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

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Use of standard standing frame
Use of a new device; Innowalk Pro
Sponsored by
Sunnaas Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring standing, blood pressure, heart rate, surface electromyography of muscles in legs, perceived exertion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnaas Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standing frame

"Innowalk Pro"

Arm Description

Use of standard standing frame

Use of a new device; "Innowalk Pro"

Outcomes

Primary Outcome Measures

Standing time in minutes
Tolerated maximal standing time in each standing device.
Blood pressure
Blood pressure is monitored continuously

Secondary Outcome Measures

Heart rate
Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
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.
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)
Perceived exertion
For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion
Number of patients reporting pain
Negative impact during training
Rate of skin issues
The number of patients reporting
Number of near faints will be registered by the staff.
Negative impact during training

Full Information

First Posted
April 28, 2020
Last Updated
April 13, 2023
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Made for Movement
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1. Study Identification

Unique Protocol Identification Number
NCT04452019
Brief Title
Use of Standing Frame and "Innowalk Pro" in Patients With TBI
Official Title
Responses on Use of Standing Frame and "Innowalk Pro" in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Made for Movement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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".
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
standing, blood pressure, heart rate, surface electromyography of muscles in legs, perceived exertion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standing frame
Arm Type
Active Comparator
Arm Description
Use of standard standing frame
Arm Title
"Innowalk Pro"
Arm Type
Experimental
Arm Description
Use of a new device; "Innowalk Pro"
Intervention Type
Device
Intervention Name(s)
Use of standard standing frame
Intervention Description
Two training sessions in a standard standing frame, max 30 min. pr. session
Intervention Type
Device
Intervention Name(s)
Use of a new device; Innowalk Pro
Intervention Description
Two training sessions in Innowalk Pro, max 30 min pr. session
Primary Outcome Measure Information:
Title
Standing time in minutes
Description
Tolerated maximal standing time in each standing device.
Time Frame
Up to one week
Title
Blood pressure
Description
Blood pressure is monitored continuously
Time Frame
Up to one week
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
Time Frame
up to one week
Title
Muscle activity in legs
Description
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.
Time Frame
up to one week
Title
Spasticity
Description
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)
Time Frame
up to one week
Title
Perceived exertion
Description
For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion
Time Frame
up to one week
Title
Number of patients reporting pain
Description
Negative impact during training
Time Frame
up to one week
Title
Rate of skin issues
Description
The number of patients reporting
Time Frame
up to one week
Title
Number of near faints will be registered by the staff.
Description
Negative impact during training
Time Frame
up to one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivien Jørgensen, Phd
Organizational Affiliation
Sunnaas Rehabilitaion Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas Rehabilitation Hospital
City
Nesoddtangen
ZIP/Postal Code
1450
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
21791851
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.
Results Reference
background
PubMed Identifier
30409170
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.
Results Reference
background
PubMed Identifier
24355448
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.
Results Reference
background
PubMed Identifier
27447483
Citation
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.
Results Reference
background
PubMed Identifier
33355016
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. 2023 May;18(4):407-414. doi: 10.1080/17483107.2020.1860143. Epub 2020 Dec 23.
Results Reference
background
Links:
URL
http://bora.uib.no/handle/1956/11981
Description
WESCHE, A.P 2015 Master thesis in Norwegian. "Tidlig mobilisering av voksne pasienter med ervervet hjerneskade ved bruk av "Innowalk Pro".
URL
https://www.madeformovement.com/innowalk-pro
Description
"Innowalk Pro"

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

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