FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/060232 [Registered on: 24/11/2023] Trial Registered Prospectively
Last Modified On: 23/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of concise arm and hand training approach versus a graded repetitive arm supplementary program in improving the function of hand and muscle control of upper limb in stroke: A comparative study  
Scientific Title of Study   Effectiveness of concise arm and hand rehabilitation approach versus graded repetitive arm supplementary program(GRASP) in improving the functional ability of hand and gross & fine motor control of upper limb in stroke- A comparitive 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  MythiliG 
Designation  Lecturer 
Affiliation  BLDE(deemed to be university),Shri B. M. Patil medical hospital and Research centre. 
Address  OPD NO-14, Department of physiotherapy, Shri B.M. Patil medical college hospital and research Centre, BLDE(deemed to be university), Bangaramma Sajjan campus, Vijayapura,

Bijapur
KARNATAKA
586103
India 
Phone  8870496063  
Fax    
Email  mythiliganesh.physio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPrathap suganthirababu 
Designation  professor and vice principal 
Affiliation  Saveetha college of physiotherapy 
Address  Saveetha college of physiotherapy saveetha Nagar Thandalam chennai

Chennai
TAMIL NADU
600128
India 
Phone  9840340195  
Fax    
Email  prathap.scpt@saveetha.com  
 
Details of Contact Person
Public Query  
Name  DrPrathap suganthirababu 
Designation  professor and vice principal 
Affiliation  Saveetha college of physiotherapy 
Address  Saveetha college of physiotherapy saveetha Nagar Thandalam chennai

Chennai
TAMIL NADU
600128
India 
Phone  9840340195  
Fax    
Email  prathap.scpt@saveetha.com  
 
Source of Monetary or Material Support  
shri.B. M. Patil Medical college and hospital, BLDE(Deemed to be university) 
 
Primary Sponsor  
Name  Nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
DrG MYTHILI   BLDE (DEEMED TO BE UNIVERSITY) SHRI B.M PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE  OPD -14, Department of physiotherapy, shri B.M.Patil medical college, hospital and research centre,Bangaramma Sajjan campus, vijayapura
Bijapur
KARNATAKA 		 8870496063

mythiliganesh.physio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BLDE(DEEMED TO BE UNIVERSITY)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G89-G99||Other disorders of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Concise arm and hand rehabilitation approach  It is structured framework of exercise for the patient with difficulty in upper limb function. In this exercise include based on the grade in which the patient belong. And the treatment include 1.taking care and prevention of complication. 2.task oriented arm hand skill performance 3.functional performance. The treatment duration is 1hr in a day for 5 days in a week for 4 weeks. 
Intervention  Graded repetitive arm supplementary program.  It is structured framework of exercise for the patient with difficulty in upper limb function. In this exercise is divided into 5 sections 1. stretching 2.arm strengthening 3.hand strengthening 4.co-ordination 5.hand skills. The treatment duration is 1hr in a day for 5 days in a week for 4 weeks. 
Comparator Agent  PRE AND POST TEST of the intervention  In this we are finding the effectiveness of both the intervention. and compare both the intervention of concise arm and hand rehabilitation approach and graded repetitive arm supplementary program. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  participants who are in 1-4 weeks post stroke with upper limb weakness are taken for the study.
participants who were clinically stable are taken for the study. 
 
ExclusionCriteria 
Details  participants having history of trauma, surgery, acute infection, orthopedics deformity, cervical pathology, peripheral neurological diseases, unstable health condition, who are not willing to participate and uncooperative individual.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
functional ability of hand- fugel meyer assessment
 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
gross & fine motor control of upper limb- Block & box test
fine motor control of upper limb- nine hole peg test 		 4 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/12/2023 
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 Yet Recruiting 
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   concise arm and hand rehabilitation approach and graded repetitive arm supplementary program is relatively new concept developed to promote upper extremity recovery in stroke patients. There are only a few studies that have to investigated the effect of concise arm and hand rehabilitation approach and graded repetitive arm supplementary program in improving the functional ability on upper limb   and gross and fine motor control on upper limb in stroke patients and the less number of articles related to comparison of concise arm and hand rehabilitation approach and graded repetitive arm supplementary program  in improving functional ability of hand and gross and fine motor control on upper limb in stroke. thus the need of the study is to compare the effectiveness of concise arm and hand rehabilitation approach and graded repetitive arm supplementary program in improving the functional ability of hand and gross and fine motor control on upper limb in stroke. 
Close