NCT05244850

Brief Summary

Cerebrovascular accident is the third leading cause of death in developed countries after heart disease and cancer. In adults, it ranks first among neurological diseases in terms of causing death and disability. About one-third of stroke patients experience permanent physical dysfunction. This situation has a negative impact on the economic, social, psychological life and general quality of life of the patient and his family. Stroke is one of the leading causes of long-term disability in adults due to problems such as activity limitations and participation restrictions caused by disorders in body functions. Movement disorder is one of the most common symptoms of stroke, and people with stroke often have trouble falling while walking after they are discharged from the hospital. Therefore, one of the main goals of stroke rehabilitation is to regain independent mobility with a safe and stable gait pattern. In addition to all these, one of the problems faced by most stroke patients is sensory-perception disorders. Sensory impairment can be experienced as the inability to perceive the senses or the inability to distinguish the senses. It should be considered that sensory awareness decreases as more than one sensory impulse competes with each other at the same time, and this situation should not be ignored during the evaluation. Although motor movement is governed by the normal motor field, the adjustment of our position in space is entirely the task of the sensory field. It is not possible to initiate and coordinate movement without sensory control. Since environmental change cannot be perceived during movement, it is not possible to provide environmental adaptation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

February 8, 2022

Last Update Submit

February 8, 2022

Conditions

Keywords

trunk controlbalanceLower extremity sense

Outcome Measures

Primary Outcomes (4)

  • Trunk Impairment Scale

    The Trunk Impairment Scale consists of 3 subscales: static sitting balance (3 items), dynamic sitting balance (10 items) and coordination (4 items). The maximum score of the owner is 7, 10 and 6 points respectively. The Total Trunk Impairment Scale score ranges from 0 to 23, with higher scores indicating better trunk control.

    At baseline

  • Tinetti Balance and Gait Test

    It consists of two parts, walking and balance. Consisting of 16 questions in total, the scale consists of 9 questions in which balance is evaluated first, followed by 7 questions in which gait is evaluated. The total score obtained by the evaluated participant from the first 9 questions constitutes the balance score, and the total score obtained from the following 7 questions constitutes the walking score. 2 points means that the requested task was done correctly, 1 point means that the task was done with adaptations, and 0 points means that the desired task could not be done. A total test score of 18 or less indicates a high fall risk, a moderate fall risk of 19-24 points, and a low-level fall risk with a score above 24.

    At baseline

  • Ten Meter Walking Test

    During the test, the patient walks at a normal walking pace for a distance of 10 meters and the time is recorded.

    At baseline

  • Fugl Mayer Assesment of Sensorimotor Function

    The sensory subscale of FMA (FMA-S) consists of 12 sub-parameters; 4 items are for light touch and 8 items are for proprioception sense. Scoring is between 0-24 points. The light touch sensation is subjectively tested. Joint position is tested on the thumb, wrist, elbow, and interphalangeal joint of the glenohumeral joint. Position sense of the lower extremities is tested on the toe, ankle, knee and hip joint.

    At baseline

Secondary Outcomes (1)

  • Turkish version of Postural Assessment Scale for Stroke Patients (PASS-T)

    At baseline

Study Arms (1)

One group

Stroke patients

Other: Test

Interventions

TestOTHER

Measurements

One group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke Patients

You may qualify if:

  • Able to walk 10 m without physical assistance,
  • Lower extremity functions are in stages 2-6 according to Brunnstrom motor recovery stages,
  • At least 3 days and at most 24 months have passed since the stroke,
  • Stroke individuals with a score of 7 or higher on the Hodkinson Mental score

You may not qualify if:

  • Having neurological and orthopedic problems that may affect walking other than stroke,
  • Having a history of cardiovascular and rheumatological diseases that prevent daily activities,
  • Lesion or fracture in the lower extremity,
  • Lower extremity spasticity 4 according to the modified Ashworth Scale,
  • Individuals with aphasia and communication disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

January 15, 2021

Primary Completion

June 1, 2021

Study Completion

June 15, 2021

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations