Rehabilitation With Biofeedback for People After Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorUniversity of Rzeszow

About this trial

The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.

    Other intervention

    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).

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Group I-Biofeedback method using the Biometrics E-link device and Health-resort based rehabilitationExperimental treatment 1 intervention
Group B: Group II -Biofeedback method using the Stella Bio device and Health-resort based rehabilitation.Experimental treatment 1 intervention
Group C: Health-resort based rehabilitation.No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

Time frame
First examination - before the start of the rehabilitation program
2

Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

Time frame
Second examination - at the end of the three-week program
3

Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

Time frame
Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

Secondary outcomes

1

Hand grip strength

measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

Time frame
First examination - before the start of the rehabilitation program
2

Hand grip strength

measurements to be performed with a dynamometer The dynamometer registers strength

Time frame
Second examination - at the end of the three-week program
3

Hand grip strength

measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

Time frame
Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
4

Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.

Activities of daily living were assessed using Barthel Index. The subjects could score the maximum of 100 points. A maximum of 100 points can be obtained on the Barthel scale. There are three assessment ranges: getting from 0 to 20 points. means total dependence, from 20 to 80 points. means that to some extent the patient needs help from others, and the assessment in the border is 80 to 100 points. means that with a little help the patient can function alone. 0-20 points patient's condition "light" 21-85 points - "medium-heavy" patient condition 86-100 points - patient condition "very heavy"

Time frame
First examination - before the start of the rehabilitation program

Other outcomes

1

Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.

Increased muscle tone (spasticity) was examined with modified Ashworth scale. This is a six-point scale modified to include grade 1. 0: No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension \[Time Frame: First examination - before the start of the rehabilitation program\]

Time frame
First examination - before the start of the rehabilitation program
2

Assessment of disability level, using the modified Rankin scale (MRS)

Assessment of disability using the modified Rankin scale (MRS) Score Description 0 - No symptoms at all 1- No significant disability despite symptoms; able to carry out all usual duties and activities 2 - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 - Moderate disability; requiring some help, but able to walk without assistance 4 - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 - Dead TOTAL (0-6):

Time frame
First examination - before the start of the rehabilitation program
3

Assessment of paretic limb function was assessed using the Brunnström scale

Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities

Time frame
First examination - before the start of the rehabilitation program
4

Body mass index (BMI)

WHO BMI classification for adults: \< 18.5 - Underweight (including: \<16.0 starvation, 16.0-16.9 emaciation, 17.0-18.4 underweight) 18.5-24.9 - Normal body weight 25.0-29.9 - Overweight 30.0-34.9 - Class I obesity 35.0-39.9 - Class II obesity (clinical obesity) ≥ 40.0 - Class III obesity (extreme obesity)

Time frame
First examination - before the start of the rehabilitation program

Sponsors and contacts

Click on the lead sponsor to view all of their trials.