The Effect of Dual Task Training on Upper Extremity Functions in Stroke Patients

STROKE REHABILITATION Clinical Trial

Official title:

The Effect of Dual Task Training With Virtual Reality on Upper Extremity Functions and Cognitive Functions in Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06128187
• Other study ID #: 2023/06-69
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Mus Alparlan University
• Contact: Ramazan ozturk
• Phone: +90 539 950 8486
• Email: fzt.ozturk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients. Our aim is to determine the effectiveness of dual-task upper extremity training compared to single-task training.

Description:

Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients.

Materials and Methods: The study was planned on patients who applied to Erenkoy Physical Therapy and Rehabilitation Hospital and were diagnosed with hemiplegia by a specialist neurologist. Participants who met the inclusion criteria in the study will be divided into two groups as Group 1 = study group and group = 2 control groups by computerized randomization method. For the evaluation of upper extremity functions of the participants whose socio-demographic characteristics were recorded; Fugl Mayer Upper Extremity Assessment Scale, Box and Blocks Test (BBT), Stroop Test and Montreal Cognitive Assessment Scale (MOCA) will be used to evaluate cognitive functions. The Barthel index of daily living activities of the patients and the Stroke-Specific Quality of Life Assessment Scale will be used to evaluate the health-related quality of life. Evaluation of double-task performance will be evaluated by the Box and Blocks Test (BBT) and a cognitive task added to the Xbox 360 Kinect game apps. Participants will be evaluated 4 times before the treatment, after the treatment and at the 1st month and 3rd month after the treatment in order to see the sustainability of the effect of the rehabilitation program.

Patients in both groups will receive a conventional upper extremity rehabilitation program (neurophysiological methods, joint range of motion exercises, strengthening exercises, occupational therapy) and 30 minutes of virtual reality training for 6 weeks, 5 days a week, for 45 minutes daily. Participants in the study group will be given double-task training in addition to stroke rehabilitation and virtual reality training. Dual task training will be performed with the addition of cognitive tasks in addition to virtual reality training.

Cognitive Tasks;

1. Attention-oriented, e.g. Counting numbers: Counting numbers backwards three by three from the participant rhythmically,

2. For memory, e.g. describing activities of daily living: Describing an event from the participant in detail,

3. For executive functions, e.g. Verbal communication: It will be planned in the form of giving the participant a letter from the alphabet and asking for words in certain categories such as plants, animals and countries. As progress is made, the difficulty of the missions will increase.

Xbox 360 Kinect game console will be used for virtual reality treatment. In the treatment, a rehabilitation program will be prepared with games that require complex upper extremity movements such as tennis, golf, darts and boxing to improve upper extremity functions.

We think that dual-task training will increase upper extremity functions and cognitive functions. Due to the lack of dual-task training studies with the upper extremity, we think that our study will contribute to upper extremity rehabilitation protocols and dual-task training literature.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are diagnosed with hemiplegia for the first time

• Patients aged =18 years

• Medically stable

• According to Brunnstrom stages, the upper extremity is at stage 3 and above

• Must have the ability to understand, hear and speak sufficiently to perform treatment with a game console.

• Montreal Cognitive Assessment (MoCA) score = 21

• Patients who are literate

Exclusion Criteria:

• Presence of high blood pressure, heart disease, vision problems

• Those with risk of shoulder subluxation and fracture

• Hemiplegic side, with joint movement limitation in the upper extremity Having a history of epileptic seizures

Related Conditions & MeSH terms

• Stroke
• STROKE REHABILITATION

Intervention

Other:
• Control Group
Participants will receive treatment 5 days a week, 45 minutes a day for 6 weeks. After the traditional rehabilitation program, 30 minutes of virtual reality training will be given.
• Study Group
Participants will receive treatment 5 days a week, 45 minutes a day for 6 weeks. After the traditional rehabilitation program, 30 minutes of dual-task training will be given

Locations

Country	Name	City	State
Turkey	Erenkoy physical therapy and rehabilitation hospital	Istanbul
Turkey	Marmara üniversitesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Mus Alparlan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Block test (BTT)	Box and Block test (BBT) was used to measure unilateral gross manual dexterity. This test consists of moving, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60seconds. The patients had number of blocks moved within 60seconds was recorded. The higher number of blocks moved, the higher score you get.	18 weeks
Secondary	Fugl-Meyer Assessment (FMA-UL)	The upper limb score in the Fugl-Meyer Assessment (FMA-UL) was used for primary outcome measure to assess the motor function of both upper extremities in- cluding the shoulder, elbow, forearm, wrist, and hand. The FMA-UL is widely used for comprehensive clinical examination of arm function, and the maximal score of FMA-UL is 66 points	18 weeks
Secondary	Barthel index	The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.	18 weeks
Secondary	Stroke Specific Quality Of Life scale (SS-QOL)	The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.	18 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	The MoCA test is a simple, in-office tool that can quickly determine if there is any impairment in a person's cognitive function, including their ability to understand, reason, and remember. The MoCA test is based on scores with a maximum score of 30. The MoCA test examines seven domains (aspects) of cognitive function with a total of 11 different exercises and tasks.	18 weeks
Secondary	stroop test	The Stroop test will used to measure cognitive function in the present study. This test simultaneously reflects reaction time (speed aspect) and accuracy. Here, the effect of different performance levels among the subjects was minimized by specifying the reaction time as the number of items performed within a given time. In addition, accuracy will measured using the number of errors made.	18 weeks
Secondary	Digit Span Test (DST)	Digit Span Test (DST) is a widely-used neuropsychological test in the assessment of attention and working memory, which consists two sections, forward and backward span.	18 weeks
Secondary	oktem SBST	Oktem (SBST) Test is a test that analyzes verbal learning and memory capacity. Information is collected about the participant's instant memory and ability to sustain attention.	18 weeks