| CTRI Number |
CTRI/2024/10/075560 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Designing and Developing an Easy-to-use hand Grip Strengthening Device With Real-Time Feedback for hand dysfunction |
|
Scientific Title of Study
|
Designing and Developing of Multifunctional Hand grip Strength and Biofeedback Device: A Multiphasic Exploratory Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhvani Nimavat |
| Designation |
Post Graduate Studenet |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
7874059594 |
| Fax |
|
| Email |
dnimavat805@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sojitra MPT PT |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9427110124 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dhvani Nimavat |
| Designation |
Post Graduate Studenet |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
7874059594 |
| Fax |
|
| Email |
dnimavat805@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of physiotherapy RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India. 360020 |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy RK University |
| Address |
kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.360020. |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhvani Nimavat |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy Department, Room no.1, opp Meghani rang bhuvan, Bhaktinagar Circle Rajkot, Gujarat, India
Rajkot
GUJARAT |
7874059594
dnimavat805@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M70-M79||Other soft tissue disorders, (3) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, (4) ICD-10 Condition: M70||Soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multifunctional hand grip strength and Biofeedback Device |
This device is designed to improve multifunctional hand grip strength and provide biofeedback during a 5 Days a week for 2-week rehabilitation program. It focuses on training both power grips (cylindrical, spherical, hook, and lateral grips) and precision grips (pad-to-pad, tip-to-tip, and pad-to-side). The device monitors grip strength and real time biofeedback helping users enhance hand function. The training progressively challenges users to develop both grip strength for everyday tasks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria for the study required participants to be between the age of 18 and 60 years. consent form was obtained in writing. Wrist Related Musculoskeletal and Neurological conditions which affect the grip. |
|
| ExclusionCriteria |
| Details |
Recent surgery or injury in upper limb
Open wound in upper limb
Psychiatric illness
Non co-operative subjects
Amputation in upper limb
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Hand Dynamometer
2) Sollerman Hand Function Test |
Pre outcome at Base line (first day of treatment) and post outcome after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/10/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Designing and Developing of Multifunctional Hand Grip Strength and Biofeedback Deviceâ€: A Multiphasic Exploratory Study
Background: Prehension activities of the hand involve the grasping or talking object between any two surface in the hand; the thumb participates in the most but not all prehension task. The gripping and wrist actions share several muscles; flexor digitorum profundus (FDP) and flexor pollicis longus (FPL) contribute to wrist flexion and grip force production, while extensor digitorum communis (EDC) contributes to wrist extension and grip relaxation. The bellies of these muscles are located in the forearm, their tendons cross the wrist joint and insert at the base of the distal phalanges. Prehension can be categorized as either power grip or precision handling.
The finger in power grip usually function in concert to clamp on and hold an object into palm. The palm is likely to contour to the object as the palmar arches from around it. When the thumb is involved , it generally is adducted to clamp the object to the palm. Precision grip is defined as the act of grasping an object between the opposed tips of the thumb and index finger, and is vital for performance of skilled hand movements required for everyday function. Method: Following ethical approval, 40 subjects will be selected as per inclusion and exclusion criteria. The outcome measure will be assessed before treatment with hand dynamometer and sollerman hand functional test. and post treatment assessment will be taken with the same outcome measure after 2 weeks.
The Study is divided into three phases: Phase 1: Designing Multifunctional Hand Grip Strength and Biofeedback Device. Phase 2: Developing Multifunctional Hand Grip Strength and Biofeedback Device. Phase 3: Testing Multifunctional Hand Grip Strength and Biofeedback Device. |