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CTRI Number  CTRI/2024/03/063541 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Balance and Gait Training in patients with Transtibial Amputation 
Scientific Title of Study   Effectiveness of balance and gait training on transtibial amputees coming to PRH: A Pilot 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  Leher Manish Tiwari 
Designation  PG Student 
Affiliation  Pravara Institute of Medical Sciences  
Address  404 P2A Silver Oak Platinum Ahead HP Gas Agency Pimpalwadi Road Shirdi Rahata

Ahmadnagar
MAHARASHTRA
423109
India 
Phone  9004943666  
Fax    
Email  lehertiwari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhpreet Pabla 
Designation  Assisstant Professor 
Affiliation  DR APJABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  OPD NO 403 Department of Orthopedic Physiotherapy fourth floor DR APJ Abdul Kalam College Of Physiotherapy

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  963829927  
Fax    
Email  pablasukhpreet27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sukhpreet Pabla 
Designation  Assisstant Professor 
Affiliation  DR APJABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  OPD NO 403 Department of Orthopedic Physiotherapy fourth floor DR APJ Abdul Kalam College Of Physiotherapy


MAHARASHTRA
413736
India 
Phone  963829927  
Fax    
Email  pablasukhpreet27@gmail.com  
 
Source of Monetary or Material Support  
Pravara Institute of Medical Sciences (Deemed University) Loni Tal Rahata Dist Ahmednagar (Maharashtra) Pin 413736 India 
 
Primary Sponsor  
Name  DR APJ Abdul Kalam College of Physiotherapy 
Address  DR APJ Abdul Kalam College of Physiotherapy Tal Rahata Dist Ahmednagar 413736  
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 
LEHER MANISH TIWARI  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY  OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY FOURTH FLOOR DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY
Ahmadnagar
MAHARASHTRA 		 9004943666

lehertiwari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE OF INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S899||Unspecified injury of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention Group  Phase 1 - 1-4 sessions Exercise Duration- 40 minutes/session Resistance training 10 RM target 1. Hip abduction in side lying 2. Hip extension in prone lying 3. Hamstring curls in prone lying 4. Hip Adduction in side lying 5. Pelvic Bridging 6. Tibialis anterior (of sound leg) in long sitting using theraband 7. Plantarflexors in standing with support performing heel raises 8. Minisquats (without resistance) Phase 2 (5th -8th session) • Balance 1. Sit to Stand with arms crossed over the torso 2. Standing on BOSU disc with the sound leg with continuous visual feedback. 3. Weight shifts on sound leg with (pelvis squared) 4. Side Stepping on towards the sound leg 5. 30 seconds eyes closed challenge 6. Perturbations to improve stepping, ankle and hip strategies 7. Equal weight bearing on both limbs followed by catching a ball • Gait 1. Asking the patients walk on mat with appropriate foot prints in a parallel bar. 2. Step up with initiating the sound leg and step down using the affected limb. 3. Tandem walking 4. Walking with therapist supervision and following appropriate commands. Phase 3 (9th to 12th session) • Balance 1. Standing on BOSU disc with the prosthetic limb bearing weight. 2. Ball rolling exercise (patient will roll a ball which is placed under the sound limb while bearing complete weight on the prosthetic limb) 3. Goal oriented task i.e. asking the patient to touch a pint in all directions using the sound leg while bearing weight on the prosthetic leg 4. Lateral stepping towards the prosthetic side. • Gait 1. Initiate to stair climbing using by stepping with the prosthetic limb before followed by the sound limb 2. Obstacle walking (placing cones or any tiny object and asking the patient to avoid the obstacle) 3. Making sharp turns (at 180 degree)  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants with Unilateral Transtibial Amputation
2. Aged between 25 to 60 years
3. Males and females
4. 1 year post amputation
5. AMPPRO – K1-K3 Level
 
