Sunnaas Rehabilitation Hospital
Nesoddtangen, 1450, Norway
NCT Number: NCT04452019
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".
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Nesoddtangen, 1450, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two training sessions in a standard standing frame, max 30 min. pr. session
Two training sessions in Innowalk Pro, max 30 min pr. session
Time frame: Up to one week
Tolerated maximal standing time in each standing device.
Time frame: Up to one week
Blood pressure is monitored continuously
Time frame: up to one week
Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
Time frame: up to one week
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.
Time frame: up to one week
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)
Time frame: up to one week
For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion
Time frame: up to one week
Negative impact during training
Time frame: up to one week
The number of patients reporting
Time frame: up to one week
Negative impact during training
Sunnaas Rehabilitation Hospital
Other
Responses on Use of Standing Frame and "Innowalk Pro" in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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