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CTRI Number  CTRI/2024/05/066617 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
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   A Clinical Trial to study effectiveness of functional task oriented training program on upper limb function and quality of life in acute stroke patients 
Scientific Title of Study   EFFECTIVENESS OF STRUCTURED FUNCTIONAL TASK ORIENTED TRAINING PROGRAM ON UPPER LIMB FUNCTION AND QUALITY OF LIFE IN ACUTE STROKE PATIENTS - A RANDOMISED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR.JASMINE SHAIKH 
Designation  PhD Scholar  
Affiliation  RJS COLLEGE OF PHYSIOTHERAPY 
Address  Dr.APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES,LONI BK 413736,TAL-RAHATA,DIST-AHMEDNAGAR,INDIA
Dr.APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES,LONI BK 413736,TAL-RAHATA,DIST-AHMEDNAGAR,INDIA
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09922107731  
Fax    
Email  jasmineshaikh325@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Rakesh Sinha 
Designation  PRINCIPAL & PROFESSOR 
Affiliation  Dr.APJABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES 
Address  Dr.APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES,TAL-RAHATA,DIST-AHMEDNAGAR,LONI BK 413736,INDIA
Dr.APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES, TAL-RAHATA,DIST-AHMEDNAGAR LONI BK
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9799783783  
Fax    
Email  smartphysio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.JASMINE SHAIKH 
Designation  PhD Scholar  
Affiliation  PRAVARA INSTITUTE OF MEDICAL SCIENCES,LONI BK 
Address  Dr.APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES,LONI BK,TAL-RAHATA,DIST-AHMEDNAGAR
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES,LONI BK,TAL-RAHATA,DIST-AHMEDNAGAR
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09922107731  
Fax    
Email  jasmineshaikh325@gmail.com  
 
Source of Monetary or Material Support  
Dr.APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,PRAVARA INSTITUTE OF MEDICAL SCIENCES,LONI 
 
Primary Sponsor  
Name  Dr APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY TAL:RAHATA, DISTRICT: AHMEDNAGAR 
Type of Sponsor  Other [] 
 
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 
DrJASMINE SHAIKH  PRAVARA RURAL HOSPITAL ,PRAVARA INSTITUTE OF MEDICAL SCIENCES  Study will be conducted at INPATIENT DEPARTMENT OF MEDICINE,OPD NO.101,at PRAVARA RURAL HOSPITAL
Ahmadnagar
MAHARASHTRA 		 09922107731

jasmineshaikh325@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALETHICAL COMMITTEE,PRAVARA INSTITUTE OF MEDICAL SCIENCES DEEMED UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Therapy   Group B received conventional therapy which includes the following: Intervention Exercises Range of motion exercises, Strengthening for shoulder, elbow and wrist Active assisted range of motion exercise wherever needed. • Active range of motion exercise. • Goal directed reaching out in different directions Isometric exercise • Movement against gravity. • Movement with resistance applied by free weights or band Grip strengthening exercise Finger metacarpophalangeal flexion and thumb opposition. (Resisted by spring). • Adduction/ Abduction of finger and thumb and thumb opposition resisted by elastic band. • Exercise with soft ball. Proprioceptive neuromuscular facilitation (PNF) • For improving range: PNF patterning (with assistance wherever required) Rhythmic initiation (movement initiation) • For strength: Slow reversal Alternating isometrics Duration of Each Session will be 60 Minutes and will be Performed 3 times a week under the supervision of Physiotherapist. Each Exercise will be performed for 10 minutes and 2 minutes rest will be given after each exercise.  
Intervention  EFFECTIVENESS OF STRUCTURED FUNCTIONAL TASK ORIENTED TRAINING PROGRAM ON UPPER LIMB FUNCTION AND QUALITY OF LIFE IN ACUTE STROKE PATIENTS  Group A: all the patients of group A will be given Task-oriented training for upper limb rehabilitation. Level I :(2-4weeks) 1.EATING 2.WIPING THE TABLE 3.OPENING A BOTTLE: 4.TURNING CARDS 5.COMBING: LEVEL II ( week 4-6) 1)USING A SPOON 2) PICK UP PENS AND PUT THEM IN PEN HOLDER 3. POURING WATER 4. SWITCH ON & OFF 5. PICK UP A TENNIS BALL AND PLACE IT IN A TRAY LEVEL III (6-8weeks): 1)MOVE AND STACK 4 PLASTIC CUPS : 2)FOLDING TOWELS & STACKING THEM 3) DRINKING WATER 4)OPENING DOOR 5) DRESSING Duration of Each Session will be 60 Minutes and will be Performed 3 times a week under the supervision of Physiotherapist. Each task will be performed for 10 minutes and 2 minutes rest will be given after each Task 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient diagnosed with ischemic MCA Stroke.
Patient experienced upper limb Impairment due to Stroke.
Patient with voluntary control grading 2++
ability to understand instructions and follow command,MMSE score more than 24
 
 
ExclusionCriteria 
Details  • Hemodynamic Instability
• Cognitive Impairment
• Psychiatric Disorders
• Recurrent H/O of Stroke
• Any other neurological or musculoskeletal condition that would interfere with upper limb rehabilitation.
.patient not willing to take part in the study
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Chedoke Arm & Hand Inventory
2)Stroke Specific Quality of Life
3)Fugl Meyer Scale 		 Baseline,8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Stroke specific quality of Life  baseline,8 weeks 
 
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)   15/05/2024 
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="3"
Months="0"
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   Notably only 10% post stroke patients shows complete recovery 30% die & 60%suffer from chronic dysfunction, which results in functional dyskinesia .
Task oriented training is repetition of activities mimicking activities of daily life,goal directed practice and repetition are main components in TOT Rehabilitation,which aims to enhance performance on functional activities. Thus ,treatment aims to improve motor functions as patients actively use upper limb on affected side.
 
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