Clinical trial NCT05182411: Validity and Reliability of Turkish Version Leg Activity Measure
Official title: Validity and Reliability of Turkish Version Leg Activity Measure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Multiple Sclerosis
Stroke
Keywords: activity
participation
spasticity
passive function
active function
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult neurological patients with spasticity of the lower extremities

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Turkish version of Leg Activity Measure
timeFrame: First day
measure: Turkish version of Leg Activity Measure
timeFrame: 2 weeks later
Secondary outcomes:
measure: The Rivermead Mobility Index
timeFrame: First day
measure: Nottingham Health Profile (NHP)
timeFrame: First day
measure: The Functional Independence Measure (FIM)
timeFrame: First day
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Zekiye İpek Katırcı Kırmacı
role: PRINCIPAL_INVESTIGATOR
References: