Rehabilitation With Biofeedback for People After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices..
- Who it may be relevant to
- Registry conditions: Rehabilitation, Stroke. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke
Overview
The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.
Detailed description
Study participants will be randomly assigned to a study group and a control group.
* Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device * Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device * Control group - will complete a standard spa rehabilitation program without biofeedback exercises.
The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke.
Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit.
Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence.
Measurements will be performed three times for all participants:
* hand muscle strength assessment * calculated body mass index (BMI) * proprioceptive testing (mirror test, Thumb Location Test) * rehabilitation outcome assessment * functional capacity - Barthel Index, ADL * Ashworth muscle tone (spasticity) * hand dexterity using the Box and Blocks test * hand grip function according to the Frenchay scale * motor function of the hand and upper limb according to the Fugl-Meyer Motor Assessment Scale for Upper Extremity
Interventions
- Other Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Patients in study groups I and II will also receive 30 minutes daily of hand biofeedback training using the Biometrics E-link device (group I) and hand biofeedback training using the Stella Bio device (group II).
Primary outcome measures
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Time frame: First examination - before the start of the rehabilitation program]
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Time frame: Second examination - at the end of the three-week program]
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit]
Secondary outcome measures (12)
- Hand grip strength [Time frame: First examination - before the start of the rehabilitation program]
- Hand grip strength [Time frame: Second examination - at the end of the three-week program]
- Hand grip strength [Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit]
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Time frame: First examination - before the start of the rehabilitation program]
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Time frame: Second examination - at the end of the three-week program]
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit]
- Manual skills, assessed with Box and Blocks test; [Time frame: First examination - before the start of the rehabilitation program]
- Manual skills, assessed with Box and Blocks test; [Time frame: Second examination - at the end of the three-week program]
- Manual skills, assessed with Box and Blocks test; [Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit]
- Assessment of proprioception Thumb Localizing Test (TLT) [Time frame: First examination - before the start of the rehabilitation program]
- Assessment of proprioception Thumb Localizing Test (TLT) [Time frame: Second examination - at the end of the three-week program]
- Assessment of proprioception Thumb Localizing Test (TLT) [Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit]
Eligibility criteria
Inclusion criteria
- informed, voluntary consent of the patient
- age 45-80 years
- elementary (basic) gripping ability
- degree of paresis of the upper limb and hand 4 -5 on the Brunnström scale
- degree of disability on the Rankin scale 3
- spastic tension of the upper limb, paresis hand not more than 3 on the modified Ashworth scale - current health condition confirmed by a medical examination, allowing participation in tests and exercises
Exclusion criteria
- lack of informed, voluntary consent of the patient
- second or subsequent stroke, hemorrhagic stroke, stroke of the brainstem and cerebellum
- disorders of higher mental functions limiting comprehension and carrying out tasks during exercises
- visual field disturbances
- mechanical and thermal injuries that may limit the grasping function of the hand
- concomitant neurological, rheumatological and orthopedic diseases, including permanent - contractures that may affect the grasping ability and locomotion
- unstable medical condition
- failure to complete a 3-week rehabilitation stay
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- University of Rzeszów — Rzeszów
Identifiers
NCT: NCT07333079 · Stroke rehabilitation