Reference Values and Determinants of 6-minute Walk Test

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06646003
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief Summary

The first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke.

Detailed Description

There may be large variations in the distance of 6MWT according to the stroke severity. Investigation of factors related to 6MWT may be helpful in determining and targeting appropriate strategies for gait rehabilitation. Accordingly, the first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Submitted: 2024-10-20
• Last Update Posted: 2024-10-22
• Study Start: 2024-10-30
• Primary Completion: 2025-03-05
• Study Completion: 2025-03-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

1. Having first ever stroke
2. The time elapsed after the stroke is more than 6 months and less than 10 years
3. 18-80 years old
4. Those who could walk independently with no assistance or device and who could walk with an intermittent or continuous light touch to assist balance or coordination

Exclusion Criteria

Exclusion Criteria:

1. A history of severe musculoskeletal, cardiopulmonary, or psychiatric disease that can inhibit measurements
2. Patients who had received a neurologic diagnosis other than stroke, such as Parkinson's disease or multiple sclerosis
3. Patients with impaired level of consciousness and evidence of gross cognitive impairment (Scored below 10 points in the Mini-Mental State Examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-minute walk test (6MWT)	through study completion, an average of one month	6MWT will be used to evaluate the walking endurance. A 30-m indoor walkway will be used to conduct the test. The maximal distance covered at the end of the 6MWT will be recorded.

Secondary Outcome Measures

Name	Time	Method
Functional ambulation scale (FAC)	through study completion, an average of one month	Patients will be classified by walking ability using FAC has six levels (0 to 5) that are classified according to the walking ability on the basis of the amount of physical support required, which are as follows: nonfunctional ambulatory(FAC 0); ambulatory, continuous manual contact to support body weight as well as to maintain balance or to assist coordination (FAC 1); ambulatory \[level I\], intermittent or continuous light touch to assist balance or coordination (FAC 2); ambulatory, dependent on supervision (FAC 3); ambulatory, independent, level surface only (FAC 4); and ambulatory, independent (FAC 5).
Brunnstrom motor recovery staging	through study completion, an average of one month	Upper extremity, hand and lower extremity motor recovery will be assessed using the Brunnstrom 6 sequential stages of motor recovery.
Modified Ashworth Scale (MAS)	through study completion, an average of one month	The Modified Ashworth Scale will be used to measure the severity of knee extensor, knee flexor and ankle plantar flexor spasticity. MAS scores will be added together to give a total MAS score. MAS is graded from 0 to 4. A score of 0 indicates no increase at all in muscle tone, and 4 indicates that the joint is rigid in flexion or extension.
Beck depression inventory (BDI)	through study completion, an average of one month	The beck depression inventory (BDI) will be used to evaluate depression. The BDI consists of 21 questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answers, ranging in intensity. A value of 0-3 is assigned for each answer, and the total score is compared with a key to determine the severity of depression .The standard cut off values are as follows: 0-9, minimal depression; 10-18, mild depression; 19-29, moderate depression; and 30-63, severe depression.
Mini-mental state examination (MMSE)	through study completion, an average of one month	The mini-mental state examination will be used to describe mental and cognitive functions.
Star cancellation test	through study completion, an average of one month	Star cancellation test will be used to describe neglect phenomenon.
Barthel Index	through study completion, an average of one month	Activities of daily living (ADL) will be assessed using the Barthel Index. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically ADL and mobility. The items include feeding, bathing, grooming, dressing, toileting, transferring, walking on a level surface, going up and down stairs, and continence of bowel and bladder. A patient with a maximum score of 100 points is defined as continent, able to eat and dress independently, able to walk at least a block, and able to go up and down stairs.
Berg Balance Scale (BBS)	through study completion, an average of one month	Balance ability will be tested using the Berg Balance Scale (BBS), which includes 14 functional balance items, with scores ranging from 0 to 56 points; better balance is indicated by a higher score.

Trial Locations

Locations (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey