Clinical trial NCT06675487: Assessment of Functional Efficiency of the Upper Limb After Stroke
Official title: Polish Adaptation and Validation of Questionnaires for Assessing the Functional Efficiency of the Upper Limb After Stroke.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Ischemic
Keywords: Stroke
Ischemic
Rehabilitation
functional efficiency
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The planned group size is 100 patients with hemiparesis after stroke staying on a rehabilitation stay at the Excelsior Spa and Rehabilitation Hospital in Iwonicz Zdrój.

Brief summary: The aim of the study will be to: conduct the process of cultural and linguistic adaptation of questionnaires for assessing the functional efficiency of the upper limb to the Polish version and to assess psychometric properties: reliability, validity and sensitivity to clinical changes among patients after stroke.

Detailed description: Conducting the process of cultural and linguistic adaptation of questionnaires to the Polish version and assessing psychometric properties: reliability, validity and sensitivity to clinical changes of questionnaires for assessing the functional efficiency of the upper limb among patients after stroke. The following questionnaires will be used:

* The Motor Activity Log (MAL) Rasch-Based MAL-18
* The Chedoke Arm and Hand Activity Inventory (CAHAI) -- D u r u ö z H a n d I n d e x ( D H I ) Internal and external consistency between questions (whether they are used to assess the same phenomenon/function) and studies will be conducted twice (first time, and then after 2 weeks by three researchers under the same conditions.

To assess the validity and sensitivity of the tools, patients will be additionally assessed:

* Barthel scale
* VAS scale
* WHOQOL-BREF questionnaire for assessing quality of life
* Stroke Quality of Life Scale - (SSQOL).
* Functional electrostimulation and EMG
* The Modified Ashworth Scale (MAS)
* Box and Blocks
* Franchay scale
* Fugl-Meyer Motor Assessment Scale for Upper Extremity
* measurement using a dynamometer and pinchmeter
* measurement using the R500 goniometer

After assessing the reliability and validity of the tools, the sensitivity will be assessed based on the assessment of the effects of rehabilitation in people after a stroke before the start of the stay and after the 3-week rehabilitation program.

Procedure for testing the sensitivity of the research tools:

The subjects will participate in a 3-week rehabilitation program from Monday to Friday, 15 days in the stay. Each patient staying at the spa hospital participated in a comprehensive rehabilitation program conducted during the day, lasting from 120 to 150 minutes.

The program will include: group and individual exercises (active, assisted, manipulation exercises, exercises using the PNF method, balance exercises, breathing exercises), manual massage, physical treatments such as: laser, whirlpool bath, mud compresses, carbon dioxide bath, tens currents, bio-v lamp, local cryotherapy, training with biofeedback aimed at improving the motor function of the hand. A Biometrics device will be used for the exercises. The device allows for movements in all planes of individual hand joints. During the exercises, the patient has a visualization of the movements he performs on the monitor screen, thanks to which he can influence the increase in the range of movement and engage greater muscle strength through biofeedback, additionally, the confirmation of correct performance of the task is a visual assessment. The duration of the exercises with the biofeedback function will be 30 minutes a day. Additionally, anthropometric measurements will be performed among the patients.

Body weight will be measured to the nearest 0.1 kg. The content of adipose tissue (FAT), lean tissue (FFM), muscle tissue (PMM), bone tissue (BM) and water (TBW) will be analyzed. Body mass components will be assessed on a Tanita MC 780 MA body composition analyzer using the bioelectrical impedance method (BIA).

Body height will be measured to the nearest 0.1 cm using a portable PORTSTAND 210 stadiometer. Measurements will be performed under standard conditions. For the study, each participant will stand upright under the supervision of the research team and with bare feet.

Body mass index (BMI) will be calculated by dividing the body mass (kg) of each individual by their body height squared (m2). After obtaining the results regarding height and weight, the body mass index (BMI) will be calculated, and then the BMI value will be related to the obesity classification according to the WHO: ≤ 18.49 underweight, 18.5 - 24.99 normal body weight, 25 - 29.99 overweight, ≥ 30 obesity.