 
ExclusionCriteria 
Details  1. Bilateral Transtibial Amputation
2. AMPPRO level: K4
3. Un healed scar tissue.
4. Recent Surgical Interventions
5. Co-morbidities affecting the everyday physical activity of the patient.
• Unstable Prosthetic Fit

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale
AMPPRO
Timed up and Go Test
 		 Baseline
4th week
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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   N/A 
Date of First Enrollment (India)   11/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   NEED FOR STUDY
Literature suggests higher prevalence of transtibial amputation in India.
Individuals with transtibial amputations often face challenges in maintaining optimal balance and gait, impacting their overall mobility and quality of life. While prosthetic advancements have improved functional outcomes, there is a paucity of research specifically addressing the effectiveness of balance and gait training interventions in this population. 
This study aims to explore the potential benefits of targeted balance and gait training in enhancing the functional capabilities of transtibial amputees receiving care at a tertiary center.
AIM
To Determine The Effectiveness Of The Balance And Gait Training Programme Amongst Transtibial Amputees Coming to Tertiary Care Hospital.
Objectives
1.To study the effectiveness of balance and gait training in transtibial amputees.
2.To determine the functional status of pre and post training in transtibial amputees using the Amputee Mobility Predictor (AMPPRO)
3.To evaluate the risk of fall pre and post training in transtibial amputees using the timed up and go test (TUG)

INCLUSION CRITERIA

·Participants with Unilateral Transtibial Amputation
·Aged between 25 to 59 years
·Males and females
·1 year post amputation
·AMPPRO – K1-K3 Level

Exclusion criteria:

Participants excluded will be:

·       Bilateral Transtibial Amputation

·       AMPPRO level: K4

·       Un healed scar tissue.

·       Recent Surgical Interventions

·       Co-morbidities affecting the everyday physical activity of the patient.

·       Unstable Prosthetic Fit


Outcome measures used for this study will be as follows,

·       Pain- measured with Visual Analogue scale, the reliability value r = 0.81- 0.99.

·       Functional status- measured with Amputee Mobility Predictor (AMPPro), the test-retest reliability r= 0.81- 0.89.

·       Fall risk- measured with Timed Up and Go test 


Phase 1

Exercise Duration

•        40 minutes/session

•        Resistance training

•        10 RM target

EXERCISE PROTOCOL

 1.     Hip abduction in side lying

2.     Hip extension in prone lying

3.     Hamstring curls in prone lying

4.     Hip Adduction in side lying

5.     Pelvic Bridging

6.     Tibialis anterior (of sound leg) in long sitting using theraband

7.     Plantarflexors in standing with support performing heel raises

8. Minisquats (without resistance)

Phase 2 (5th -8th session)

·        Balance

1.      Sit to Stand with arms crossed over the torso

2.      Standing on BOSU disc with the sound leg with continuous visual feedback.

3.      Weight shifts on sound leg with (pelvis squared)

4.      Side Stepping on towards the sound leg

5.      30 seconds eyes closed challenge

6.      Perturbations to improve stepping, ankle and hip strategies

7.      Equal weight bearing on both limbs followed by catching a ball

 

·       Gait

1.     Asking the patients walk on mat with appropriate foot prints in a parallel bar.

2.     Step up with initiating the sound leg and step down using the affected limb.

3.     Tandem walking

4.     Walking with therapist supervision and following appropriate commands.

 Phase 3 (9th to 12th session)

·       Balance

1.     Standing on BOSU disc with the prosthetic limb bearing weight.

2.     Ball rolling exercise (patient will roll a ball which is placed under the sound limb while bearing complete weight on the prosthetic limb)

3.     Goal oriented task i.e. asking the patient to touch a pint in all directions using the sound leg while bearing weight on the prosthetic leg

4.     Lateral stepping towards the prosthetic side.


 GAIT  TRAINING 

  1. Initiate to stair climbing using by stepping with the prosthetic limb before followed by the sound limb
  2. Obstacle walking (placing cones or any tiny object and asking the patient to avoid the obstacle)
  3. Making sharp turns (at 180 degree)

 


 
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