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CTRI Number  CTRI/2025/01/079188 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between videogame exercise when combined with traditional exercises versus traditional exercises alone in individuals with surgical removal of part of the leg, after a newly fit artificial limb  
Scientific Title of Study   Comparison of exergaming when used as an adjunct to conventional therapy in lower limb amputations after prosthetic fitting - A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abbavaram Johar Myna 
Designation  MPT student 
Affiliation  Christian Medical College, Vellore 
Address  Physiotherapy unit, Department of PMR,Christian Medical College, Ida Scudder Road

Vellore
TAMIL NADU
632004
India 
Phone  8309274793  
Fax    
Email  abbavaram.joharmyna.dipahs23@cmcvellore.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Abbavaram Johar Myna 
Designation  MPT student 
Affiliation  Christian Medical College, Vellore 
Address  Physiotherapy unit, Department of PMR,Christian Medical College, Ida Scudder Road

Vellore
TAMIL NADU
632004
India 
Phone  8309274793  
Fax    
Email  abbavaram.joharmyna.dipahs23@cmcvellore.edu.in  
 
Details of Contact Person
Public Query
 
Name  Andrew Babu 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Physiotherapy Unit, Department of PMR, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9489590360  
Fax    
Email  andrewb@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Internal - fluid research grant office of research,Christian Medical College, Ida Scudder Road, Vellore, Tamil Nadu 632004 College campus Tel : 0416-2284294/4289, Hospital campus 0416-3075645, Fax : 0416-2262788, E-mail:research@cmcvellore.ac.in  
 
Primary Sponsor  
Name  Internal - Fluid research grant 
Address  Office of research, Christian Medical College,Ida Scudder Road, Vellore, Tamil Nadu 632004 Tel : 0416-2284294/4289, Hospital campus 0416-3075645, Fax : 0416-2262788, E-mail:research@cmcvellore.ac.in  
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 
Dr Abbavaram Johar Myna  Christian Medical College, Vellore  Room no. 16 , Physiotherapy OPD
Vellore
TAMIL NADU 
8309274793

abbavaram.joharmyna.dipahs23@cmcvellore.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z899||Acquired absence of limb, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy  Participants will undergo conventional therapy for 30 minutes of session per day for 12 days 1st week of therapy : 1. Standing inside parallel bar with Bilateral hand support (in front of mirror): Weight shifting – Mediolateral ;Anteroposterior directions 2. Standing inside parallel bar with Unilateral hand support (in front of mirror): Weight shifting – Mediolateral ;Anteroposterior directions 3. Standing inside parallel bar without hand support (in front of mirror): Weight shifting – Mediolateral and Anteroposterior directions 4. Standing and reaching activities inside parallel bar – multidirectional reaches 5. Marching inside parallel bar with Bilateral Hand support 6. Marching inside parallel bar with Unilateral Hand support 7. Marching inside parallel bar with no Hand support 8. Moving the ball under sound leg inside parallel bar 9. Stool stepping (varying heights) with hand support to no hand support 10. Pivot turning 11. Walking inside parallel bar with bilateral hand support to unilateral hand support : forward, sideways, backward 2nd week of therapy 1. Balance training : Standing on varying surface – trampoline 2. Walking inside parallel bar with no hand support : forward, sideways, backward 3. Walking outside parallel bar with no hand support : forward, sideways, backward 4. Walking outside parallel bar with assistive device to no device 5. Stepping over obstacles 6. Stair climbing, ramp climbing  
Intervention  Exergame and conventional therapy  Participants will undergo both Exergaming and Conventional therapy for 30 minutes of session per day for 12 days. Total number of games are 5. Each game has 2 levels challenging the participant. Game 1: Ball tilt : For Mediolateral shifting Game 2 : Flappy Bird : For Anteroposterior shifting Game 3 : Coin collector : For Marching Game 4 : Ping Pong : For Sideways walking Game 5 : Stepper : For Stepping training 1st week of Conventional therapy : 1. Standing inside parallel bar with Bilateral hand support (in front of mirror): Weight shifting – Mediolateral ;Anteroposterior directions 2. Standing inside parallel bar with Unilateral hand support (in front of mirror): Weight shifting – Mediolateral ;Anteroposterior directions 3. Standing inside parallel bar without hand support (in front of mirror): Weight shifting – Mediolateral and Anteroposterior directions 4. Standing and reaching activities inside parallel bar – multidirectional reaches 5. Marching inside parallel bar with Bilateral Hand support 6. Marching inside parallel bar with Unilateral Hand support 7. Marching inside parallel bar with no Hand support 8. Moving the ball under sound leg inside parallel bar 9. Stool stepping (varying heights) with hand support to no hand support 10. Pivot turning 11. Walking inside parallel bar with bilateral hand support to unilateral hand support : forward, sideways, backward 2nd week of conventional therapy 1. Balance training : Standing on varying surface – trampoline 2. Walking inside parallel bar with no hand support : forward, sideways, backward 3. Walking outside parallel bar with no hand support : forward, sideways, backward 4. Walking outside parallel bar with assistive device to no device 5. Stepping over obstacles 6. Stair climbing, ramp climbing  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Unilateral transtibial & transfemoral amputations
Diabetic, vascular, traumatic & tumor etiology
Patients who underwent pre-prosthetic training and
Patients Post-prosthetic fitting 
 
ExclusionCriteria 
Details  Bilateral amputations
People who are unable to see the screen even with visual aid
Patients Who haven’t undergone pre-prosthetic training
Active wounds in the residual limb 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Balance using Timed Up And Go Test (TUG) and Modular balance board (MOBBO)  Day 1 and Day 12 
 
Secondary Outcome  
Outcome  TimePoints 
Mobility using Amputee Mobility Predictor Assessment Tool (AMPRO)
 
Day 1 and Day 12 
2 Minute Walk Test (2MWT)  Day 1 and Day 12 
Confidence level using Activities-Specific Balance Confidence Scale (ABC)  Day 1 and Day 12 
Symmetry of weight bearing during activity using Modular balance board (MOBBO)  Day 1 and Day 12 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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)  

Unilateral lower limb amputee patients referred to Physiotherapy OPD for prosthetic rehabilitation following prosthetic fitting, will be screened for eligibility by the principal investigator and included after a written consent. Baseline assessment will be performed by a physical therapist (PT1) who will be blinded to the group allocation, which will include assessment of balance using Time Up and Go (TUG) test and Modular balance board (MOBBO); mobility using Amputee Mobility Predictor Rated Outcome (AMPRO) and 2 minute walk test; confidence during activity using Activity Balance Confidence (ABC) scale; symmetry in weight bearing limbs using (MOBBO). Following this participants will be randomly allocated to either conventional or interventional group. One group will receive 2 weeks of conventional prosthetic training while the interventional group will receive 2 weeks of exergaming in addition to conventional therapy.  Games included are ping pong for COP shifting; flappy bird for COP shifting; space shooter for marching and walking. Conventional therapy includes weight shifting exercises, balance exercises, marching, stepping, gait training stair climbing and ramp climbing.

At the end of 12 days the outcomes will be reassessed by physiotherapist (blinded outcome assessor). The data will be analyzed to compare the outcomes following Exergaming and Conventional therapy versus Conventional therapy alone in patients with lower limb amputations.

 
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