## Protocol Section
### Identification Module
**NCT ID:** NCT06413732

**Brief Title:** The Effect of Dual Task Training in Patients With Stroke

**Official Title:** The Effect of Dual Task Training on Gait, Balance, and Quality of Life in Patients With Stroke

#### Organization Study ID Info
**ID:** Karabuk Physiotherapy
#### Organization
**Class:** OTHER
**Full Name:** Karabuk University
### Status Module
#### Completion Date
**Date:** 2024-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-05-31

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karabuk University

#### Responsible Party

**Investigator Affiliation:** Karabuk University

**Investigator Full Name:** Tarik Ozmen

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study was to investigate the effect of dual-task training on gait, balance, and quality of life in individuals with stroke. The study included 30 individuals aged 30-80 years with stroke. All participants were assessed using the 10-meter walk test (10MWT), 10MWT under dual-task interaction (DTI), timed up and go (TUG), 30-Second Chair-Stand Test (30s-CST), Berg Balance Scale (BBS), Short Form 36 (SF-36). Participants were randomized into two groups. Both groups received conventional physiotherapy for approximately 1 hour, five days a week. Group I also received dual-task training.

### Conditions Module

**Conditions:**

- Stroke

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The dual-task training program combined with conventional physiotherapy was applied to both groups for approximately 1 hour, 5 days a week.

**Intervention Names:**

- Other: Conventional physiotherapy

**Label:** Group I

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Only conventional physiotherapy was applied to both groups for approximately 1 hour, 5 days a week.

**Intervention Names:**

- Other: Conventional physiotherapy

**Label:** Group II

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group I

- Group II

**Description:** Conventional physiotherapy was applied for approximately 1 hour, 5 days a week.

**Name:** Conventional physiotherapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** It is a scale designed to evaluate balance and determine the risk of falling. It consists of 14 items based on performance of sitting, standing, and posture change. Scores can range from 0 to 56. The higher the score, the better the postural control.

**Measure:** Berg Balance Scale

**Time Frame:** Six weeks

**Description:** The participant was asked to get up from the chair he was sitting on, walk 3 meters at a safe and normal speed, and then turn back and sit on the chair again. The time was recorded by a stopwatch.

**Measure:** Timed Up and Go Test

**Time Frame:** Six weeks

**Description:** The 10-meter walk test (10MWT) is suggested for assessing gait in post-stroke rehabilitation. The participant was instructed to walk at comfortable walking speed a distance of 10 meters. The time was recorded in seconds with a stopwatch.

**Measure:** 10-meter walk test

**Time Frame:** Six weeks

**Description:** For this test, the participant was seated on a chair with a sitting height of 45-47 cm, with his arms on his chest, and was asked to stand up and sit down as many times as possible within 30 seconds. The score was recorded as zero if the participant could not get up from the chair without using their arms

**Measure:** 30-Second Chair-Stand Test

**Time Frame:** Six weeks

**Description:** The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health.

The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health.

The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health.

**Measure:** Short Form 36

**Time Frame:** Six weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Having a score of 24 or above on the Mini-Mental State Test,
* Being able to walk at least 10 meters without using a walking aid
* Having a total score of 5 on the motor and cognitive sections of the Functional Independence Scale.

Exclusion Criteria:

* Neurological and orthopedic problems that could affect motor performance and balance
* Communication problems
* Patients who had received Botulinum Toxin injection treatment in the last six months

**Maximum Age:** 80 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Karabuk

**Country:** Turkey

**Facility:** Tarik Ozmen

**Zip:** 78050

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-31
