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

NCT04452019 | Completed

• 1 other identifier: REK106287
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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".

Conditions

Brain Injuries

Keywords

standing; blood pressure; heart rate; surface electromyography of muscles in legs; perceived exertion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Heart rate

  up to one week

• Muscle activity in legs

  up to one week

• Spasticity

  up to one week

• Perceived exertion

  up to one week

• Number of patients reporting pain

  up to one week

Study Arms (2)

Standing frame

ACTIVE COMPARATOR

Use of standard standing frame

Device: Use of standard standing frame; Device: Use of a new device; Innowalk Pro

"Innowalk Pro"

EXPERIMENTAL

Use of a new device; "Innowalk Pro"

Device: Use of standard standing frame; Device: Use of a new device; Innowalk Pro

Interventions

Use of standard standing frame DEVICE

Two training sessions in a standard standing frame, max 30 min. pr. session

"Innowalk Pro"; Standing frame

Use of a new device; Innowalk Pro DEVICE

Two training sessions in Innowalk Pro, max 30 min pr. session

"Innowalk Pro"; Standing frame

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Tolerate 5 minutes in 40 degrees 'upright' position in tilt table (custom orthostasis test)
• Body weight ≤95 kg
• Body height ≤190 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• Made for Movement: collaborator

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, 1450, Norway

Location

Related Publications (5)

• 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.

  PMID: 21791851 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.

  PMID: 30409170 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.

  PMID: 24355448 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.

  PMID: 27447483 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.

  PMID: 33355016 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Vivien Jørgensen, Phd

  Sunnaas Rehabilitaion Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: June 30, 2020
• Study Start: October 19, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 14, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available when study has been competed.
• Access Criteria: Requests will be reviewed by the Project group.

Locations

NO (1)