The research will be conducted at the Spa and Rehabilitation Hospital in Iwonicz Zdrój. After meeting the inclusion criteria, qualification for the study will be performed. The internal and external reliability of the tools will be assessed twice (first time and then after 2 weeks by three researchers in the same conditions). Then the accuracy of the selection of tools will be assessed based on the selected scales, questionnaires.

After assessing the reliability and validity of the tools, sensitivity will be assessed based on the assessment of rehabilitation effects in people after stroke before the start of the stay and after the 3-week rehabilitation program. The study is planned to be conducted in the morning hours. The study time for one participant will be 60 minutes.

Eligibility criteria: Inclusion Criteria:

* informed, voluntary consent of the patient
* completed, single ischemic stroke
* hemiparesis
* time since stroke at least 6 months
* age 45-75 years
* elementary (basic) grip ability
* degree of paresis of the upper limb, hand and lower limb 4-5 on the Brunnström scale
* degree of disability on the Rankin scale 3
* spastic tone of the paretic upper limb, hand and lower limb no more than 1 plus on the modified Ashworth scale - current health condition confirmed by a medical examination allowing participation in the tests and exercises

Exclusion Criteria:

* lack of informed, voluntary consent of the patient

  * second or subsequent stroke, hemorrhagic stroke, stroke of the brain stem and cerebellum
  * disorders of higher mental functions limiting understanding and carrying out tasks during exercises
  * visual field disorders
  * mechanical and thermal injuries that may affect the limitation of the grip function of the hand
  * coexisting neurological, rheumatological, orthopedic diseases, including fixed contractures that may affect the grip ability and locomotion
  * unstable medical condition
* metal implants, electronic implants, menstruation in women, epilepsy,
* failure to complete a 3-week rehabilitation stay

Primary outcomes:
measure: The Motor Activity Log (MAL)
timeFrame: Internal and external reliability of the tools: assessed twice (first time and then after 2 weeks). After assessing the reliability and validity of the tools, sensitivity will be assessed (before the start of the stay and after 3 weeks of rehabilitation)
measure: Rasch-Based MAL-18
timeFrame: Internal and external reliability of the tools: assessed twice (first time and then after 2 weeks). After assessing the reliability and validity of the tools, sensitivity will be assessed (before the start of the stay and after 3 weeks of rehabilitation)
measure: The Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: Internal and external reliability of the tools: assessed twice (first time and then after 2 weeks). After assessing the reliability and validity of the tools, sensitivity will be assessed (before the start of the stay and after 3 weeks of rehabilitation)
measure: D u r u ö z H a n d I n d e x ( D H I )
timeFrame: Internal and external reliability of the tools: assessed twice (first time and then after 2 weeks). After assessing the reliability and validity of the tools, sensitivity will be assessed (before the start of the stay and after 3 weeks of rehabilitation)
Secondary outcomes:
measure: Barthel scale
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: VAS scale
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: WHOQOL-BREF
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Stroke Quality of Life Scale - (SSQOL)
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Box and Blocks test
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Franchay scale
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Fugl-Meyer Assessment (FMA)
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Hand grip strength
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Pinching strength of the fingers
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Functional electrostimulation and EMG
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Body height
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Body weight
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: Body mass index (BMI)
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
measure: The Modified Ashworth Scale (MAS)
timeFrame: Measurement during the patient's enrolment
measure: Assessment of paretic limb function with the Brunnström scale.
timeFrame: Measurement during the patient's enrolment
measure: Assessment of disability level, using the modified Rankin scale (MRS)
timeFrame: Measurement during the patient's enrolment
measure: Range of motion of the joints of the upper limbs
timeFrame: First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
Study officials:
affiliation: University of Rzeszow
name: Krzysztof Bylicki
role: PRINCIPAL_INVESTIGATOR
References: