Brain Injuries
Conditions
Keywords
standing, blood pressure, heart rate, surface electromyography of muscles in legs, perceived exertion
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.
Interventions
DEVICEUse of standard standing frame
Two training sessions in a standard standing frame, max 30 min. pr. session
DEVICEUse of a new device; Innowalk Pro
Two training sessions in Innowalk Pro, max 30 min pr. session
Sponsors
Made for Movement
Sunnaas Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of skin issues | up to one week | The number of patients reporting |
| Number of near faints will be registered by the staff. | up to one week | Negative impact during training |
| Number of patients reporting pain | 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. |
Countries
Norway
Outcome results
None listed