Spinal Cord InjuriesNCT05182411
Validity and Reliability of Turkish Version Leg Activity Measure
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
- What is being tested?
- assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2022to 5 Aug 2022
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult neurological patients with spasticity of the lower extremities
Who may be able to join
- 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
Who cannot join
- Under 18 years old, over 65 years old
- History of trauma in the last 1 year
- Having alcohol and substance abuse
- Having a pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sutcu Imam University
Kahramanmaraş
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
- Being tested
- assessment
- Keywords
- activity, participation, spasticity, passive function, active function
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Stroke, Motor Activity, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
Turkish version of Leg Activity Measure Rivearmead Mobility Index Nottingham Health Profile Functional Independence Measures
| Study group | Role | What they receive |
|---|---|---|
| Patients with spasticity | adult neurological patients with spasticities in their lower extremities Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day
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.
Measured: 2 weeks later
Secondary outcomes (3)
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
Measured: First day
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
Measured: First day
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.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start30 Jun 2022
- Primary completion30 Jul 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182411
- Sponsor's protocol ID
- ipekkkirmaci
- Status last verified
- Aug 2022
- First submitted
- 15 Dec 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kirmaci ZIK, Adiguzel H, Kirmaci YS, Tasvuran Horata E, Tuncel Berktas D, Erel S. Turkish translation and transcultural validity and reliability of an assessment tool for spasticity: Leg Activity Measure (Leg A). Neurol Res. 2024 Jul;46(7):644-652. doi: 10.1080/01616412.2024.2340878. Epub 2024 May 2.
PubMed 38695372
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Turkish Version Leg Activity Measure
- ClinicalTrials.gov ID
- NCT05182411
- Acronym / sponsor ID
- ipekkkirmaci
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
- Keywords
- activity, participation, spasticity, passive function, active function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with spasticity | – | Other: assessmentadult neurological patients with spasticities in their lower extremities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult neurological patients with spasticity of the lower extremities
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Under 18 years old, over 65 years old
- History of trauma in the last 1 year
- Having alcohol and substance abuse
- Having a pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentTurkish version of Leg Activity Measure Rivearmead Mobility Index Nottingham Health Profile Functional Independence Measures | Other | Patients with spasticity |
Primary outcome
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.
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.
3 secondary outcomes
The Rivermead Mobility Index
Time frame: First day
Nottingham Health Profile (NHP)
Time frame: First day
The Functional Independence Measure (FIM)
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 38695372Kirmaci ZIK, Adiguzel H, Kirmaci YS, Tasvuran Horata E, Tuncel Berktas D, Erel S. Turkish translation and transcultural validity and reliability of an assessment tool for spasticity: Leg Activity Measure (Leg A). Neurol Res. 2024 Jul;46(7):644-652. doi: 10.1080/01616412.2024.2340878. Epub 2024 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish version of Leg Activity Measure (time frame: First day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05182411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.