Assessment of Functional Efficiency of the Upper Limb After Stroke

NCT06675487 | Completed

• 1 other identifier: 035/06/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Stroke; Ischemic; Rehabilitation; functional efficiency

Outcome Measures

Primary Outcomes (4)

• The Motor Activity Log (MAL)

  The Motor Activity Log (MAL) - a subjective scale, consisting in assessing the quantity and quality of movements of the directly affected limb, outside laboratory conditions. Participants of the study answer 30 standardized questions about the amount of movement (Amount Scale or AS) and quality of movement (How Well Scale or HW) in the directly affected limb. The scales are located on separately printed forms, the subjects are informed about the method of assessment, as well as the possibility of entering half-grades (e.g. 0.5, 4.5). Where 0 means that there is no possibility of movement and 5 means that the arm movement is possible.

  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)

• Rasch-Based MAL-18

  Rasch-Based MAL-18 - is a shortened version of MAL-28, the examined person answers questions about 18 actions (from simple to alternative, leading actions) and advises them in the following way: 0 points - ends not used 0 points - movement is in a very small size 0 points - movement ends with paralysis requires dependent assistance 1 point - movement ends in a height encompassing 2 points - movement almost within the norm 3 points - movement within the norm.

  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)

• The Chedoke Arm and Hand Activity Inventory (CAHAI)

  Is used to assess upper limb function, consists of 13 activities that the examined person has to perform. Activity Scale: 1. total assist (weak U/L \< 25%) 2. maximal assist (weak U/L = 25-49%) 3. moderate assist (weak U/L = 50-74%) 4. minimal assist (weak U/L \> 75%) 5. supervision 6. modified independence (device) 7. complete independence (timely, safely)

  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)

• D u r u ö z H a n d I n d e x ( D H I )

  18 questions regarding ability to carry out manual tasks. Questions are grouped in five domains: In the kitchen (8), dressing (2), hygiene (2), in the office (2), and other (4) The patient is instructed to answer each question in terms of the level of difficulty they experience completing various tasks without help from another person or assistive device (Sezer, Yavzer, Sivrioglu, Basaran, \& Koseoglue, 2006) Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The 18 individual scores are summed to obtain a composite score The total score ranges from 0-90 with higher scores indicating poorer hand functioning

  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 (17)

• Barthel scale

  First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program

• VAS scale

  First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program

• WHOQOL-BREF

  First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program

• Stroke Quality of Life Scale - (SSQOL)

  First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program

• Box and Blocks test

  First measurement before rehabilitation treatment, second after 3 weeks of rehabilitation program

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-310, Poland

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Krzysztof Bylicki

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 6, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

PL (1)