Rehabilitation of Arm Function Using a Biofeedback Method After Stroke
Condition: Rehabilitation; Stroke; Biofeedback
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The research will make it possible to assess effects of rehabilitation of arm function with
      the use of biofeedback method and conventional therapies administered to patients at a
      chronic stage of recovery post-stroke, as part of the treatment in a health-resort setting.
    

Detailed description: 
      : In accordance with the study design, the group will comprise 100 patients with hemiparesis
      after stroke, participating in a health-resort based rehabilitation program during their stay
      in the Health-Resort Rehabilitation Hospital in Iwonicz Zdrój, Poland. The minimum size of
      the sample was calculated based on the total annual number of patients after stroke receiving
      treatment in the Health-Resort Rehabilitation Hospital in Iwonicz Zdrój, i.e. approximately
      200 patients, 100% of these being in a chronic stage of recovery. It was assumed that 50% of
      the patients would present stage 4-5 arm paresis according Brunnström scale. A fraction of
      0.8 and a maximum error of 5% were applied and the sample size of 71 patients was obtained.

      The patients meeting eligibility criteria will be randomly divided into two groups:

        -  the study group (50 patients), participating in a conventional rehabilitation program
           supplemented with additional biofeedback training;

        -  the control group (50 patients), participating in the conventional rehabilitation
           program only.

      The patients in both groups will participate in a three-week rehabilitation program (from
      Monday to Friday), with the treatments and therapies continued for up to two hours per day.
      The program will include: group and individual exercise (active and assisted exercises,
      manipulation exercises, PNF-based practice, balance and breathing exercises), manual massage,
      physical treatments, such as: laser, whirlpool therapy, mud compress therapy, carbonic acid
      therapy, TENS therapy, BIO-V lamp, and localized cryotherapy. The patients in the study group
      will also receive biofeedback training aimed to improve motor function of the upper limb. The
      exercise will be performed using equipment manufactured by Biometrics. The device makes it
      possible to perform movements in all the planes of the joints in the upper limb. During the
      exercise, a visualisation of the movements is shown to the patient on the screen; this
      biofeedback makes it possible for them to regulate and increase the range of movement, to use
      greater muscle strength and to visually assess the accuracy of their performance. The
      training with the biofeedback function will be carried out for 30 minutes per day.

      After the program is completed, the subjects from the control group will have an opportunity
      to also practice with the Biometrics device with the biofeedback function.

      Examinations will be carried out three times: the baseline at the start of the rehabilitation
      program, a check-up at the end of the three-week program, and a follow-up two months after
      discharge from the hospital. The tests will be performed at the same time of day, and
      following the same conditions.

      The patients' condition and the rehabilitation effects will be assessed using the following
      measures:

        -  hand grip strength and pinching strength of the fingers, to be tested with a dynamometer
           and pinch meter, respectively;

        -  ranges of motion in the joints of the upper limb, with R500 goniometer;

        -  manual skills, with Box and Blocks test;

        -  handgrip function, according Franchay scale;

        -  motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale;

        -  EMG test, with the Biometrics device;

        -  activities of daily living, with Barthel Index.
    

Intervention name(s): Biofeedback method; Health-resort based rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Patients in the study group will participate in training with visual biofeedback, aimed to improve motor function of the arm. The exercise will be performed using a Biometrics device. The biofeedback training will be carried out for 30 minutes per day.
Health-resort based rehabilitation The patients will participate in a three-week rehabilitation program (from Monday to Friday), with the treatments and therapies continued for up to two hours per day.
The program will include: group and individual exercise (active and assisted exercises, manipulation exercise, PNF-based practice, balance and breathing exercise), manual massage, physical treatments, such as: laser, whirlpool therapy, mud compress therapy, carbonic acid therapy, TENS therapy, BIO-V lamp, and localized cryotherapy.; The patients will participate in a three-week rehabilitation program (from Monday to Friday), with the treatments and therapies continued for up to two hours per day.
The program will include: group and individual exercise (active and assisted exercises, manipulation exercise, PNF-based practice, balance and breathing exercise), manual massage, physical treatments, such as: laser, whirlpool therapy, mud compress therapy, carbonic acid therapy, TENS therapy, BIO-V lamp, and localized cryotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: random selection to two groups (study group and control group)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Health-resort based rehabilitation; Stroke; Biofeedback; Conventional (traditional) rehabilitation