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Completed

NCT Number: 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.

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Key information

Conditions

Spinal Cord Injuries Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Multiple Sclerosis Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment

Other

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

Primary outcomes

  1. Turkish version of Leg Activity Measure

    Time frame: 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.

  2. Turkish version of Leg Activity Measure

    Time frame: 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.

Secondary outcomes

  1. The Rivermead Mobility Index

    Time frame: First day

    The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run

  2. Nottingham Health Profile (NHP)

    Time frame: 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

  3. The Functional Independence Measure (FIM)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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