Use of Standing Frame and Innowalk Pro in Patients With TBI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Responses on Use of Standing Frame and Innowalk Pro in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.

Conditions
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Brain Injuries

Intervention / Treatment
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* Device: Use of standard standing frame
* Device: Use of a new device; Innowalk Pro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All together each included patient will attend five sessions. First session includes an orthostatic test and other baseline measurements. In order to describe test-to-test variation (reliability) when using the devices, two sessions are held in standard standing frame (A) and two sessions in Innowalk Pro (B), preferably within the same week. If, for practical reasons, this is not feasible, training is allowed in the following week. The order of the workouts is block randomized to ABAB or BABA at inclusion. The orthostic test and the training session are estimated to last approx. 1 hour including all measurements.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standing frame<br>Use of standard standing frame | Device: Use of standard standing frame<br>* Two training sessions in a standard standing frame, max 30 min. pr. session<br>Device: Use of a new device; Innowalk Pro<br>* Two training sessions in Innowalk Pro, max 30 min pr. session<br>|
| Experimental: Innowalk Pro<br>Use of a new device; Innowalk Pro | Device: Use of standard standing frame<br>* Two training sessions in a standard standing frame, max 30 min. pr. session<br>Device: Use of a new device; Innowalk Pro<br>* Two training sessions in Innowalk Pro, max 30 min pr. session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standing time in minutes | Tolerated maximal standing time in each standing device. | Up to one week | 
| Blood pressure | Blood pressure is monitored continuously | Up to one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000 | up to one week | 
| Muscle activity in legs | Any muscle activity in legs during standing session will be monitored by EMG using Musclelab (from Ergotest Innovations) on vastus medialis, hamstrings, tibialis ant. and gastrocnemius muscles. | up to one week | 
| Spasticity | Spasticity in knee flexors and ankle flexors will be measured by Modified Ashworth scale (0-4 where 0= no increase in tone and 4 = rigid limb) | up to one week | 
| Perceived exertion | For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion | up to one week | 
| Number of patients reporting pain | Negative impact during training | up to one week | 
| Rate of skin issues | The number of patients reporting | up to one week | 
| Number of near faints will be registered by the staff. | Negative impact during training | up to one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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standing, blood pressure, heart rate, surface electromyography of muscles in legs, perceived exertion