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CTRI Number  CTRI/2025/06/088492 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 09/06/2025
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   Effect of task-oriented exercise on arm and hand function in neurological deficit patients: a randomized trial. 
Scientific Title of Study   A randomized control trial to assess the effectiveness of task oriented exercise on arm and hand functions among patients with neurological deficit admitted at selected tertiary care hospitals of Western Maharashtra.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saranya Chandran R 
Designation  PG Trainee 
Affiliation  College of Nursing AFMC Pune 
Address  First Year MSc Nursing Trainee officer, Department of Medical Surgical Nursing, Division - Neurology Nursing , Room No:09 College of Nursing, Armed Forces medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  8547406780  
Fax    
Email  saranyachandru0000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Tulika De Biswas 
Designation  Assistant Professor 
Affiliation  College of Nursing AFMC Pune 
Address  Department of Medical Surgical Nursing, Division - Neurology Nursing, Room No-09 College of Nursing, Armed Forces medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9874243204  
Fax    
Email  tulikadebiswas@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Mrs Saranya Chandran R 
Designation  Saranya Chandran R 
Affiliation  College of Nursing AFMC Pune 
Address  First Year MSc Nursing Trainee officer, Department of Medical Surgical Nursing, Division- Neurology Nursing,Room No-09 College of Nursing, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9874243204  
Fax    
Email  tulikadebiswas@yahoo.com  
 
Source of Monetary or Material Support  
Command Hospital, Southern Command, CME Road, Wanowrie, Pune, Maharashtra 411040 
 
Primary Sponsor  
Name  Saranya Chandran R 
Address  College of Nursing Armed Forces Medical College Solapur Pune Highway Wanowrie Pune 411040 
Type of Sponsor  Other [Self funded] 
 
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 
Ms Saranya Chandran R  Command Hospital  Neurology and Neuro surgery Department Command Hospital Southern Command Golibar Maidan Wanwadi Pune
Pune
MAHARASHTRA 
8547406780

saranyachandru0000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Armed Forces Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G904||Autonomic dysreflexia, (2) ICD-10 Condition: G935||Compression of brain, (3) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (4) ICD-10 Condition: G24||Dystonia, (5) ICD-10 Condition: G900||Idiopathic peripheral autonomic neuropathy, (6) ICD-10 Condition: G938||Other specified disorders of brain, (7) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard therapy  Neurologically deficit patients receives the standard treatment of physiotherapy as prescribed by the physician. 
Intervention  Task Oriented Exercises   Task Oriented Exercises for arm and hand functions of neurologically deficit patient for the experimental group, which includes open a jar of coffee, call 911 in dial phone, draw a line with a ruler, pour a glass of water, wring out washcloth, do up 5 buttons of a shirt and dry back with towel These will be performed by the participants under the supervision of the researcher once daily for 30 minutes for a period of 5 days and thereafter will be asked to continue the intervention under the supervision of a caregiver which will be reinforce through daily phone calls by the investigator and by maintaining daily diary until 02 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with neurological deficit who are:
more than 18 years,
having Chedoke Arm and Hand Activity Inventory score 20 or above (mild to moderate arm and hand dysfunction)
 
 
ExclusionCriteria 
Details  Patients with neurological deficit who are:
not able to comprehend
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
the efficacy of task oriented exercises in terms of arm and hand function score.   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   01/09/2025 
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)   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  

This randomized control trial aims to evaluate the effective ness of task oriented exercises on arm and hand functions of neurologically deficit patients at selected tertiary care hospitals of Western Maharashtra. A total of 60 patients with neurological deficit will be recruited for the study using systematic random sampling. Participants will be randomly allocated into control and intervention group with 30 patients in each group. The intervention group will receive task oriented exercises which will be performed under the supervision of the researcher once daily for 30 minutes for a period of 5 days and thereafter will be asked to continue the intervention under the supervision of a caregiver which will be reinforce through daily phone calls by the investigator and by maintaining daily diary until 02 weeks.  The control group will receive standard physiotherapy alone. Arm and hand function will assessed before and after the intervention by using CAHAI ( Chedoke Arm and Hand Activity Inventory)-7. The study aims to evaluate  the effectiveness of task oriented exercises on arm and hand functions among patients with neurological deficit and also to associate the outcomes with selected socio demographic variables. This research will provide evidence on the effectiveness of task oriented exercises as supportive therapy along with physiotherapy for the patient with neurological deficit.

 

 

 
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