NCT05182411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

December 15, 2021

Last Update Submit

August 29, 2022

Conditions

Spinal Cord InjuriesMultiple SclerosisStroke

Keywords

activityparticipationspasticitypassive functionactive function

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • The Rivermead Mobility Index

    First day

  • Nottingham Health Profile (NHP)

    First day

  • The Functional Independence Measure (FIM)

    First day

Study Arms (1)

Patients with spasticity

adult neurological patients with spasticities in their lower extremities

Other: assessment

Interventions

assessmentOTHER

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

Patients with spasticity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult neurological patients with spasticity of the lower extremities

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years old, over 65 years old
  • History of trauma in the last 1 year
  • Having alcohol and substance abuse
  • Having a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 38695372DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesMultiple SclerosisStrokeMotor ActivityMuscle Spasticity

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular DiseasesBehaviorMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 10, 2022

Study Start

June 30, 2022

Primary Completion

July 30, 2022

Study Completion

August 5, 2022

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations

TU(1)