| CTRI Number |
CTRI/2024/07/070854 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing hand sensations in individuals with and without altered nerve mobility |
|
Scientific Title of Study
|
Comparison of hand sensibility and nerve conduction in individuals with and without neurodynamic response of upper limb |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshika Raut |
| Designation |
MPT Student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7758864635 |
| Fax |
|
| Email |
harshika.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh M Balthillaya |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Prabhu B |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Room no. 215 Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986451010 |
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal Academy of Higher Education Manipal 576104 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Harshika Raut |
| Address |
Department of Physiotherapy, Manipal College of Health Professions
Manipal Academy of Higher Education Manipal 576104 Karnataka India |
| Type of Sponsor |
Other [Self- sponsored] |
|
|
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 Harshika Raut |
Kasturba Hospital, Manipal |
N1, First floor, Room Number 101 Baliga Block, Department of Physiotherapy, Kasturba Hospital, Manipal, Udupi, Karnataka
Neuromotor Control Room, CTC block, 3rd Floor, Kasturba Hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
7758864635
harshika.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient relatives and visitors /attendings of physiotherapy department |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Study Group: Participants presenting responses like pain, tingling, and numbness before 30 degrees of end-range elbow extension while performing upper limb neurodynamic test -1 (ULNT-1) sequence.
2. Comparison Group: Participants without any response or response at terminal range of elbow extension while performing ULNT-1 sequence
|
|
| ExclusionCriteria |
| Details |
1. Previous history of upper limb / cervical neural symptoms of pain or dysfunction for last 3 months.
2. Known case of diabetes, thoracic outlet syndrome, brachial plexus injury, spinal cord injury, spinal disorders, cancer, tumors
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Elbow extension angle in degrees in Upper limb neurodynamic test (ULNT 1) , Hand Sensibility Measures includes Vibration Threshold in Volts,
Two Point Discrimination Score 0- 10, Monofilament Testing Score 0-21 and velocity (m/s ), Amplitude (m/s) in Sensory nerve conduction study
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
03/08/2024 |
| 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
|
An altered upper limb neurodynamic testing (ULNT 1) and abnormal nerve conduction serve as early indicators of peripheral neural dysfunctions that may aid in detecting unknown subclinical pathology in healthy adult individual. Also altered
sensibility may also suggest change in sensory nerve fibers but there is dearth
in study comparing the sensory nerve conduction velocity in individuals with
and without altered neurodynamic tension. Therefore study aims to compare hand sensibility measures, including Vibration Threshold, Two-point Discrimination, Monofilament testing, and nerve conduction, in asymptomatic individuals with altered responses to upper limb neurodynamic testing. The study begins with the screening of asymptomatic healthy individuals approached through advertisement flyers distributed at various locations. Written informed consent will be obtained from participants before performing ULNT, after which participants will be categorized into the study or comparison group based on the response to ULNT . Subsequently, hand sensibility measures such as vibration threshold using a bioesthesiometer, two-point discrimination using a Disk-criminator, light touch using monofilament testing, and nerve conduction amplitude and velocity using a Sensory nerve conduction machine will be measured. The study will continue until January 2025. Data obtained will be analyzed using Jamovi 2.3.28. |