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 : November 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Brain Injuries | Device: Use of standard standing frame Device: Use of a new device; Innowalk Pro | Not Applicable |
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.
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 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) |
Primary Purpose: | Treatment |
Official Title: | Responses on Use of Standing Frame and "Innowalk Pro" in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury. |
Actual Study Start Date : | October 19, 2020 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Standing frame
Use of standard standing frame
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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 Pro"
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 |
- Standing time in minutes [ Time Frame: Up to one week ]Tolerated maximal standing time in each standing device.
- Blood pressure [ Time Frame: Up to one week ]Blood pressure is monitored continuously
- Heart rate [ Time Frame: up to one week ]Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
- 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.
- 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)
- 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
- Number of patients reporting pain [ Time Frame: up to one week ]Negative impact during training
- Rate of skin issues [ Time Frame: up to one week ]The number of patients reporting
- Number of near faints will be registered by the staff. [ Time Frame: up to one week ]Negative impact during training

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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 |
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

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
Contact: Vivien Jørgensen, phd | +4766969353 | vivien.jorgensen@sunnaas.no | |
Contact: Ellen Høyer, phd | +4766969632 | ellen.hoyer@sunnaas.no |
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 |
Principal Investigator: | Vivien Jørgensen, Phd | Sunnaas Rehabilitaion Hospital |
Publications:
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: | November 14, 2022 |
Last Verified: | November 2022 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
standing blood pressure heart rate surface electromyography of muscles in legs perceived exertion |
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |