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Brain InjuriesNCT04452019

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

A study testing Use of standard standing frame and Use of a new device; Innowalk Pro in people with Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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". Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Brain Injuries
What is being tested?
Use of standard standing frame and Use of a new device; Innowalk Pro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteNorway
Study dates
19 Oct 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Sunnaas Rehabilitation Hospital

    Nesoddtangen, 1450

Other trials in Norway

About this study

Official title: 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".

Read the 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.

Conditions
Brain Injuries
Being tested
Use of standard standing frame, Use of a new device; Innowalk Pro
Keywords
standing, blood pressure, heart rate, surface electromyography of muscles in legs, perceived exertion
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of standard standing frameDevice

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

  • Use of a new device; Innowalk ProDevice

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

Study groups in NCT04452019
Study groupRoleWhat they receive
Standing frameActive comparatorUse of standard standing frame
Receives: Device: Use of standard standing frame; Device: Use of a new device; Innowalk Pro
"Innowalk Pro"ExperimentalUse of a new device; "Innowalk Pro"
Receives: Device: Use of standard standing frame; Device: Use of a new device; Innowalk Pro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Standing time in minutes

    Tolerated maximal standing time in each standing device.

    Measured: Up to one week

  2. Blood pressure

    Blood pressure is monitored continuously

    Measured: Up to one week

Secondary outcomes (7)

  1. Heart rate

    Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000

    Measured: up to one week

  2. 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.

    Measured: up to one week

  3. 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)

    Measured: up to one week

  4. Perceived exertion

    For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion

    Measured: up to one week

  5. Number of patients reporting pain

    Negative impact during training

    Measured: up to one week

  6. Rate of skin issues

    The number of patients reporting

    Measured: up to one week

  7. Number of near faints will be registered by the staff.

    Negative impact during training

    Measured: up to one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start19 Oct 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452019
Sponsor's protocol ID
REK106287
Status last verified
Nov 2022
First submitted
28 Apr 2020
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymous IPD will be available on request.

Publications

  • 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.

    PubMed 21791851

  • 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.

    PubMed 30409170

  • 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.

    PubMed 24355448

  • 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.

    PubMed 27447483

  • 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.

    PubMed 33355016

Questions about this trial

What is this clinical trial studying?

A study testing Use of standard standing frame and Use of a new device; Innowalk Pro in people with Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standing time in minutes (time frame: Up to one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04452019, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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