Clinical trial NCT02382991: Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
Official title: Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation of Hip and Thigh, Level Unspecified
Keywords: Moderately active amputees
C-leg Compact
Knee prosthesis
Kenevo
Microprocessor controlled knee
Amputation
3C60
Timed Get Up and Go (TGUG)
Locomotors Capacities Index (LCI)
QUEST
Short Form survey (SF-36)
Lead sponsor: Otto Bock France SNC
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.

The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.

Detailed description: The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing.

After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.

Eligibility criteria: Inclusion Criteria:

* Person with leg amputation above knee or knee disarticulation with stabilized residual limb
* Person who are currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee
* Person with a high risk of falling, which is defined as a TGUG test score of more than 19 seconds
* Person who moves around within buildings other than one's residence, such as moving around other people's homes, other private buildings, community and private or public buildings and enclosed areas, moving throughout all parts of buildings and enclosed areas, between floors, inside, outside and around buildings, both public and private
* Person who moves around outside the home and other buildings, such as walking and moving around close to or far from one's home and other buildings, without the use of transportation, public or private, such as walking for short or long distances around a town or village, walking or moving down streets in the neighbourhood, town, village or city; moving between cities and further distances, without using transportation
* Person with a daily walking distance greater than 300 m

Exclusion Criteria:

* Persons using underarm crutches or walkers
* Persons under 18 years of age
* Persons who weigh more than 125 kg
* Pregnant women
* Persons in an emergency situation
* Persons who cannot personally provide their consent
* Persons who are not available to follow the entire study protocol

Primary outcomes:
measure: Timed Get Up and Go (TGUG)
timeFrame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Secondary outcomes:
measure: Locomotor Capabilities Index (LCI-5)
timeFrame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
measure: Use of Walking Aids
timeFrame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
measure: QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
timeFrame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
measure: SF-36v2™ Health Survey
timeFrame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
measure: Number of Falls
timeFrame: Measurement will be performed at 1 month with both devices
Other outcomes:
Locations:
city: Sankt Andrä am Zicksee
country: Austria
facility: Sonderkrankenanstalt Zicksee
city: Bois Guillaume
country: France
facility: CRMPR "Les Herbiers"
city: Clamart
country: France
facility: Hôpital d'instruction des Armées Percy
city: Concarneau
country: France
facility: Centre Hospitalier de Cornouaille Concarneau
city: Coubert
country: France
facility: Centre de réadaptation de Coubert
city: Echirolles
country: France
facility: CHU de Grenoble Hôpital Sud
city: Marseille
country: France
facility: Clinique Chantecler
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
city: Paris
country: France
facility: Institut National des Invalides
city: Paris
country: France
facility: Hôpital Léopold Belan
city: Rennes
country: France
facility: Pôle Saint-Hélier
city: Saint Priest
country: France
facility: Hôpital privé de l'Est Lyonnais
city: Thionville
country: France
facility: Centre l'Adapt Thionis
city: Valenton
country: France
facility: Institut Robert Merle d'Aubigné
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
Study officials:
affiliation: Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France
name: Gerard Chiesa, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoppen T, Boonstra A, Groothoff JW, de Vries J, Goeken LN, Eisma WH. The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999 Jul;80(7):825-8. doi: 10.1016/s0003-9993(99)90234-4.
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