Trials Sponsors Conditions Drugs Pricing

Conditions

Lower Limb Amputation Above Knee (Injury)

Outcome Measures

Primary Outcomes (1)

Change in 6 Minute Gait Test
A measure of walking endurance, the distance walked in meters after 6 minutes.
Baseline and after acclimation period (30-90 days after fitting)

Secondary Outcomes (9)

Change in 10 Meter Gait Test
Baseline and after acclimation period (30-90 days after fitting)
Change in Stairs Assessment Index (SAI)
Baseline and after acclimation period (30-90 days after fitting)
Change in Hill Assessment Index (HAI)
Baseline and after acclimation period (30-90 days after fitting)
Change in Four Step Square Test (FSST)
Baseline and after acclimation period (30-90 days after fitting)
Change in Activities-specific Balance Confidence (ABC) Scale
Baseline and after acclimation period (30-90 days after fitting)
+4 more secondary outcomes

Study Arms (2)

C-Leg 3, then C-Leg 4

EXPERIMENTAL

Participants are first fitted with a C-Leg 3, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 4, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.

Device: C-Leg 4Device: C-Leg 3

C-Leg 4, then C-Leg 3

EXPERIMENTAL

Participants are first fitted with a C-Leg 4, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 3, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.

Device: C-Leg 4Device: C-Leg 3

Interventions

C-Leg 4Device

Microprocessor Controlled Knee

C-Leg 3, then C-Leg 4C-Leg 4, then C-Leg 3

C-Leg 3Device

Microprocessor Controlled Knee

C-Leg 3, then C-Leg 4

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Person is \>18 years old.
Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.

Sponsors & Collaborators

Otto Bock Healthcare Products GmbH
Industrylead

Study Sites (2)

Orthopedic Rehabilitation Center SKA Zicksee

Sankt Andrä am Zicksee, Burgenland, 7161, Austria

University Leuven

Pellenberg, 3212, Belgium

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

From 11 subjects that participated in the study, only 7 followed protocol. From post-hoc power analysis, 22 subjects would be required for 80% power to detect a difference of 35.9m (standard deviation = 30.3m) in the 6MWT. Patients were aware that a walking speed of greater than 0.8 m/s was a prerequisite for study participation, which could have lead to bias (elevated baseline measurement) and explain the small change in observed walking speed with C-Leg 3 and C-Leg 4 compared to baseline.

Results Point of Contact

Title: Director of Clinical Research and Services Vienna
Organization: Otto Bock Healthcare GmbH

Study Officials

Stephan Domayer, Prim.Dr.
Orthopedic Rehabilitation Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 6, 2016

Study Start

April 2016

Date type not reported

This date has not been verified as actual or estimated.

C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

C-Leg 3, then C-Leg 4

C-Leg 4, then C-Leg 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

C-Leg 3, then C-Leg 4

C-Leg 4, then C-Leg 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations