None listed
Conditions
Brief summary
This study will test the effectiveness of an exoskeleton to treat patients that have suffered a STROKE in the acute stage. Patients will be randomly allocated to three groups: Arm1: virtual myoelectric exoskeleton involving active assisted upper limb movements whilst patient is immersed in a virtual reality environment. that requires the patient to interact with a serious game. In addition patients will receive conventional physiotherapy.. Arm2: active upper limb movements whilst the patient is exposed to the illusion caused by a mirror box. In addition patients will perform the same movements performed by patients in arm1 with the exoskeleton but with the assistance of a Physiotherapist rather than the exoskeleton. Arn3: conventional therapy. All interventions will be 50 minutes per day, 5 days a week (Monday to Friday), for 8 weeks.. Interventions will be delivered at the Rehabilitation Unit of a large Hospital by Physiotherapists specialised in neurological rehabilitation. Adherence will be measured as days attending treatment. The effectiveness of the interventions will be measured using several clinical scales, movement of the upper limb and muscle activity of the upper limb. It is hypothesised that patients in arm1 will experience a greater improvement.
Interventions
Arm1: virtual myoelectric exoskeleton involving active assisted upper limb movements whilst the patient is immersed in a virtual reality environment that requires the patient to interact with a serious game. The virtual reality system with a serious game used in this platform is an immersive virtual reality (VR) system with two VR environments: one is a kitchen where the aim is to perform functional tasks such as taking a bottle; the other involves a boat with holes that the patient has to close
Arm1: virtual myoelectric exoskeleton involving active assisted upper limb movements whilst the patient is immersed in a virtual reality environment that requires the patient to interact with a serious game. The virtual reality system with a serious game used in this platform is an immersive virtual reality (VR) system with two VR environments: one is a kitchen where the aim is to perform functional tasks such as taking a bottle; the other involves a boat with holes that the patient has to close to prevent water entry. These two environments are coupled with the electromyography driven exoesqueleton allowing patients to receive assistance with upper limb movements whilst performing tasks in a realistic virtual environment. In addition patients will receive balance and gait reeducation exercises (e.g. standing over an unstable surface; weight transfer between limbs; treadmill walking with feedback and assistance from physiotherapist). Total intervention time is 50 minutes (30 mins with exoskeleton assisted upper limb reeducation in VR environment, 10 minutes gait reeducation, 10 mins balance re-education). Arm2: active upper limb movements whilst the patient is exposed to the illusion caused by a mirror box. In addition patients will perform the same movements performed by patients in arm1 with the exoskeleton but with the assistance of a Physiotherapist rather than the exoskeleton. In addition patients will receive balance and gait reeducation exercises. Total intervention time is 50 minutes (30 mins upper limb re-education with mirror illusion and active assisted movements, 10 mins gait reeducation, 10 mins balance re-education) Arn3: conventional therapy, 50 minutes (30 upper limb re-education involving active and passive movements, 10 minutes gait reeducation, 10 mins balance reeducation). All interventions will be 50 minutes per day, 5 days a week (Monday to Friday), for 8 weeks. Interventions will be delivered at the Rehabilitation Unit of a large Hospital by Physiotherapists specialised in neurological rehabilitation. Adherence will be measured as days attending treatment.
Sponsors
Ana Bengoetxea Arrese
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Patients presenting with an ischemic or haemorrhagic stroke - Minimum of 2 weeks after the stroke - Be able to give consent to participate in the study - Not being able to clean and to dress themselves
Exclusion criteria
- Cerebellar syndrome or bilateral motor deficit - Significant cognitive deficit that impairs comprehension or understanding of the treatment - Other medical problems that impede the implementation of the treatment - Spasticity equal or greater than 3 in the Asworth scale.
Outcome results
None listed