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CTRI Number  CTRI/2024/10/075298 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective cohort 
Study Design  Other 
Public Title of Study   Balance in persons ambulating with unilateral lower limb prosthesis. 
Scientific Title of Study   Incidence of falls and fall risk in persons ambulating with unilateral lower limb prosthesis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PT-Staff2024-2025/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Saravanakumar 
Designation  Physiotherapist 
Affiliation  All India Institute of Physical Medicine and rehabilitation. 
Address  Room no. 204, Physiotherapy department,2 nd floor, All India Institute of Physical Medicine and rehabilitation, Mumbai. KK khadye marg, Hajiali, Mumbai.

Mumbai
MAHARASHTRA
400034.
India 
Phone  09833493029  
Fax    
Email  snehas.pt@aiipmr.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Sneha Saravanakumar 
Designation  Physiotherapist 
Affiliation  All India Institute of Physical Medicine and rehabilitation. 
Address  Room no 204, 2 nd floor, Physiotherapy department, All India Institute of Physical Medicine and Rehabilitation, Mumbai. KK khadye marg, Hajiali, Mumbai.

Mumbai
MAHARASHTRA
400034
India 
Phone  09833493029  
Fax    
Email  snehas.pt@aiipmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Sneha Saravanakumar 
Designation  Physiotherapist 
Affiliation  All India Institute of Physical Medicine and rehabilitation. 
Address  Room no. 204, second floor ,Physiotherapy department All India Institute of Physical Medicine and Rehabilitation,Mumbai. kk khadye marg, hajiali, Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  09833493029  
Fax    
Email  snehas.pt@aiipmr.gov.in  
 
Source of Monetary or Material Support  
All India Institute of Physical Medicine and Rehabilitation,MUMBAI - 400034,Maharashtra, India 
 
Primary Sponsor  
Name  Sneha Saravanakumar 
Address  All India Institute of Physical Medicine and Rehabilitation, KK KHADYE MARG ,MUMBAI 400034. 
Type of Sponsor  Other [Under Ministry of Health and Family welfare, Goverment of India] 
 
Details of Secondary Sponsor  
Name  Address 
Pallavi Kasture  All India Institute of Physical Medicine and Rehabilitation, KK KHADYE MARG ,MUMBAI 400034. 
Sheikh Abdul Khadir  All India Institute of Physical Medicine and Rehabilitation, KK KHADYE MARG ,MUMBAI 400034. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SNEHA SARAVANAKUMAR  All India institute of physical medicine and rehabilitation.  Room no 204, 2nd floor,Department of Physiotherapy. KKKhadye marg,Hajiali,Mumbai-400034
Mumbai
MAHARASHTRA 		 9833493029

snehas.pt@aiipmr.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  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 
Intervention  not applicable  not applicable 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Person, a community ambulator with unilateral lower limb prosthesis, 3 months post completion of rehabilitation program 
 
ExclusionCriteria 
Details  -Person with any central neurological conditions eg: stroke,Parkinsons disease,Spinal cord injury,Multiple scerosis,Hereditary ataxia.
- Persons with cognitive impairment.
- Persons with any psychological disorders.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Gait speed in m/s to assess fall risk in persons with unilateral lower limb prosthesis.
2.Incidence of fall.
 		 1.Gait speed in m/s to assess fall risk in persons with Unilateral lower limb prosthesis prospectivey over a period of 0, 6 and 12 months.  
 
Secondary Outcome  
Outcome  TimePoints 
1. TUG(Timed Up and Go test) score in secs.
2. Fall efficacy scale (FES)score.  		 Both TUG and FES scores to be assessed in persons with unilateral lower limb prosthesis in 0,6 and 12 months propectively. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   28/10/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   Primary purpose of the study : To assess incidence of falls and fall risk among persons ambulating with unilateral lower limb prosthesis.

Objectives : 
1. To assess incidence of falls among persons ambulating with unilateral transfemoral and transtibial prosthesis.
2. To assess fall risk among persons ambulating  with unilateral transfemoral and transtibial prosthesis with low and high speed prospectively over a period of one year (0,6 and 12 months)
3. To compare functional mobility ( outcome measure - TUG in secs  ) and fear of fall ( outcome measure - FES score ) among persons ambulating with unilateral transfemoral and transtibial prosthesis with high and low speed.
 
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