- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05182411
Validity and Reliability of Turkish Version Leg Activity Measure
Patient-filled scales minimize the burden of data collection for clinicians in a clinical setting.
Therefore, Leg activity measure, a new self-report measure of active and passive function in the leg, has been developed.
Leg activity measure consists of three parts. The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
It is a valid and reliable test in adult neurological patients with lower extremity spasticity. It can be used in the evaluation of the active and passive functions of the results of the clinicians' interventions by making the cultural adaptation of the Turkish language and examining its validity and reliability. We think that it will be important to determine the limitations in activity, participation and daily living activities and to evaluate their reflections.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Spasticity is a common symptom resulting from stroke, brain trauma, and degenerative brain diseases. Spasticity, known as rate-dependent resistance to passive movement, prevents many activities of daily living. Lower extremity spasticity, on the other hand, hinders joint movements and complicates mobility, transfer and passive activities of caregivers.
Goals for the treatment of spasticity often focus on active function improvements in walking, standing, and moving from different sitting positions. However, improvements in passive function tasks and symptom management are often equally important to patients. Active function is the use of the limb to directly perform a task. Passive fonskyion is care of the affected extremity, usually performed by the person himself, but may require assistance from another person.
There is a need for instruments with demonstrable measurement properties that can reflect a clinically significant change in practice. Outcomes developed for treatments such as botulinum toxin and physical interventions for spasticity aimed at improving any aspect of functional performance (active and passive function) should ideally reflect real-life function as opposed to simply observed tasks in the clinical setting.
Leg activity measure filled by the patient consists of three parts. The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
It is a valid and reliable test in adult neurological patients with lower extremity spasticity. It can be used in the evaluation of the active and passive functions of the results of the clinicians' interventions by making the cultural adaptation of the Turkish language and examining its validity and reliability.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Kahramanmaraş, Kalkun
- Kahramanmaras Sutcu Imam University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 1 or more spasticity in at least one muscle according to the Modified Ashworth Scale
- Be between the ages of 18-65
- Volunteering to participate in the study
Exclusion Criteria:
- Under 18 years old, over 65 years old
- History of trauma in the last 1 year
- Having alcohol and substance abuse
- Having a pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Patients with spasticity
adult neurological patients with spasticities in their lower extremities
|
Turkish version of Leg Activity Measure Rivearmead Mobility Index Nottingham Health Profile Functional Independence Measures
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Turkish version of Leg Activity Measure
Tidsramme: First day
|
Leg activity measure consists of three parts.
The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
The questions in each section are scored between 0-4.
An increase in the score indicates that the activity could not be performed.
|
First day
|
Turkish version of Leg Activity Measure
Tidsramme: 2 weeks later
|
Leg activity measure consists of three parts.
The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
The questions in each section are scored between 0-4.
An increase in the score indicates that the activity could not be performed.
|
2 weeks later
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Rivermead Mobility Index
Tidsramme: First day
|
The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run
|
First day
|
Nottingham Health Profile (NHP)
Tidsramme: First day
|
The NHP is a patient-reported questionnaire. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life. The questionnaire is divided into two parts. The first parts comprises 38 questions in six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. The second part of the NHP is made up of seven statements about areas of life that are commonly affected by health: paid employment, jobs around the house, social life, personal relationships, sex life, hobbies and interests, and holidays |
First day
|
The Functional Independence Measure (FIM)
Tidsramme: First day
|
The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. |
First day
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ipekkkirmaci
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med assessment
-
Al-Azhar UniversityRekrutteringCaries i tænderne | Udbrud | BMIEgypten
-
Empatica, Inc.United States Department of DefenseAfsluttet
-
Thomas Jefferson UniversityAfsluttetHæmatopoietisk og lymfoid celle-neoplasma | Ondartet fast neoplasmaForenede Stater
-
Guy's and St Thomas' NHS Foundation TrustMacusoftIkke rekrutterer endnuDiabetisk makulært ødem | Retinal veneokklusion | Våd makuladegenerationDet Forenede Kongerige
-
Texas Woman's UniversityAfsluttetAutismespektrumforstyrrelse
-
University Hospital, LilleAfsluttetKognitivt symptom | Evalueringer, Diagnostisk SelvFrankrig
-
University of OklahomaRekrutteringHoved- og halskræftForenede Stater
-
Alzheimer's Light LLCRekrutteringMultipel sclerose | Parkinsons sygdom | Alzheimers sygdom | Mild kognitiv svækkelse | Frontotemporal demens | Vaskulær demens | TBIForenede Stater
-
Natera, Inc.Trukket tilbageHjertetransplantationssvigt og afvisning
-
Mansoura University HospitalAfsluttetIskæmisk slagtilfælde | Kognitiv svækkelse | Udfald, fataltEgypten