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Prosthesis in traumatic below elbow amputation

A pilot study to evaluate the functionality of Below Elbow Prosthesis (BIONICLI®) for essential Activities of Daily Living (ADL) in below elbow amputees following Trauma - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/062391
Enrollment
5
Registered
2024-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: S581- Traumatic amputation at level between elbow and wrist

Interventions

Intervention1: Below Elbow Prosthesis: myoelectric bionic prosthesis BIONICLI Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

LIFE AND LIMB PRIVATE LIMITED - an IIT Kanpur incubated startup
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18 to 65 years of age All Gender Unilateral below elbow amputees No associated fracture or existing major injury or deformity of the contralateral upper limb Residual Limb or stump length is ? of the opposite forearm No physiological or musculoskeletal issues with normal limb range of motion in both limbs.

Exclusion criteria

Exclusion criteria: Deformity or partial amputation of the other hand Lower limb amputation Patients with major head or spinal cord injuries Scars on the electrode placement site Patients requiring to operate in high-risk environments such as dealing with hot or corrosive fluids or operating high-risk machinery such as agricultural or industrial tools or those intending to drive motor vehicles with the prosthesis

Design outcomes

Primary

MeasureTime frame
Single Upper Extremity Amputation-Activities of Daily Living Questionnaire WHOQOL- BREF Questionnaire Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure EMG MappingTimepoint: Single Upper Extremity Amputation-Activities of Daily Living Questionnaire WHOQOL- BREF Questionnaire Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure EMG Mapping

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Sushma Sagar

AIIMS New Delhi

sagar.sushma@gmail.com9891510122

Outcome results

None listed

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