| 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
|
|
|
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
|
|
|
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
|
|
|
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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