| CTRI Number |
CTRI/2026/02/104997 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| 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
|
To show the effects of Vestibular Exercises on Balance Among Individuals with Diabetic Peripheral Neuropathy:An RCT |
|
Scientific Title of Study
|
Effects of Vestibular Rehabilitation on Balance Among Individuals with Diabetic Peripheral Neuropathy An RCT |
| 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 Megha kumari PT |
| Designation |
PG student |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Department of Physiotherapy
Room no-21
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India
Department of Physiotherapy
Room no-21
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India.
New Delhi
DELHI
110002
India |
| Phone |
7835857896 |
| Fax |
|
| Email |
kmegha638@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Vats Phd |
| Designation |
Lecturer PT |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India
New Delhi
DELHI
110002
India |
| Phone |
9891182228 |
| Fax |
|
| Email |
manju.vats@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha kumari PT |
| Designation |
MPT student |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India
New Delhi
DELHI
110002
India |
| Phone |
7835857896 |
| Fax |
|
| Email |
kmegha638@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) ] |
|
|
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 kumari PT |
Pt. Deendayal Upadhyaya National Institute For Persons with Physical Disabilities(Divyangjan) |
Department of physiotherapy
Room no-21
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)
4, Vishnu Digamber Marg,
Near Mandi House,
New Delhi - 110002,
Delhi, India
New Delhi
DELHI |
7835857896
kmegha638@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDUNIPPD Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional balance exercises |
Conventional exercises that includes Breathing exercise, functional balance training, balance training on wobble board and gait training. The interventions will be provided 4 times/week, for 4 weeks. |
| Intervention |
Vestibular exercises along with conventional exercise |
The treatment consists of conventional physiotherapy exercises along with vestibular rehabilitation exercises such as gaze stabilization, head movements, and postural control training, administered for 4 weeks to improve balance and reduce fall risk in individuals with diabetic peripheral neuropathy. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus
Onset greater than 5yrs
Michigan neuropathy scale greater than 2
Patient has not taken any physiotherapy regarding the same.
Berg Balance Scale less than 45
BMI less than 30
Fasting blood sugar between 130-200 gram per decilitre for atleast 6 months on stable condition or HbA1c greater than 7 percent.
|
|
| ExclusionCriteria |
| Details |
Any musculoskeletal disorder that may affect balance
Recent fracture or any soft tissue injury in lower limb
Any contracture or deformities of lower limb
Any known neurological and intellectual disorder
Diabetic foot ulcer
History of any known recent cardiovascular complication
Any hearing or visual deficit
Walking with the help of assistance or walking aids
BPVV or Vertigo (using Dix Hallpike test
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance |
2 Points(Baseline and after 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Balance related Functional Mobility |
Baseline to After 4 weeks |
| Level of Confidence in Balance |
Baseline to After 4 weeks |
| Quality of Life |
Baseline to After 4 weeks |
| Postural stability in anteroposterior (AP) and mediolateral (MP) displacements with eyes open and eyes closed. |
Baseline to After 4 weeks |
|
|
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)
|
10/03/2026 |
| 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="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
|
Diabetic peripheral neuropathy is associated with balance impairment and increased fall risk. Balance control depends on somatosensory, visual, and vestibular inputs, but vestibular components are often neglected in rehabilitation. This randomized controlled trial evaluates the effectiveness of vestibular rehabilitation combined with conventional physiotherapy compared to conventional physiotherapy alone in individuals with diabetic peripheral neuropathy. Thirty participants will be randomly allocated into two groups and receive intervention for four weeks. Outcome measures include balance, functional mobility, balance confidence, postural sway, and quality of life. The findings may support incorporating vestibular rehabilitation into standard balance training programs for individuals with diabetic peripheral neuropathy.
|