (day 0), post-intervention (week 4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fall Efficacy Scale International |
Baseline (day 0), post-intervention (week 4) |
| Mini Cog Scale |
Baseline (day 0), post-intervention (week 4) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/07/2025 |
| 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
|
Background:
Parkinson’s disease (PD) is a progressive neurodegenerative disorder marked by motor and non-motor impairments that significantly affect quality of life. Falls and cognitive decline are common and debilitating complications in PD. While individual exercise programs have shown benefits, there is limited research on integrated interventions targeting multiple domains.
Objective:
To evaluate the effects of a combined CoDuSe (Core, Dual-task, Sensory) and Square Stepping Exercise (SSE) program on cognition, balance, and risk of fall in patients with PD.
Methods:
A true experimental, pretest-posttest design was used with 40 patients diagnosed with idiopathic PD (Hoehn and Yahr stage 2–3). Participants were randomly allocated into two groups:
Intervention was conducted over 4 weeks, 3 sessions per week. Outcome measures included Berg Balance Scale (BBS), Mini-Cog Scale, and Fall Efficacy Scale-International (FES-I). Data analysis was performed using descriptive statistics and t-tests.
Results:
Results are to be analyzed post-intervention. It is hypothesized that the combined CoDuSe and SSE group will show statistically significant improvements in balance, cognition, and reduced fall risk compared to SSE alone.
Conclusion:
This study aims to provide evidence supporting a comprehensive, dual-modality exercise intervention to improve functional outcomes in PD patients. If effective, this integrated approach could be adopted in rehabilitation protocols to reduce fall risk and enhance cognitive and motor performance in PD. |