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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05182411
Other study ID # ipekkkirmaci
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2022
Est. completion date August 5, 2022

Study information

Verified date August 2022
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 5, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
assessment
Turkish version of Leg Activity Measure Rivearmead Mobility Index Nottingham Health Profile Functional Independence Measures

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Turkish version of Leg Activity Measure 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
Primary Turkish version of Leg Activity Measure 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
Secondary The Rivermead Mobility Index The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run First day
Secondary Nottingham Health Profile (NHP) 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
Secondary The Functional Independence Measure (FIM) 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
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