| CTRI Number |
CTRI/2026/01/101112 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Physiotherapy (Not Including YOGA)
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of multicomponent rehabilitation on fall risk reduction in elderly patient hospitalized with parkinsonism and peripheral neuropathy |
|
Scientific Title of Study
|
Effect of multicomponent rehabilitation on fall risk reduction in elderly participant hospitalized with parkinsonism and peripheral neuropathy |
| 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 ABHISHEK B SANNATANGIYAVAR |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
| Address |
GERIATRIC MEDICINE, 5TH FLOOR- F BLOCK, EMD BUILDING, YENEPOYA MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9482553740 |
| Fax |
|
| Email |
abhisannatangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prabha Adhikari M.R. |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
| Address |
GERIATRIC MEDICINE,5TH FLOOR- FWING, EMD BUILDING, YENEPOYA MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880991290 |
| Fax |
|
| Email |
prabha.raghuveer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHISHEK B SANNATANGIYAVAR |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
| Address |
GERIATRIC MEDICINE, 5TH FLOOR-F BLOCK, EMD BLOCK, YENEPOYA MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8243506000 |
| Fax |
|
| Email |
geriatricmedicine@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| DR ABHISHEK B SANNATANGIYAVAR |
|
|
Primary Sponsor
|
| Name |
DR ABHISHEK B SANNATANGIYAVAR |
| Address |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL DERALAKATTE MANGALORE. |
| Type of Sponsor |
Private 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 ABHISHEK B SANNATANGIYAVAR |
YENEPOYA MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF GERIATRIC MEDICINE, 5TH FLOOR- F BLOCK, EMD BUILDING.
Dakshina Kannada
KARNATAKA |
8243506000
geriatricmedicine@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G218||Other secondary parkinsonism, (2) ICD-10 Condition: G20||Parkinsons disease, (3) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere, (4) ICD-10 Condition: G219||Secondary parkinsonism, unspecified, (5) ICD-10 Condition: G214||Vascular parkinsonism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MULTICOMPONENT REHABILITATION. |
PHYSIOTHERAPY
OPTIMISING PARKINSONS MEDICATIONS(AS PER SENIOR CONSULTANT /TREATING DOCTOR ORDERS)
SUPPLIMENTNG VITAMIN B12(1000mcg/day) AND VIT D(2000U/day) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients already diagnosed with parkinsonism and peripheral neuropathy.
2. Age more than or equal to 60 years.
3. Who are able to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with major neuro cognitive disorder.
2. Patients with drug induced parkinsonism.
3. Patients of stage Parkinsonism of Hoehn and Yahr classification.
4. Patients who are of multi organ failure and hypoxia.
5. Patients with acute illness and acute infection.
6 Patients of chronic kidney disease on dialysis.
7. Patients who are exposed to neurotoxin or chemotherapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in fall risk in elderly.
|
5days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Improving the balance in elderly.
3. Efficacy of etiology based therapy. |
AT DAY 5 AND AT THE TIME OF DISCHARGE OF THE PATIENT. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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="6"
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
|
- TITLE OF THE RESEARCH
TOPIC: Effect of multicomponent
rehabilitation on fall risk reduction in elderly patient hospitalized with
parkinsonism and peripheral neuropathy.
This study
involves study of geriatric patients/participants with Parkinsonism and its
association with peripheral neuropathy and short term in hospital outcomes. Participants
with previously diagnosed or newly diagnosed parkinsonism, Vascular Parkinsons
or Atypical parkinsonism will be assessed for Peripheral neuropathy and fall
risk. Information regarding neuropathy- treatment based on aetiology,
physiotherapy details and dopaminergic therapy for parkinsonism will be collected.
They are followed up for 5days or until discharge for clinical outcomes -
improvement, worsening or status quo will be noted using Neuropathy disability
score, steady fall risk score and berg balance scale score and timed up and go
test results. Underlying Comorbidities and risk factors will be noted to see
whether there is any association with peripheral neuropathy in parkinsonism |