| 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
|
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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 |
|
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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 Abbavaram Johar Myna |
Christian Medical College, Vellore |
Room no. 16 , Physiotherapy OPD Vellore TAMIL NADU |
8309274793
abbavaram.joharmyna.dipahs23@cmcvellore.edu.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z899||Acquired absence of limb, unspecified, |
|
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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 |
|
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Balance using Timed Up And Go Test (TUG) and Modular balance board (MOBBO) |
Day 1 and Day 12 |
|
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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 |
|
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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 |
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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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