| CTRI Number |
CTRI/2025/07/091197 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Impact of Diabetic Peripheral Sensory Dysfunction on Mobility Gait Walking Speed and Balance Performance |
|
Scientific Title of Study
|
Quantifying The Impact Of Diabetic Peripheral Sensory Dysfunction On Neural Mobility Gait Speed And Balance Performance |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amratha G Shetty |
| Designation |
Asso Prof |
| Affiliation |
ALVAS COLLEGE OF PHYSIOTHERAPY |
| Address |
Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9591593863 |
| Fax |
|
| Email |
amrathagshetty@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shreya Bhandari |
| Designation |
Post Graduate |
| Affiliation |
ALVAS COLLEGE OF PHYSIOTHERAPY |
| Address |
Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
8147069080 |
| Fax |
|
| Email |
shreyabhandari75@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shreya Bhandari |
| Designation |
Post Graduate |
| Affiliation |
ALVAS COLLEGE OF PHYSIOTHERAPY |
| Address |
Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
8147069080 |
| Fax |
|
| Email |
shreyabhandari75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada
Monofilament,
Aesthesiometer,
Foam pad |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Shreya Bhandari |
Alvas Health Center |
Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada Dakshina Kannada KARNATAKA |
08147069080
shreyabhandari75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALVAS COLLEGE OF PHYSIOTHERAPY ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having type 2 diabetes more than 3 years and less than 10 year;Individuals with undetected peripheral neuropathy(DPN);Consent to participate in the study;Able to walk without assistive device |
|
| ExclusionCriteria |
| Details |
Previously diagnosed Diabetic neuropathy; Any other neurological disease causing neuropathy or cardiovascular disorders; Any low back related condition causing nerve deficit; Hypomobile or hypermobile lower limb joints; Open foot ulcers or wound; Congenital or acquired deformities of lower limb; Recurrent dizziness and vertigo; History of amputation; Unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Two-point discrimination test useing aesthesiometer
Semmes Weinstein monofilament testing
10 Meter Walk test
Balance Error Scoring System
Neural Mobility test –Tibial nerve and Sural nerve Mobility test
|
After recruitment
Time point 0-Two point discrimination
Time point 1-Monofilament testing
Time point 2- 10 Meter walk test
Time point 3- BESS
Time point 4- Neural mobility test
T0-5min,T1-5min,T2-10min,T3-10min,T4-5min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
23/08/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The
study titled "Quantifying the Impact of Diabetic Peripheral Sensory
Dysfunction on Neural Mobility, Gait Speed, and Balance Performance" aims
to explore how sensory impairments associated with Type 2 Diabetes Mellitus
(T2DM) affect physical performance and neural function. Diabetes mellitus is
known to cause long-term complications, particularly affecting the nervous
system, resulting in peripheral diabetic neuropathy (PDN) in 30–50% of
patients. These complications manifest as sensory and motor dysfunctions such
as reduced tactile discrimination, altered proprioception, muscle weakness, and
impaired gait and balance. The study employs a cross-sectional design with 62
participants diagnosed with T2DM for more than two years but without clinically
diagnosed DPN. Participants will undergo a series of assessments including
two-point discrimination using an aesthesiometer, Semmes Weinstein monofilament
testing for foot sensitivity, a 10-meter walk test for gait speed, neural
mobility tests focusing on the tibial and sural nerves, and the Balance Error
Scoring System (BESS) for balance evaluation. These measures will help
establish correlations between sensory loss and functional impairments in
mobility and balance. The study’s significance lies in identifying early
sensory deficits that could potentially lead to falls and decreased quality of
life, even before full-blown DPN manifests. A detailed review of literature
supports the hypothesis that sensory dysfunction due to diabetes impacts gait
and balance and that neural mobilization techniques may enhance nerve function
and overall mobility. Statistical analysis using Pearson’s correlation will
determine the strength of relationships between sensory impairment and the
measured physical performance outcomes. This research could provide a basis for
preventive and rehabilitative strategies in diabetic individuals, emphasizing
early detection and targeted physiotherapy interventions to maintain functional
independence and reduce fall risk. Ethical clearance, informed consent, and
non-invasive procedures ensure the study’s scientific and ethical integrity. By
linking peripheral sensory dysfunction with neural dynamics and movement
outcomes, this research hopes to contribute meaningfully to the management of
diabetic complications. |