Status:
ENROLLING_BY_INVITATION
Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning
Lead Sponsor:
National Institute for Medical Rehabilitation, Hungary
Collaborating Sponsors:
Semmelweis University
Conditions:
Stroke
Gait Disorders, Neurologic
Eligibility:
All Genders
40-75 years
Brief Summary
High-tech therapy, an innovative field of neurorehabilitation, has expanded rapidly in recent years. Advances in technology have enabled the use of devices that can assist with movement development fr...
Detailed Description
The main objective of this research is to investigate the effectiveness of rehabilitation programmes in post-stroke rehabilitation using advanced technology-based therapy to assist in relearning walki...
Eligibility Criteria
Inclusion
- Hemiparetic patient who has had a stroke;
- ischaemic or haemorrhagic stroke confirmed by CT or MRI;
- female or male between 40 and 75 years of age;
- subgroup 1: less than 3 months since stroke,
- subgroup 2: more than 3 months but less than 1 year since stroke;
- physical fitness adequate for the exertion of the treatment;
- right or left lower limb involvement;
- score 3 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate on a level surface without manual contact of another person but requires standby guarding of one person either for safety or verbal cueing;
- or score 4 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate independently on a level surface but requires supervision to negotiate (e.g. stairs, inclines, non-flat surfaces);
- be able to participate in therapy and cooperate based on cognitive function;
- signed informed consent.
Exclusion
- More than 1 year has passed since the stroke;
- scores less than or equal to 3 on the Functional Ambulation Categories (FAC) scale;
- patients who were unable to walk independently before the stroke;
- patients treated with botulinum toxin in the lower limb in the last 3 months;
- use of other lower limb advanced technology treatments during the study;
- a person with limited capacity;
- not physically able to bear weight;
- severe aphasia (impairment of understanding or expression that severely impedes communication);
- other condition that precludes the use of C-Mill or Andago:
- severe emotional disturbance;
- mentally incapacitated patient;
- severe contracture or spasticity preventing the patient from being placed in the machine;
- pregnancy;
- skin disease in the area of contact with the straps;
- fever;
- unhealed fracture fracture;
- inability to use the device due to weight and height limitations of the device;
- epilepsy if you have had a seizure within a year;
- severe visual impairment.
Key Trial Info
Start Date :
January 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06497309
Start Date
January 26 2024
End Date
June 1 2026
Last Update
July 11 2024
Active Locations (1)
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1
National Institute for Medical Rehabilitation
Budapest, Pest County, Hungary, 1121