Non-invasive measurement of kinetic information and intervention experiments for smooth assistance with powered prostheses.

JRCT ID: jRCT1030230374

Registered date:29/09/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy people and single thigh amputees
• Date of first enrollment: 29/09/2023
• Target sample size: 150
• Study type: Interventional

Intervention(s)

1. Explain the content of the experiment orally and in writing (approx. 10 mins).
2. In the case of a single thigh amputee, ask the participant to complete a questionnaire on user characteristics (about 30 minutes).
3. The prosthetic leg is attached to the amputated right or left leg of the participant. In the case of able-bodied participants, it is randomly decided which leg is worn, the knee is bent and the leg is attached by means of a band. The participant is asked whether he or she would prefer to have the band applied by an experimenter of the same gender, and if so, the experimenter of the same gender applies the band. After the band is worn, the data from each measurement is composed (approximately 10 min).
4. In the case of a healthy participant, walking practice is conducted to familiarise the participant with the prosthetic leg (about 20 minutes).
5. The IMU sensor is used to measure data in the sitting, standing and walking positions, respectively, at rest, in motion and during locomotion. Measurements are taken in multiple trials. Each session lasts approximately 40 seconds and consists of 60 trials. The total duration is approximately 60 minutes, with a break in the middle. The task differs depending on whether it is the even or odd-numbered trial: in the even-numbered trial, the participant rises from a chair, walks 1.8 m on a flat surface, ascends and descends a ramp with a horizontal distance of 2.5 m, walks again 1.8 m on a flat surface and then sits on a chair. On odd-numbered occasions, the exercise sequence consisted of standing up from a chair, walking 1.8 m horizontally, ascending and descending six flights of stairs, walking 1.8 m horizontally again, and then sitting in a chair. Participant groups are randomly divided and each group ascends and descends stairs of different heights (130 mm, 150 mm and 170 mm) and ramps of different slopes (5, 10 and 15 degree). Assistance is also provided by the powered prosthesis during the movement sequence. The experiment will be filmed with a video camera.
6. After the measurements are completed, the band and prosthesis are removed (approximately 10 minutes).
7. After confirming that there is no effect from the measurements, the experiment is terminated.

Outcome(s)

• Primary Outcome: Motion recognition performance using acceleration and angular velocity information

Secondary Outcome

1. Differences in discrimination performance due to different heights and inclinations
2. Differences in discrimination performance between normal subjects and single thigh amputees

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Able-bodied persons and single femoral amputees who are able to obtain written consent from the individual to participate in the research of their own free will
2. Persons aged between 18 and 80 years at the time consent is obtained
3. Gender: any gender
4. Weight: less than 100 kg
5. Height: between 145 cm and 185 cm.

Exclude criteria

1. Women who are pregnant or may become pregnant.
2. Persons who do not have the ability related to the movement being measured
3. Persons who have difficulty walking with a prosthesis
4. Persons with a history of neurological disorders including epilepsy.

Related Information

• Primary Sponsor: Kanoga Suguru
• Source(s) of Monetary Support: JST-Mirai Program