RehabilitationNCT04777253
Rehabilitation of Arm Function Using a Biofeedback Method After Stroke
A study testing Biofeedback method and Health-resort based rehabilitation in people with Rehabilitation and Stroke, run by Bogumiła Pniak at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Rehabilitation, Stroke, Biofeedback
- What is being tested?
- Biofeedback method and Health-resort based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed, voluntary consent of the patient;
- a single ischemic stroke experienced;
- hemiparesis;
- a minimum of 6 months from the stroke onset;
- age 45-75 years;
- elementary (basic) handgrip ability;
Show all 10Show fewer
- stage 4-5 arm paresis according Brunnström scale;
- stage 3 disability according to Rankin scale;
- spasticity in the paretic arm up to 1 plus on the modified Ashworth scale;
- current health status, confirmed by a medical examination, allowing the person to take part in the study and in the exercise.
Who cannot join
- lack of informed and voluntary consent of the patient;
- two or more strokes experienced, haemorrhagic stroke, brain stem and cerebellar stroke;
- impairments in higher mental functions adversely affecting the ability to understand and perform the tasks during exercise;
- visual field impairment;
- mechanical and thermal injuries potentially limiting handgrip function;
- coexisting neurological, rheumatic and orthopaedic conditions, including fixed contractures potentially affecting gripping abilities;
- unstable health condition;
- failure to complete the three-week rehabilitation program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Biofeedback Methods in Rehabilitation of Arm Function in Patients After Stroke
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.
Read the 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.
- Conditions
- Rehabilitation, Stroke, Biofeedback
- Being tested
- Biofeedback method, Health-resort based rehabilitation
- Keywords
- Health-resort based rehabilitation, Stroke, Biofeedback, Conventional (traditional) rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback methodOther
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.
Health-resort based rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback method and Health-resort based rehabilitation | Experimental | Health-resort based treatments supplemented with biofeedback training Receives: Other: Biofeedback method; Other: Health-resort based rehabilitation |
| Health-resort based rehabilitation | Other | Control group - health-resort based treatments, without biofeedback training. Receives: Other: Health-resort based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
Measured: : First examination - before the start of the rehabilitation program;
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
Measured: Second examination - at the end of the three-week program
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
Measured: Third examination - two months after discharge from the hospital (follow- up)
pinching strength of the fingers
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
Measured: First examination - before the start of the rehabilitation program
pinching strength of the fingers
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
Measured: Second examination - at the end of the three-week program
pinching strength of the fingers
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
Measured: Third examination - two months after discharge from the hospital (follow- up)
Ranges of motion in the joints of the upper limb
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Measured: First examination - before the start of the rehabilitation program
Ranges of motion in the joints of the upper limb
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Measured: Second examination - at the end of the three-week program
Ranges of motion in the joints of the upper limb
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Measured: Third examination - two months after discharge from the hospital (follow- up)
EMG of extensors and flexors of the radiocarpal joint
EMG assessment of extensors and flexors of the radiocarpal joint on the Biometrics device
Measured: First examination - before the start of the rehabilitation program
EMG of extensors and flexors of the radiocarpal joint
EMG assessment of extensors and flexors of the radiocarpal joint on the Biometrics device
Measured: Second examination - at the end of the three-week program
EMG of extensors and flexors of the radiocarpal joint
EMG assessment of extensors and flexors of the radiocarpal joint on the Biometrics device
Measured: Third examination - two months after discharge from the hospital (follow- up)
Secondary outcomes (7)
Activities of daily living, assessed with Barthel Index.
Based on the scores assigned the patient's condition is described in the following way: I. 86-100 points - "slight" dependency; II. 21- 85 points - "moderately severe" dependency; III. 0 - 20 points - "severe" dependency.
A maximum 100 points can be scored on Barthel scale.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Manual skills, assessed with Box and Blocks test;
The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Handgrip function, according Franchay scale
The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills.
Measured: : First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
Fugl-Meyer Motor Assessment Scale for Upper Extremity is a comprehensive tool enabling measurement of motor function; it comprises 33 motor tasks, designed to assess general movements, precision movements, grip, coordination and speed. It is also possible to perform H subgroup tests - assessing superficial and deep sensibility, and J subgroup tests - for range of passive motion and pain induced by such movements.
Individual tasks are assessed on a scale 0-2 0 - impossible task
- - task partially completed,
- - task completed correctly The higher the score, the better.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Assessment of paretic limb function with the Brunnström scale.
Motor performance (function) of extremities is to be assessed using Brunnström scale. This is a six-point scale designed to evaluate performance (function) of paretic extremities.The higher the score, the better.
