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CTRI Number  CTRI/2022/09/045256 [Registered on: 06/09/2022] Trial Registered Prospectively
Last Modified On: 01/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Designing of multipurpose wrist and hand device and testing its effect on wrist function and quality of life in stroke patients with wrist and hand dysfunction-an exploratory study 
Scientific Title of Study   Designing and testing effect of multipurpose wrist and hand device on spasticity, motor function and quality of life in stroke subjects with wrist and hand dysfunction – an exploratory study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Dhanesha  
Designation  Assistant Professor 
Affiliation  Faculty of physiotherapy, Marwadi university, Rajkot  
Address  Ph.D scholar, Faculty of physiotherapy, Marwadi university, Rajkot
201,Madhav,Dwarika Low Rise, B/H Dwarika Heights,Madhapar Chowk,Rajkot
Rajkot
GUJARAT
360003
India 
Phone  8200563648  
Fax    
Email  nidhi.dhanesha112361@marwadiuniversity.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Kakkad PT  
Designation  Guide, principal, Faculty of Physiotherapy, Marwadi University, Rajkot 
Affiliation  Faculty of physiotherapy, Marwadi university, Rajkot  
Address  Guide, principal, Faculty of Physiotherapy, Marwadi University, Rajkot

Rajkot
GUJARAT
360003
India 
Phone  9824415797  
Fax    
Email  ashish.kakkad@marwadieducation.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Kakkad PT  
Designation  Guide, principal, Faculty of Physiotherapy, Marwadi University, Rajkot 
Affiliation  Faculty of physiotherapy, Marwadi university, Rajkot  
Address  Guide, principal, Faculty of Physiotherapy, Marwadi University, Rajkot

Rajkot
GUJARAT
360003
India 
Phone  9824415797  
Fax    
Email  ashish.kakkad@marwadieducation.edu.in  
 
Source of Monetary or Material Support  
Marwadi University, Rajkot, Gujarat, India 
 
Primary Sponsor  
Name  Marwadi UniversitySelf 
Address  MARWADI UNIVERSITY Morbi Road, At &Po. Gauridad, Rajkot 360003, Gujarat, India  
Type of Sponsor  Other [University ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nidhi Dhanesha  Rajkot city from Gujarat state  Faculty of physiotherapy, Marwadi university, Rajkot
Rajkot
GUJARAT 		 8200563648

nidhi.dhanesha112361@marwadiuniversity.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethical Committee(Marwadi University,recognized by the Central Drug Standard Control Organization(CDSCO)Government of India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1  Device training with conventional treatment given conventional treatment - 30 minutes/ session & device training minutes/ session 5 times/ week for 4 weeks and pre and post 4 weeks comparison will be done 
Comparator Agent  Group 2  Conventional treatment 30 minutes/ session 5 times/ week for 4 weeks and pre and post 4 weeks comparison will be done  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a. Patients with > 3 months post-stroke duration.
b. Age group - 40 to 65 years
c. Mini mental scale examination score- >24
d. Skin intact on hemi paretic arm
e. Medically stable
 
 
ExclusionCriteria 
Details  1. MAS ≥ 3
2. Visual Hemi Neglect
3. Other acute injuries to arms or hands
4. IM Botox injections in any UE muscle in the last 3 months
5. Patients with cardiac pacemaker
6. Stroke patients who are not cooperative
7. Stroke patients who have auditory &/or visual deficits.
8. Stroke patients who do not have proper medical History
9. Patients having another neurological deficit with stroke.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modified Tardieu Scale
Fugl Meyer wrist and hand subscale
QUEST (Quebec user evaluation satisfaction with assistive technology)
 		 Pre and post 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
SF-36  Pre and post 4 weeks  
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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   Phase 2 
Date of First Enrollment (India)   01/11/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

•         Ethical Clearance from university.

•         Searching online database and discussion with experts for forming design of Frame, dynamic splint and electrical stimulator.

•         Final design will be given to biomedical engineer and tentative device would be formed by 3 D designing

•         Tentative model will be tested on healthy individuals and discuss with experts

•         After final corrections from design of device trial for its effectiveness would be performed on stroke patients.

•         Subjects assessed for inclusion criteria, information about device and aim of study will be given and informed consent will be taken

•         Baseline assessment for outcome measure i.e. Fugl Meyer, Modified Tardieu scale and SF 36 will be taken

•         Subjects will be divided into 2 groups i.e. Group A and Group B by Random sampling

•         Group A - Conventional treatment

Group B – 45 minutes/ Day task specific training with device along with conventional treatment 

 
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