| 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
|
|
|
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
|
|
|
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). |