Use of Standing Frame and "Innowalk Pro" in Patients With TBI
- Conditions
- Brain Injuries
- Interventions
- Device: Use of standard standing frameDevice: Use of a new device; Innowalk Pro
- Registration Number
- NCT04452019
- Lead Sponsor
- Sunnaas Rehabilitation Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description "Innowalk Pro" Use of a new device; Innowalk Pro Use of a new device; "Innowalk Pro" Standing frame Use of standard standing frame Use of standard standing frame Standing frame Use of a new device; Innowalk Pro Use of standard standing frame "Innowalk Pro" Use of standard standing frame Use of a new device; "Innowalk Pro"
- Primary Outcome Measures
Name Time Method Standing time in minutes Up to one week Tolerated maximal standing time in each standing device.
Blood pressure Up to one week Blood pressure is monitored continuously
- Secondary Outcome Measures
Name Time Method Number of near faints will be registered by the staff. up to one week Negative impact during training
Muscle activity in legs 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.
Rate of skin issues up to one week The number of patients reporting
Spasticity 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 up to one week For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion
Heart rate up to one week Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
Number of patients reporting pain up to one week Negative impact during training
Trial Locations
- Locations (1)
Sunnaas Rehabilitation Hospital
🇳🇴Nesoddtangen, Norway