Status:
COMPLETED
C-BRACE Versus SCO in Community Ambulators
Lead Sponsor:
Otto Bock France SNC
Collaborating Sponsors:
EVAMED
Conditions:
Lower Limb
Pareses
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this multicentric study is to assess the impact of C-BRACE on mobility, endurance, confidence, participation, satisfaction, psychosocial adjustment and quality of life in community ambu...
Detailed Description
During two months of inclusion period, the investigators invite all patients matching with inclusion criteria for an enrolment visit, collect written consent and record general patient information. Th...
Eligibility Criteria
Inclusion
- person with knee locking deficiency
- person using a SCO (Stance Control Orthosis) for at least three months, walking with a swing phase on a flat ground, without walking aid or with one cane or one crutch.
- person having the ability to walk at 3km/h (measured with 10 meters walk test) with the SCO in unlocked mode.
- person with a stable stance phase on the contralateral side
Exclusion
- person with deficient or unstable contralateral knee, including person using a Knee-Ankle Foot Orthosis on the contralateral limb
- person walking using two canes, two crutches, one or two underarm crutches or a walker
- person with health condition not compatible with the study protocol
- person under 18 years old
- person unwilling / unable to follow the entire study protocol / instructions
- person who did not give her written consent to participate to the study or unable to personally give her consent
- person with knee and/or hip flexion contracture \>10°
- person with genu varum / valgum \> 10° (not reducible)
- person with moderate to severe spasticity
- person with leg length discrepancy \> 15cm
- person who necessitate the use of an orthoprosthesis
- person with body weight \> 125kg
- person with unstable trunk in standing position
- person with cognitive impairments
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05332509
Start Date
April 19 2022
End Date
April 17 2023
Last Update
June 23 2023
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
CRF Korian Le Mont Veyrier
Argonay, France
2
Centre Jacques Calvé Fondation Hopale
Berck, France
3
HIA Percy
Clamart, France
4
Pôle de Réadaptation de Cornouaille
Concarneau, France