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Completed

NCT Number: NCT04452019

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

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".

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnaas Rehabilitation Hospital

Nesoddtangen, 1450, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of standard standing frame

Device

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

Use of a new device; Innowalk Pro

Device

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

Primary outcomes

  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 outcomes

  1. Heart rate

    Time frame: up to one week

    Heart rate will be monitored continuously 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" (from "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 measured by Modified Ashworth scale (0-4 where 0= no increase in tone and 4 = rigid limb)

  4. Perceived exertion

    Time frame: up to one week

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

Sponsors and collaborators

Lead sponsor

Sunnaas Rehabilitation Hospital

Other

Collaborators

  • Made for Movement

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2020
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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