1-No moves 6-Precise movements, ball throw, button fastening and unfastening
Measured: Measurement during the patient's enrolment
Muscle tone (spasticity) will be examined with modified Ashworth scale.
Increased muscle tone (spasticity) is to be 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 moped;
- Considerable increase in muscle tone, passive movement difficult;
- Affected part(s) rigid in flexion or extension.
Measured: Measurement during the patient's enrolment
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):
Measured: : Measurement during the patient's enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Apr 2021
- Primary completion2 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random selection to two groups (study group and control group)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogumiła Pniak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bogumiła Pniak, University of Rzeszow
- Investigators
- Bogumiła Pniak, MSc, Principal investigator, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777253
- Sponsor's protocol ID
- stroke - biofeedback
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Biofeedback Methods in Rehabilitation of Arm Function in Patients After Stroke
- ClinicalTrials.gov ID
- NCT04777253
- Acronym / sponsor ID
- stroke - biofeedback
- Conditions
- Rehabilitation, Stroke, Biofeedback
- Keywords
- Health-resort based rehabilitation, Stroke, Biofeedback, Conventional (traditional) rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bogumiła PniakUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- random selection to two groups (study group and control group)
| Arm | Type | Receives |
|---|---|---|
| Biofeedback method and Health-resort based rehabilitation | Experimental | Other: Biofeedback method, Other: Health-resort based rehabilitationHealth-resort based treatments supplemented with biofeedback training |
| Health-resort based rehabilitation | Other | Other: Health-resort based rehabilitationControl group - health-resort based treatments, without biofeedback training. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- informed, voluntary consent of the patient;
- a single ischemic stroke experienced;
- hemiparesis;
- a minimum of 6 months from the stroke onset;
- age 45-75 years;
Key exclusion criteria (8 listed)
- lack of informed and voluntary consent of the patient;
- two or more strokes experienced, haemorrhagic stroke, brain stem and cerebellar stroke;
- impairments in higher mental functions adversely affecting the ability to understand and perform the tasks during exercise;
- visual field impairment;
- mechanical and thermal injuries potentially limiting handgrip function;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback methodPatients 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. | Other | Biofeedback method and Health-resort based rehabilitation |
| Health-resort based rehabilitationThe 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 | Other | Biofeedback method and Health-resort based rehabilitation, Health-resort based rehabilitation |
Primary outcome
Hand grip strength
Time frame: : First examination - before the start of the rehabilitation program;
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
Hand grip strength
Time frame: Second examination - at the end of the three-week program
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
Hand grip strength
Time frame: Third examination - two months after discharge from the hospital (follow- up)
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
pinching strength of the fingers
Time frame: First examination - before the start of the rehabilitation program
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
pinching strength of the fingers
Time frame: Second examination - at the end of the three-week program
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
pinching strength of the fingers
Time frame: Third examination - two months after discharge from the hospital (follow- up)
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
Ranges of motion in the joints of the upper limb
Time frame: First examination - before the start of the rehabilitation program
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Ranges of motion in the joints of the upper limb
Time frame: Second examination - at the end of the three-week program
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Ranges of motion in the joints of the upper limb
Time frame: Third examination - two months after discharge from the hospital (follow- up)
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
EMG of extensors and flexors of the radiocarpal joint
Time frame: First examination - before the start of the rehabilitation program
EMG assessment of extensors and flexors of the radiocarpal joint on the Biometrics device
EMG of extensors and flexors of the radiocarpal joint
Time frame: Second examination - at the end of the three-week program
EMG assessment of extensors and flexors of the radiocarpal joint on the Biometrics device
EMG of extensors and flexors of the radiocarpal joint
Time frame: Third examination - two months after discharge from the hospital (follow- up)
EMG assessment of extensors and flexors of the radiocarpal joint on the Biometrics device
7 secondary outcomes
Activities of daily living, assessed with Barthel Index.
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Manual skills, assessed with Box and Blocks test;
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Handgrip function, according Franchay scale
Time frame: : First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program; third examination - two months after discharge from the hospital (follow- up)
Assessment of paretic limb function with the Brunnström scale.
Time frame: Measurement during the patient's enrolment
Muscle tone (spasticity) will be examined with modified Ashworth scale.
Time frame: Measurement during the patient's enrolment
Assessment of disability level, using the modified Rankin scale (MRS)
Time frame: : Measurement during the patient's enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogumiła Pniak, MSc principal investigator
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback method and Health-resort based rehabilitation in people with Rehabilitation and Stroke, run by Bogumiła Pniak at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: : First examination - before the start of the rehabilitation program;). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.