An interventional study of Use of standard standing frame and Use of a new device; Innowalk Pro in Brain Injuries, sponsored by Sunnaas Rehabilitation Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Sunnaas Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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".
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 18 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Sunnaas Rehabilitation Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of standard standing frame
Device: Use of standard standing frame · Device: Use of a new device; Innowalk Pro
Use of a new device; "Innowalk Pro"
Device: Use of standard standing frame · Device: Use of a new device; Innowalk Pro
Two training sessions in a standard standing frame, max 30 min. pr. session
Two training sessions in Innowalk Pro, max 30 min pr. session
Standing time in minutes
Tolerated maximal standing time in each standing device.
Time frame: Up to one week
Blood pressure
Blood pressure is monitored continuously
Time frame: Up to one week
Heart rate
Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
Time frame: 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.
Time frame: 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)
Time frame: up to one week
Perceived exertion
For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion
Time frame: up to one week
Number of patients reporting pain
Negative impact during training
Time frame: up to one week
Rate of skin issues
The number of patients reporting
Time frame: up to one week
Number of near faints will be registered by the staff.
Negative impact during training
Time frame: up to one week
Plan to share: Yes — Anonymous IPD will be available on request.
Supporting information: Study protocol, Icf
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Sunnaas Rehabilitation Hospital