Clinical trial NCT06128187: The Effect of Dual Task Training on Upper Extremity Functions in Stroke Patients
Official title: The Effect of Dual Task Training With Virtual Reality on Upper Extremity Functions and Cognitive Functions in Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: STROKE REHABİLİTATİON
Keywords: Stroke, Rehabilitation, Virtual Reality, Upper Extremity
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. Study group and control group
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Box and Block test (BTT)
timeFrame: 18 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA-UL)
timeFrame: 18 weeks
measure: Barthel index
timeFrame: 18 weeks
measure: Stroke Specific Quality Of Life scale (SS-QOL)
timeFrame: 18 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 18 weeks
measure: stroop test
timeFrame: 18 weeks
measure: Digit Span Test (DST)
timeFrame: 18 weeks
measure: oktem SBST
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Erenkoy physical therapy and rehabilitation hospital
city: Istanbul
country: Turkey
facility: Marmara üniversitesi
Study officials:
affiliation: Marmara University
name: Ramazan öztürk
role: STUDY_DIRECTOR
References: