| CTRI Number |
CTRI/2025/08/092373 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| 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
|
Reliability and Validity of Modified Standardized Nine Hole Peg Test |
|
Scientific Title of Study
|
Reliability and Validity of the Modified Standardized Nine Hole Peg Test with an Autotimer a Digital Version |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D MYTHILI |
| Designation |
Principal Research Scholar |
| Affiliation |
The TN Dr MGR Medical University Guindy chennai |
| Address |
Madha college of Physiotherapy kundrathur Chennai
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES
THANDALAM
Thiruvallur
TAMIL NADU
600069
India |
| Phone |
9677073534 |
| Fax |
|
| Email |
drmythuphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V Balchandar |
| Designation |
Principal |
| Affiliation |
The TN Dr MGR Mrdical University, Guindy, Chennai |
| Address |
Jaya college of Physiotherapy Thiruninravur
Jaya college of Physiotherapy
Thiruvallur
TAMIL NADU
602024
India |
| Phone |
9444011343 |
| Fax |
|
| Email |
balaisright@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Kotteeswaran |
| Designation |
Professor |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES THANDALAM |
| Address |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES
THANDALAM
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES
THANDALAM
Thiruvallur
TAMIL NADU
602105
India |
| Phone |
9677073534 |
| Fax |
|
| Email |
k.kotteeswaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| DOR/43637/2023 TBR/Pharmacy/OT/PT The Tn Dr MGR Medical University Guindy Chennai 600032 Tamilnadu India
Jaya college of Paramedical Sciences College of Physiotherapy Thiruninravur 602024 |
|
|
Primary Sponsor
|
| Name |
The TN Dr MGR Medical University |
| Address |
The TN Dr MGR Medical University Guindy Chennai
TAMIL NADU |
| Type of Sponsor |
Government funding agency |
|
|
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 Balchandar V |
Jaya college of Physiotherapy |
Room No 1
Phsiotherapy department
Paramedical Sciences Division
Jaya college of Physiotherapy Thiruninravur 602024
Thiruvallur
TAMIL NADU |
9444011343
balaisright@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Human Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Health individuals both Skilled and unskilled workers of Jaya group of Insitution |
|
| ExclusionCriteria |
| Details |
Persons with history of orthopaedic or neuromuscular that would significantly affect dexterity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to complete the assigned task in completion of Nine hole peg test |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/08/2025 |
| 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="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Abstract:
The coordinated hand
and finger movements to grasp objects and perform tasks is known as manual
dexterity. The study focus to assess validity, Inter-Rater
Reliability, Test-Retest Reliability, compared to traditional Nine Hole Peg
Test with a stopwatch and the dmS-NHPT with an Autotimer. 80 Participants were
included and randomized into two groups. The Group A was tested from Evaluator
I with the dmS-NHPT, with an Autotimer (digital version of modified
standardized Nine hole peg test), and then with tNHPT with stop watch
(traditional Nine Hole peg test) on the same day. Group B was tested by
Evaluator II.10 days after first testing, the second testing is done with the
Evaluators being reversed. Dexterity assessment for healthy individuals assessed and compared with the standard version of Nine Hole Peg Test. The Reliability and Validity of New Version is evaluated.
|