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CTRI Number  CTRI/2025/02/080077 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 12/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effectiveness of a Single Session of Biomechanically Augmented Balance Training on Gait in Individuals with Stroke: A Pre-Post Study 
Scientific Title of Study   Responsiveness of Gait Assessment and Intervention Tool score towards Single Session Biomechanically Augmented Balance Training in Individuals with Stroke: A Pre-Post 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  Dr. Nang Lonhom Chakhap 
Designation  Post Graduate Student 
Affiliation  Sikkim Manipal College of Physiotherapy 
Address  Sikkim Manipal College of Physiotherapy, Dept. of Physiotherapy, Room no. 505, Sikkim Manipal University, Upper Tadong, 5th Mile, Gangtok, Sikkim

East
SIKKIM
737102
India 
Phone  8787332387  
Fax    
Email  nanglonhomc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saumen Gupta PhD 
Designation  Associate Professor 
Affiliation  Sikkim Manipal College of Physiotherapy 
Address  Sikkim Manipal College of Physiotherapy, Dept. of Physiotherapy, Room no.- 505 Sikkim Manipal University, Upper Tadong, 5th Mile, Gangtok, Sikkim

East
SIKKIM
737102
India 
Phone  9647797497  
Fax    
Email  saumen.g@smims.smu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aksheta Thapa 
Designation  Lecturer 
Affiliation  Sikkim Manipal College of Physiotherapy 
Address  Sikkim Manipal College of Physiotherapy, Dept. of Physiotherapy, Room no.- 505 Sikkim Manipal University, Upper Tadong, 5th Mile, Gangtok, Sikkim

East
SIKKIM
737102
India 
Phone  9083005189  
Fax    
Email  aksheta.t@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Central Referral Hospital, 5th Mile, Tadong, East Sikkim, India, 737102 
Sir Thutop Namgyal Memorial Hospital, Sunagava, East Sikkim, India, 737101 
 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nang Lonhom Chakhap  Central Referral Hospital  Central Referral Hospital, Dept. of Physiotherapy, Room no.- 505, 5th Mile, Tadong, EAST SIKKIM, India, 737102
East
SIKKIM 
8787332387

nanglonhomc@gmail.com 
Dr Nang Lonhom Chakhap  Sir Thutob Namgyal Memorial Hospital  Sir Thutob Namgyal Memorial Hospital, Dept. of Physiotherapy, Room no.-506, Sungava, EAST SIKKIM, India, 737101
East
SIKKIM 
8787332387

nanglonhomc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
SIR THUTOP NAMGYAL MEMORIAL HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   Approved 
SMIMS INSTITUTION ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balance Training  Videos will be taken from frontal (front/back) and sagittal (lateral) views using two cameras: one stationary 3m from the walkway and the other at the end of the 10m path. Both cameras will focus on joint movements. The test will occur in a well-lit 5m-wide, 10m-long walkway. In the pre-test, participants will walk at a self-selected pace without the augmentation device. For training, they will wear the device and weight cuffs on the affected limb, performing balance exercises and walking in multiple directions (forward, backward, sideways) for 10 meters. In the post-test, weight-bearing asymmetry will be noted, and gait videos will be recorded again without the device. Gait analysis will be done using Kinovea software and scored on the G.A.I.T. measures Frequency- 0 Total duration of such intervention- 1 hour per participant  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Both Ischemic & Hemorrhagic stroke
Sub-Acute and Chronic stroke
Age: 18-80
All genders
Modified Ranking Scale: 1-3
 
 
ExclusionCriteria 
Details  Coexistence of other diseases of the CNS e.g. Parkinson’s disease, Alzheimer’s diseases

Injuries affecting loco motor mobility (fractures, sprains)

Inability to maintain an erect body posture for at least 30 sec
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gait Assessment and Intervention Tool (G.A.I.T.)
Asymmetry index for calculation of weight bearing asymmetry (AI)  
Pre post study (on the same day)
Pre test, followed by wash out period of 5 mins and Post test. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2025 
Date of Study Completion (India) 01/05/2025 
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
Modification(s)  

In this study all the in-patients and out-patients diagnosed with Stroke and referred by the Physician for Physiotherapy was recruited as participants for the study. Patients was recruited confirming the eligibility criteria of the study and informed about the study and informed consent was taken prior to baseline assessments. Baseline assessment was taken prior to the test, after that weight bearing asymmetry was checked using the clinical method. Then participants was prepared for G.A.I.T. Reflective marking tapes was placed on the bony landmarks (acromion process, lateral epicondyle, anterior superior iliac spine, posterior superior iliac spine, iliac crest, greater trochanter, lateral & medial condyle of tibia, apex of patella, medial & lateral malleolus and 1st & 5th metatarsal head) to aid for scoring from the video. Videos were recorded using two cameras positioned at frontal (anterior/posterior) and sagittal (lateral) views. One camera was placed 3 meters lateral to the mid-walkway on a stationary tripod, while the other was positioned at the end of a 10-meter walkway. Both cameras were focused to capture all relevant joints. Recordings took place in a well-lit, spacious area (5m × 10m) as shown in Figure 2. During the pre-test, participants walked the 10-meter path at a self-selected pace without the augmentation device. For training, participants used the augmentation device with weight cuffs on the affected limb, performing directional leg movements (AP, AM, AL, PA, PL, PM) and drag-walked forward, backward, and sideways. In the post-test, gait was reassessed without the device, and weight-bearing asymmetry was noted. Gait videos were analyzed using Kinovea software for 2D motion analysis, and scored using the G.A.I.T. (Gait Assessment and Intervention Tool).


 
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