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CTRI Number  CTRI/2025/10/096421 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
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 BWS treadmill training on physiological recovery and balance, trunk control, gait in patients with moderate to severe head injury 
Scientific Title of Study   Neurophysiological and functional responses to early antigravity training in moderate to severe head injury: A pre-post experimental 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  Sushmitha Naik 
Designation  Post graduate  
Affiliation  Kle Institute of Physiotherapy 
Address  Room no 39 Advance physiotherapy center,Sagar floor, Dr Prabhakar Kore hospital, Nehru nagar, Belagavi, Karnataka, India
Belagavi, Karnataka, 590010, India
Belgaum
KARNATAKA
590010
India 
Phone  8431700543  
Fax    
Email  sushmithanaik879@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjiv Kumar 
Designation  Principal and Professor 
Affiliation  Kle Institute of Physiotherapy 
Address  Room no 39 Advance physiotherapy center,Sagar floor, Dr Prabhakar Kore hospital, Nehru nagar, Belagavi, Karnataka, India
Belagavi, Karnataka, 590010, India
Belgaum
KARNATAKA
590010
India 
Phone  9448745648  
Fax  0831-2474727  
Email  Sanjiv3303@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjiv Kumar 
Designation  Principal and Professor 
Affiliation  Kle Institute of Physiotherapy 
Address  Room no 39 Advance physiotherapy center,Sagar floor, Dr Prabhakar Kore hospital, Nehru nagar, Belagavi, Karnataka, India
Belagavi, Karnataka, 590010,
Belgaum
KARNATAKA
590010
India 
Phone  9448745648  
Fax  0831-2474727  
Email  Sanjiv3303@rediffmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Kle Academy of Higher Education and Research, Belagavi  
Address  Nehru nagar, Belagavi, Karnataka, India  
Type of Sponsor  Research institution 
 
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 
Dr Sanjiv Kumar  KLEs Dr.Prabhakar kore hospital and medical research centre, Belagavi   Room no 39 Advance physiotherapy center,Sagar floor, Dr Prabhakar Kore hospital, Nehru nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA 
9448745648

Sanjiv3303@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S098||Other specified injuries of head,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early antigravity training using treadmill   Antigravity training for 3 consecutive weeks 30 mins session with 5 mins warm up 5 mins cool down 3 days in a week Conventional physiotherapy for 20 mins Post assessment The data collected will be statistically analyzed.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with unstable vital signs, severe cardiopulmonary issues, fractures, contractures, and deformities, uncontrolled seizures, open wounds, severe cognitive impairment, current participation in other rehabilitation trials will be excluded.
 
 
ExclusionCriteria 
Details  Patients with unstable vital signs, severe cardiopulmonary issues, fractures, contractures, and deformities, uncontrolled seizures, open wounds, severe cognitive impairment, current participation in other rehabilitation trials will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional mobility using mFAC
Trunk control using TIS
Balance using BBS and FIST.

 
Baseline and 3 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
Final Enrollment numbers achieved (Total)= "11"
Final Enrollment numbers achieved (India)="11" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/11/2025 
Date of Study Completion (India) 27/02/2025 
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  
TBI frequently leads to severe disruptions in motor control and postural
stability, which requires structured rehabilitation interventions aimed at restoring movement function and promoting patient’s independency.
Conventional rehabilitation techniques, including head-up tilt training, have been widely used to enhance postural stability and facilitate upright tolerance in individuals recovering from TBI. Research indicates that early mobilization via head-up tilt positioning is both safe and practical in TBI patients, in early-phase neurorehabilitation.
Patients with moderate to severe TBI require necessary rehabilitation, beginning in neurocritical care units during hospitalization, continuing through inpatient rehabilitation programs, and extending to post-discharge rehabilitation services.
Tilt table mobilization is commonly introduced as an early intervention for patients with impaired consciousness following inpatient rehabilitation. The primary goals of this approach are to stimulate arousal and prevent secondary complications, such as joint contractures that are associated with prolonged immobility.
Innovative rehabilitation technologies, such as anti-gravity training systems, offer controlled body-weight support, enabling patients to move more freely with minimised stress on the musculoskeletal system. The incorporation of anti-gravity training into rehabilitation has shown notable benefits across diverse patient groups. For example, the AlterG Anti-Gravity Treadmill has been effectively used to enhance mobility, strength, and safety in individuals with neurological conditions such as TBI and stroke. The AlterG Anti-Gravity Treadmill, a specialized device that enables adjustable weight-bearing support, allowing patients to engage in progressive gait training with minimal efforts.
Dynamic body-weight support systems reduce gait and balance demands by partially unloading body weight, enabling safe and effective fall-free walking and balance training, especially for severely impaired patients. Despite its demonstrated benefits in diverse patient groups, the uses of anti-gravity postural training in the early rehabilitation of TBI remains largely unexamined. With these advancements, there remains a limitation of research specifically examining the neurophysiological and functional impacts of dynamic anti-gravity postural training in the early rehabilitation of head injury patients. Addressing this gap is crucial, as early intervention is often necessary. Therefore, a study focusing on this area is warranted to determine the efficacy of anti-gravity training modalities in enhancing neurophysiological responses, improving postural control, and functional recovery in this patient population.
The aim of this study is to evaluate the neurophysiological and functional responses to early antigravity training in moderate to severe head injury patients and objective is to evaluate changes in Orthostatic tolerance, functional mobility using mFAC, trunk control using TIS, and balance using BBS and FIST.

 
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