NCT04777253

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

February 11, 2021

Last Update Submit

March 30, 2022

Conditions

RehabilitationStrokeBiofeedback

Keywords

Health-resort based rehabilitationStrokeBiofeedbackConventional (traditional) rehabilitation

Outcome Measures

Primary Outcomes (12)

  • Hand grip strength

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

    : 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,

    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,

    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.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    Third examination - two months after discharge from the hospital (follow- up)

Secondary Outcomes (7)

  • Activities of daily living, assessed with Barthel Index.

    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;

    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

    : 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

    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.

    Measurement during the patient's enrolment

  • +2 more secondary outcomes

Study Arms (2)

Biofeedback method and Health-resort based rehabilitation

EXPERIMENTAL

Health-resort based treatments supplemented with biofeedback training

Other: Biofeedback methodOther: Health-resort based rehabilitation

Health-resort based rehabilitation

OTHER

Control group - health-resort based treatments, without biofeedback training.

Other: Health-resort based rehabilitation

Interventions

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.

Biofeedback method and Health-resort based rehabilitation
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

Biofeedback method and Health-resort based rehabilitationHealth-resort based rehabilitation

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rzeszów

Rzeszów, 35-959, Poland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bogumiła Pniak, MSc

    University of Rzeszow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: random selection to two groups (study group and control group)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 11, 2021

First Posted

March 2, 2021

Study Start

April 1, 2021

Primary Completion

November 2, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

PL(1)