| CTRI Number |
CTRI/2024/10/075069 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Wristwell: recovery and strengthening device |
|
Scientific Title of Study
|
Designing and developing an innovative device for strengthening wrist flexors and extensors group of muscle- A multiphase 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 |
Kalariya Swati |
| Designation |
Post Graduate Student |
| 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 |
8140949928 |
| Fax |
|
| Email |
skalariya536@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Doshi |
| Designation |
Assistant Professor , School pf 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 |
7405346112 |
| Fax |
|
| Email |
komal.doshi@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Doshi |
| Designation |
Assistant Professor , School pf 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 |
7405346112 |
| Fax |
|
| Email |
komal.doshi@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalariya Swati Maheshbhai School of Physiotherapy , RK University, kasturbadham, Rajkot-Jamnagar Highway, Rajkot, Gujarat |
|
|
Primary Sponsor
|
| Name |
Kalariya Swati |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| School of Physiotherapy RK University |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalariya Swati |
RK Physiotherapy Rehabilitation and Research center |
Physiotherapy Department, Room no. 1, opp Meghani rang bhuvan, Bhaktinagar circle Rajkot
Rajkot
GUJARAT |
8140949928
skalariya536@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: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Wrist strengthening device |
This device is for wrist muscle. Device will be given for 5 days per week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Person with wrist flexors and extensors group of muscle |
|
| ExclusionCriteria |
| Details |
1) Fracture of upper limb
2) Nerve injury of upper limb
3) Tendon Rupture of wrist muscle |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Manual Muscle Testing |
pre outcome at first day (baseline)before treatment and post outcome at the last day of training after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/12/2024 |
| 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="3"
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
|
Title: Designing and Devloping an innovative device for strenghthening wrist flexors and extensors group of muscles - A multiphasic exploratory study Investigators : Kalariya Swati Maheshbhai; PT, Dr. Komal Doshi; MPT, School of Physiotherapy, RK University. Background : Wrist joint also referred to as the radiocarpal joint is a condyloid synovial joint of the distal upper limb that connects and serves as a transition point between the forearm and hand. function of the wrist joint is to provide range of motion necessary to adequately perform daily functions while maintaining a physiologic level of inherent stability. Muscles in the forearm control wrist movement. The body of each muscle is located proximally in the forearm, and their tendons extend distally across the wrist joint. Their actions can group muscles associated with the wrist joint. They are essential for a wide range of activities involving hand and wrist movements from everyday tasks to complex sports and artistic performance. This muscle are important for the movement, dexterity , grip , stability and coordination of wrist .Wrist muscle weakness can arise from various causes and significantly affect daily functioning.
|