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| Name | Class |
|---|---|
| Made for Movement | OTHER |
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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".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standing frame | Active Comparator | Use of standard standing frame |
|
| "Innowalk Pro" | Experimental | Use of a new device; "Innowalk Pro" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of standard standing frame | Device | Two training sessions in a standard standing frame, max 30 min. pr. session |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivien Jørgensen, Phd | Sunnaas Rehabilitaion Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnaas Rehabilitation Hospital | Nesoddtangen | 1450 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21791851 | Background | Glickman LB, Geigle PR, Paleg GS. A systematic review of supported standing programs. J Pediatr Rehabil Med. 2010;3(3):197-213. doi: 10.3233/PRM-2010-0129. | |
| 30409170 | Background | Riberholt CG, Lindschou J, Gluud C, Mehlsen J, Moller K. Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury - Protocol for a randomised clinical feasibility trial. Trials. 2018 Nov 8;19(1):612. doi: 10.1186/s13063-018-3004-x. |
| Label | URL |
|---|---|
| WESCHE, A.P 2015 Master thesis in Norwegian. "Tidlig mobilisering av voksne pasienter med ervervet hjerneskade ved bruk av "Innowalk Pro". | View source |
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Anonymous IPD will be available on request.
Data will be available when study has been competed.
Requests will be reviewed by the Project group.
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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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.
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| Use of a new device; Innowalk Pro | Device | Two training sessions in Innowalk Pro, max 30 min pr. session |
|
| 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 |
| 24355448 | Background | Riberholt CG, Thorlund JB, Mehlsen J, Nordenbo AM. Patients with severe acquired brain injury show increased arousal in tilt-table training. Dan Med J. 2013 Dec;60(12):A4739. |
| 27447483 | Background | Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016. |
| 33355016 | Background | Piene Wesche A, Strand LI, Jorgensen V, Opheim A, Hoyer E. Early mobilization of a patient with acquired brain injury using a new standing aid, the Innowalk Pro. A single subject experimental design. Disabil Rehabil Assist Technol. 2023 May;18(4):407-414. doi: 10.1080/17483107.2020.1860143. Epub 2020 Dec 23. |
| "Innowalk Pro" | View source |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |