C-BRACE Versus SCO in Community Ambulators

Otto Bock Healthcare (Ottobock)

Status: Completed

Conditions: Lower Limb; Pareses

Treatments: Device: C-BRACE; Device: SCO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05332509

BP-11-PT007

2022-A00116-37 (Other Identifier)

Details and patient eligibility

About

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 ambulators using a Stance Control Orthosis.

Full 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. The eCRF (electronic Case Report Form) assigns the enrolled patient into one group for the trial (C-BRACE/SCO or SCO/C-BRACE), in a randomized order. The assessments are performed after 2 month follow-up period with each orthosis with a minimal wash-out period of 2 weeks.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

C-BRACE/SCO

Experimental group

Description:

The patient is first fitted during 2 months with the C-BRACE orthosis, them, after 2 weeks wash-out period, the patient is fitted with its Stance Controlled Orthosis (SCO).

Treatment:

Device: C-BRACE

Device: SCO

SCO/C-BRACE

Other group

Description:

The patient is using its Stance controlled orthosis (SCO) during 2 months, then, after 2 weeks wash-out period, the patient is fitted with the C-BRACE orthosis.

Treatment:

Device: C-BRACE

Device: SCO