NCT06413732

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 9, 2024

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Berg Balance Scale

    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.

    Six weeks

  • Timed Up and Go Test

    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.

    Six weeks

  • 10-meter walk test

    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.

    Six weeks

  • 30-Second Chair-Stand Test

    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

    Six weeks

  • Short Form 36

    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.

    Six weeks

Study Arms (2)

Group I

EXPERIMENTAL

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

Other: Conventional physiotherapy

Group II

OTHER

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

Other: Conventional physiotherapy

Interventions

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

Group IGroup II

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarik Ozmen

Karabük, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 14, 2024

Study Start

September 1, 2022

Primary Completion

May 31, 2023

Study Completion

January 31, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations