Use of Standing Frame and "Innowalk Pro" in Patients With TBI

Sunnaas Rehabilitation Hospital

Status: Completed

Conditions: Brain Injuries

Treatments: Device: Use of standard standing frame; Device: Use of a new device; Innowalk Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT04452019

REK106287

Details and patient eligibility

About

This study will explore physical and physiological responses to mobilization of patients with acquired brain injuries in subacute phase using a classic standing frame and a standing device with simultaneous passive movement of legs, "Innowalk Pro".

Full description

Several studies underline the importance of early mobilization of patients with brain injuries, leading to shorter hospital stays, less contractures, and improved general function.

The routine mobilization treatment in the rehabilitation of patients with severe brain injuries in Sunnaas Rehabilitation Hospital is initial use of a tilt table where tilt angle is gradually increased, and when tolerated, standing in a classic standing frame where the patient's lower body is fixed to the device in an upright standing position.

"Innowalk Pro" is a robotic standing device where legs are fixed, but passively moved by electric motors in an upright standing position. An assumption is that standing in "Innowalk Pro" might be better tolerated at an earlier stage of rehabilitation than standing in a classic standing frame.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe brain injury / stroke <1 year post injury.
• Medically stable
• Paresis in lower extremities, minimal walking function (even with personal assistance) (FIM movement (walk), score 1-2)
• Planned stay in Sunnaas RH for a minimum of 2 weeks from time of inclusion
• Tolerate 5 minutes in 40 degrees 'upright' position in tilt table (custom orthostasis test)
• Body weight ≤95 kg
• Body height ≤190 cm

Exclusion criteria

• Fractures in the lower extremities or in the columna with movement or strain restrictions or with pain.
• Aggressive and provocative behavior that affects the ability to collaborate.
• Other conditions where upright position is contraindicated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Standing frame

Active Comparator group

Description:

Use of standard standing frame

Treatment:

Device: Use of standard standing frame

Device: Use of a new device; Innowalk Pro

"Innowalk Pro"

Experimental group

Description:

Use of a new device; "Innowalk Pro"

Treatment:

Device: Use of standard standing frame

Device: Use of a new device; Innowalk Pro