| CTRI Number |
CTRI/2025/08/092401 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| 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
|
Using brain gym exercises to support balance, prevent falls, and improve brain function in Parkinsons disease |
|
Scientific Title of Study
|
Effect of brain gym exercise
on balance, risk of fall and cognitive function in patients with 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 |
Dr Anamika Singh |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9818746385 |
| Fax |
|
| Email |
singh.anamika.0610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meetu |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416403155 |
| Fax |
|
| Email |
meetunagpalpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika Singh |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9818746385 |
| Fax |
|
| Email |
singh.anamika.0610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy PGIMS Rohtak |
| Address |
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 Anamika Singh |
Pt BD Sharma, PGIMS Rohtak |
Room number 141, Out patient department of Department of Neurology, Pt BD Sharma, PGIMS 124001
Rohtak
HARYANA |
9818746385
singh.anamika.0610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Approved by Institutional Ethics Committee, Pt. B. D. Sharma PGIMS, 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 |
Brain gym exercises |
3 sessions/week for 4 weeks |
| Comparator Agent |
Conventional physiotherapy |
3 sessions/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Age between 40-75 years
2)Diagnosed as PD with clinical score up to 3 on Modified Hoehn and Yahr scale.
3)Both Males and Females.
|
|
| ExclusionCriteria |
| Details |
1)Inability to follow commands
2)Recent surgical intervention
3)PD associated dementia diagnosed by neurologist
4)Individuals with vision or auditory disorders
5)Pre-existing orthopedic and muscular impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
Fall Efficacy Scale–International (Hindi)
Montreal Cognitive Assessment (Hindi version) |
Baseline to 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/08/2025 |
| 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 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
|
Background Parkinsons disease is a progressive neurodegenerative disorder that affects motor and cognitive functions. Balance impairment and increased risk of falls are major concerns in Parkinsons disease patients. Brain Gym is a movement based program designed to improve brain function and body coordination. It is being explored as a complementary therapy in neurological conditions.
Objective To investigate the effect of Brain Gym exercises on balance risk of fall and cognitive function in patients with Parkinsons disease.
Study Design This is a randomized parallel group active controlled trial.
Study Setting The study will be conducted at the College of Physiotherapy Pt BD Sharma PGIMS Rohtak Haryana India.
Participants Thirty patients diagnosed with idiopathic Parkinsons disease will be recruited and randomly allocated into two equal groups.
Intervention Group A will receive conventional physiotherapy. Group B will receive conventional physiotherapy along with Brain Gym exercises. The intervention will be given for four weeks.
Outcome Measures Balance fall risk and cognitive function will be assessed using standard clinical assessment tools before and after the intervention.
Expected Outcome The study aims to determine whether Brain Gym exercises can offer additional benefits when combined with conventional physiotherapy in improving motor and cognitive outcomes in patients with Parkinsons disease. |