Stroke
Conditions
Interventions
None listed
Sponsors
Roessingh Research and Development
Eligibility
Inclusion criteria
Inclusion criteria: • Age above 18 years • Willing to provide informed consent • Left unilateral ischemic or haemorrhagic chronic (> 6 months) stroke • Hemiparetic right leg • Problems with stability in stance, insufficient push-off, problems with foot clearance during swing and/or problems with foot prepositioning in early stance. (Nikamp et al., 2018) • Functional Ambulation Categories (FAC) score = 3, participants are able to walk without manual assistance on a flat surface. • Able to walk without walking aids (such as crutch, four-wheeled walker) • Able to read and understand questionnaires and able to understand and execute commands, both in Dutch.
Exclusion criteria
Exclusion criteria: • High levels of spasticity of muscle tone (resistance to passive movement), as represented by modified Ashworth scale scores of 3 or higher • Premorbid disability of lower extremity • Progressive neurological diseases like, dementia or Parkinson • Skin lesions or severely impaired sensation at the hemiparetic leg • Contraindication for mobilization, like lower limb fracture • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome parameter is joint angle of the ankle and knee, derived from the position data in sagittal plane. In other words, the dorsiflexion and plantarflexion in the ankle and the extension and flexion in the knee. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters relating to the gait analysis are spatiotemporal and other kinematic parameters (hip joint angles) and max ground reaction force during push-off. Spatiotemporal parameters entail preferred walking speed, stance duration, swing time, step length etc. The stance duration, swing time and step length will be used to assess the symmetry between both legs. In addition, the heel strike and toe off timing will be determined. The joint angles will be derived from the position data. All measurements will be done for both legs, the affected and non-affected. These parameters will also be used to evaluate to algorithm for gait detection based on IMU and/or foot switches/pressure. Another study parameter of the current study is muscle activity. The muscle activity will be measured of five different muscles per leg. The muscles are rectus femoris, rectus vastus lateralis, tibialis anterior, gastrocnemius medialis and semitendinosus. In addition, the BORG rating scale for perceived exertion (11 points scale) will be administered directly after baseline gait analysis in the first visit and directly upon completion of each conditions of walking with ABLE-S in the second visit (See appendix A for the BORG scale). Furthermore, two questionnaires will be used to evaluate the usability and experience of the patient after walking with the exoskeleton at the second visit. | — |
Contacts
Public ContactCindy Rikhof
Roessingh Research and Development
Outcome results
None listed