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Use of Standing Frame and Innowalk Pro in Patients With TBI

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ClinicalTrials.gov Identifier: NCT04452019
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Made for Movement
Information provided by (Responsible Party):
Sunnaas Rehabilitation Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Injuries Device: Use of standard standing frame Device: Use of a new device;Innowalk Pro Not Applicable

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 pasient'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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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 table (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)
Primary Purpose: Treatment
Official Title: Responses on Use of Standing Frame and Innowalk Pro in Subacute Patients With Severe Functional Deficits Due to Aquired Brain Injury.
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. Standing time in minutes [ Time Frame: Up to one week ]
    Tolerated maximal standing time in each standing device.

  2. Blood pressure [ Time Frame: up to one week ]
    Blood pressure is monitored continuously


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: up to one week ]
    Heart rate will be monitored continously 5 minutes before and during intervention with Polar 5000

  2. Muscle activity in legs [ Time Frame: up to one week ]
    Any muscle activity in legs during standing session will be monitored by EMG using Musclelab (Ergotest Innovations) on vastus medialis, hamstrings, tibialis ant. and gastrocnemius muscles

  3. Spasticity [ Time Frame: up to one week ]
    Spasticity in knee flexors and ankle flexors will be mearured by Modified Ashworth scale (0-4 where 0= no increase in tone and 4 = rigid limb)

  4. Percieved exertion [ Time Frame: up to one week ]
    For patients who are cognitive capable, percieved exertion willl be registrated on Borg Scale of percived exertion

  5. number of patients reporting pain [ Time Frame: up to one week ]
    Negative impact during training

  6. rate of skin issues [ Time Frame: up to one week ]
    The number of patients reporting

  7. number of near faints will be registered by the staff. [ Time Frame: up to one week ]
    Negative impact during training


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452019


Contacts
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Contact: Vivien Jørgensen, phd +4766969353 vivien.jorgensen@sunnaas.no
Contact: Ellen Høyer, phd +4766969632 ellen.hoyer@sunnaas.no

Locations
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Norway
Sunnaas Rehabilitation Hospital Recruiting
Nesoddtangen, Norway, 1450
Contact: Vivien Jørgensen, phd    004766969353    vivien.jorgensen@sunnaas.no   
Contact: Alhed P Wesche, Msc    004792413875    alhed.piene.wesche@sunnaas.no   
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
Made for Movement
Investigators
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Principal Investigator: Vivien Jørgensen, Phd Sunnaas Rehabilitaion Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT04452019    
Other Study ID Numbers: REK106287
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous IPD will be available on request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available when study has been competed.
Access Criteria: Requests will be reviewed by the Project group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnaas Rehabilitation Hospital:
standing
blood pressure
heart rate
surface elektromyography of muscles in legs
percieved exertion
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System