New Microprocessor-Controlled Prosthetic Knee Evaluation

Lower Limb Amputation Above Knee (Injury) Clinical Trial

Official title:

Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017024
• Other study ID #: 2022-A01266-37
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: Proteor Group
• Contact: Laurine Calistri, MS
• Phone: +33779825147
• Email: laurine.calistri[@]proteor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Able to understand and give informed consent

• Man or woman, more than 18 y.o

• Lower limb amputee KD or AKA, unilateral or bilateral

• K3/K4 activity level

• Already fitted with FR-reimbursed MPK

• Being comfortable in their socket (SCS>=5)

Exclusion Criteria:

• Protected person

• Pregnant or breast feeding lady

• Person having pathologies affecting their sensitivity

• Using walking aids

• Weighting more than 136kg

• Insufficient hip joint or pelvic voluntary muscle control

• Insufficient cognitive ability to charge the knee and care for the device

Related Conditions & MeSH terms

• Lower Limb Amputation Above Knee (Injury)

Intervention

Device:
• microprocessor-controlled knee (MPK) assessment
The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests

Locations

Country	Name	City	State
France	Hôpital Léon Bérard	Hyères
France	Clinique du Dr Ster	Lamalou-les-Bains
France	UGECAM Nord-Est IRR	Nancy
France	Centre Mutualiste de Kerpape	Ploemeur
France	UGECAM La Tourmaline	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Proteor Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal goal achievement	Patient-specific Functional Scale - PSFS - [0-10], the higher the better	test sessions 1 and 2 (20 minutes)
Secondary	Functional walking test - mobility capacity	6-minute walk test (6MWT)	test sessions 1 and 2 (8 minutes)
Secondary	Functional walking test - fast walking speed	10-meter walk test (10mWT)	test sessions 1 and 2 (1 minute)
Secondary	Functional test - ability to walk downhill	Hill assessment index (HAI) [0-11], the higher the better	test sessions 1 and 2 (3 minutes)
Secondary	Functional test - ability to walk downstairs	Stairs assessment index (SAI) [0-13], the higher the better	test sessions 1 and 2 (3 minutes)
Secondary	Questionnaire to assess comfort in the socket	Socket comfort score (SCS) [0-10], the higher the better	test sessions 1 and 2 (1 minute)
Secondary	Questionnaire to assess satisfaction	Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better	test sessions 1 and 2 (5 minutes)
Secondary	Questionnaires to assess quality of life	Short Form (36) health survey (SF-36); the higher the better	test sessions 1 and 2 (5 minutes)
Secondary	Prosthesis Evaluation Questionnaire	PEQ, 8 sub-scales [0-100], the higher the better	test sessions 1 and 2 (29 minutes)