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A study comparing 2 types of artificial feet for persons with leg amputation

Performance comparison between IITM developed and commercially available prosthetic foot among persons with unilateral trans-tibial and trans-femoral amputation â?? A Pre-Post Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056315
Enrollment
20
Registered
2023-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z896- Acquired absence of leg above knee Health Condition 2: Z895- Acquired absence of leg below knee

Interventions

Intervention1: IIT-M developed Prosthetic Foot: 4 weeks familiarization time will be given to transtibial users 6 weeks familiarization time will be given to transfemoral users Control Intervention1:

Sponsors

TTK Center for Rehabilitation Research and Device Development, IIT Madras
Lead Sponsor
Mobility India
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-60 years 2. Weight: 40-100 kgs 3. Persons with traumatic trans-tibial unilateral amputation 4. Persons with traumatic trans-femoral unilateral amputation 5. Chronic prosthetic users with transtibial and transfemoral amputation 6. Persons with an amputation due to any etiology 7. Persons with Medicare Functional Classification Level (MFCL) of K2 and K3 8. Persons using Ottobock SACH Foot 9. . Persons with recent amputation (3 to 6 months)

Exclusion criteria

Exclusion criteria: 1. Persons with bilateral amputation 2. Persons with the following medical conditions: a. Chronic heart ailments b. Neurological conditions affecting motor planning and execution c. Postural hypotension d. Impaired sensation e. Clinically confirmed diabetes mellitus f. Unhealed lower limb fractures g. Impaired cognitive and perceptive abilities 3. Persons with unhealed skin injuries at the stump of the amputation site 4. Persons with acute or chronic pain which will get aggravated by activities involved in the testing protocol

Design outcomes

Primary

MeasureTime frame
Kinematic & kinetic parameters using a gait analysisTimepoint: Pre assessment will be done before familiarization & intervention Post assessment will be done after 8 weeks for transtibial users & after 12 weeks for transfemoral users

Secondary

MeasureTime frame
Amputee mobility predictor (AMP)Timepoint: Pre assessment will be done before familiarization & intervention Post assessment will be done after 8 weeks for transtibial users & after 12 weeks for transfemoral users;Locomotor cap abilities index in amputees (LCI)Timepoint: Pre assessment will be done before familiarization & intervention Post assessment will be done after 8 weeks for transtibial users & after 12 weeks for transfemoral users;Qualitative QuestionsTimepoint: Pre assessment will be done before familiarization & intervention Post assessment will be done after 8 weeks for transtibial users & after 12 weeks for transfemoral users;Timed 10-Meter Walk TestTimepoint: Pre assessment will be done before familiarization & intervention Post assessment will be done after 8 weeks for transtibial users & after 12 weeks for transfemoral users;Timed Get Up & Go TestTimepoint: Pre assessment will be done before familiarization & intervention Post assessment will be done after 8 weeks for transtibial users & after 12 weeks for transfemoral users

Countries

India

Contacts

Public ContactDr Sujatha Srinivasan

TTK Center for Rehabilitation Research and Device Development, Indian Institute of Technology Madras

sujsree@iitm.ac.in04422575695

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026