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

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

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".

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Device: Use of standard standing frame; Device: Use of a new device; 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivien Jørgensen, phd; Phone Number: +4766969353; Email: vivien.jorgensen@sunnaas.no
• Study Contact Backup: Name: Ellen Høyer, phd; Phone Number: +4766969632; Email: ellen.hoyer@sunnaas.no

Study Locations

• Norway
  • Nesoddtangen, Norway, 1450
    • Sunnaas rehabilitation hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standing frame; Use of standard standing frame	Device: Use of standard standing frame; Two training sessions in a standard standing frame, max 30 min. pr. session; Device: Use of a new device; Innowalk Pro; Two training sessions in Innowalk Pro, max 30 min pr. session
Experimental: "Innowalk Pro"; Use of a new device; "Innowalk Pro"	Device: Use of standard standing frame; Two training sessions in a standard standing frame, max 30 min. pr. session; Device: Use of a new device; Innowalk Pro; Two training sessions in Innowalk Pro, max 30 min pr. session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Sunnaas Rehabilitation Hospital
• Collaborators: Made for Movement

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: blood pressure; heart rate; perceived exertion; standing; surface electromyography of muscles in legs
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: REK106287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous IPD will be available on request.
• IPD Sharing Time Frame: Data will be available when study has been competed.
• IPD Sharing Access Criteria: Requests will be reviewed by the Project group.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No