Use of Standing Frame and "Innowalk Pro" in Patients With TBI

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452019
• Other study ID #: REK106287
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Device:
• Use of standard standing frame
Two training sessions in a standard standing frame, max 30 min. pr. session
• Use of a new device; Innowalk Pro
Two training sessions in Innowalk Pro, max 30 min pr. session

Locations

Country	Name	City	State
Norway	Sunnaas Rehabilitation Hospital	Nesoddtangen

Sponsors (2)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	Made for Movement

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View 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. — View 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. 2020 Dec 23:1-8. doi: 10.1080/17483107.2020.1860143. Online ahead of print. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standing time in minutes	Tolerated maximal standing time in each standing device.	Up to one week
Primary	Blood pressure	Blood pressure is monitored continuously	Up to one week
Secondary	Heart rate	Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000	up to one week
Secondary	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
Secondary	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
Secondary	Perceived exertion	For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion	up to one week
Secondary	Number of patients reporting pain	Negative impact during training	up to one week
Secondary	Rate of skin issues	The number of patients reporting	up to one week
Secondary	Number of near faints will be registered by the staff.	Negative impact during training	up to one week

External Links

•   "Innowalk Pro"
•   WESCHE, A.P 2015 Master thesis in Norwegian. "Tidlig mobilisering av voksne pasienter med ervervet hjerneskade ved bruk av "Innowalk Pro".