Evaluation of a Neural-Controlled Powered Prosthesis Across Diverse Real-World Tasks

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMassachusetts Institute of Technology

About this trial

The purpose of this study is to evaluate the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world mobility tasks. This research aims to assess how compare the sense of embodiment with the device, symmetry, and stability of a person with an lower-extremity amputation walking with a bionic prosthesis and their prescribed prosthesis. Findings from this study will inform future developments in bionic prosthesis design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female age 18-70.

The patient must have a unilateral transfemoral amputation .

The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).

The patient must have adequate socket to support the device.

Disqualifiers

Women who are pregnant.

Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).

Trial design

Design model

Single group

Treatments tested in this trial

  • MIT Powered Leg

    Device

    MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: MIT Powered LegExperimental treatment 1 intervention
Group B: Prescribed prosthesisNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Kinematic and Kinetic Measures of Lower-Limb Biomechanics

Quantitative analysis of lower-limb biomechanics, including joint angles, ground reaction forces, joint torques, and mechanical power during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors to evaluate gait symmetry, stability, and mechanical efficiency.

Time frame
An average of 2 sessions in the span of 1 week
2

Spatiotemporal Gait Parameters

Evaluation of spatiotemporal gait parameters during ambulation with the powered prosthesis. Specific measures include stride length, cadence, walking speed, and stance-to-swing ratio. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values

Time frame
An average of 2 sessions in the span of 1 week
3

Assessment of Patient Ability to Control each Joint of the Prosthesis

Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy, latency, and repeatability, evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.

Time frame
An average of 2 sessions in the span of 1 week

Secondary outcomes

Other outcomes

Sponsors and contacts

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