Clinical trial NCT04452019: Use of Standing Frame and "Innowalk Pro" in Patients With TBI
Official title: Responses on Use of Standing Frame and "Innowalk Pro" in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: standing
blood pressure
heart rate
surface electromyography of muscles in legs
perceived exertion
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Made for Movement
First posted: 2020-06-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Standing time in minutes
timeFrame: Up to one week
measure: Blood pressure
timeFrame: Up to one week
Secondary outcomes:
measure: Heart rate
timeFrame: up to one week
measure: Muscle activity in legs
timeFrame: up to one week
measure: Spasticity
timeFrame: up to one week
measure: Perceived exertion
timeFrame: up to one week
measure: Number of patients reporting pain
timeFrame: up to one week
measure: Rate of skin issues
timeFrame: up to one week
measure: Number of near faints will be registered by the staff.
timeFrame: up to one week
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas Rehabilitation Hospital
Study officials:
affiliation: Sunnaas Rehabilitaion Hospital
name: Vivien Jørgensen, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.