FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066886 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 04/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of lower limb task based training on balance and walking confidence in home walkers with paralysis 
Scientific Title of Study   Effectiveness Of Lower Limb Task Specific Progressive Training On Balance And Ambulatory Confidence In Home Ambulatory Persons With Stroke. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nupur Nitin Sahasrabudhe  
Designation  Postgraduate 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  First floor, Department of Neurophysiotherapy,Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12,Thube Park, Shivaji Nagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  9594870072  
Fax    
Email  nupurnsahas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radha Bhattad  
Designation  Professor and HOD of Neuro Physiotherapy  
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  First floor, Department of Neurophysiotherapy, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  9860542511  
Fax    
Email  drradhabhattad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radha Bhattad  
Designation  Professor and HOD of Neuro Physiotherapy  
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  First floor, Department of Neurophysiotherapy,Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  9860542511  
Fax    
Email  drradhabhattad@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  
 
Primary Sponsor  
Name  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005 MAHARASHTRA 
Type of Sponsor  Private medical college 
 
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 
DrNupur Nitin Sahasrabudhe   Sancheti Institute for Orthopaedics and Rehabilitation  First floor, Department of Neurophysiotherapy,Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 11/12, Thube park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA 		 9594870072

nupurnsahas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee  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  Lower Limb Task Specific Progressive Training along with conventional training.  Pre-assessment or the baseline data of the recruited subjects will be taken by a blinded assessor, and will include Dynamic Gait Index (DGI),Activity Specific Balance Confidence Scale (ABC scale) and Ambulation Self Confidence Questionnaire(ASCQ) of all the participants. Participants will be randomly allocated into experimental and control group using computer generated random table method. The experimental group will receive Lower limb task specific training program for 45 min 3 days/week for 6 weeks. Control group will receive conventional treatment for 45 min 3 days/week for 6 weeks. Post intervention assessment with said outcome measures will be noted by the blinded assessor. Data obtained will be analysed and appropriate statistical analysis will be performed. 
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients having greater than or equal to level 2 on modified Hoffer functional ambulation scale which states waling is only possible indoors on flat, horizontal surfaces usually within a known controlled area such as in home. And ability to understand simple verbal commands MMSE score greater than or equal to 23 
 
ExclusionCriteria 
Details  Diagnosis of stroke with any other neurological disorder affecting balance (Multiple sclerosis, Vestibular disorder, Parkinson, Impaired vision)
History of any recent surgery of lower limb. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Activity specific balance confidence scale
2. Ambulation Self confidence questionnaire 		 At baseline(0 weeks) and after intervention(after 6 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Dynamic Gait Index  At baseline (0 weeks) and after intervention after 6 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 14/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Stroke survivors report the importance of real-world walking in creating freedom from dependence which can lead to significant psychological and health benefits. 8 Being able to go outside is perceived as very important by most home dwelling stroke survivors.
Only 40-50% are actually walking independently in the community. Task related training (TRT) or task oriented physiotherapy is a treatment technique that involves the performance of repeated work; aim oriented, purposeful activities in a normal setting.And it tries to improve balance and functional level with mobility to do ADLs properly and reduce impairment related to balance functional status and mobility. 
A few studies have actually focused on lower extremity task-oriented training which can help them facilitate to perform daily functional ambulance and balance tasks and help them achieve community participation. 
Hence, this study will be conducted to study the effectiveness of lower limb Task specific progressive training on balance and ambulatory confidence in home ambulatory persons with stroke.
 
Close