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Completed

NCT Number: NCT06778525

The Effect of Rehabilitative Games With SmartPose on Upper Extremity Recovery in Stroke Patients

The goal of this clinical trial is to investigate the effects of SmartPose games on upper extremity motor, functional, and sensory recovery in patients with stroke. The main question it aims to answer is:

* Does the use of rehabilitative games with the SmartPose application work to treat upper extremity motor, functional, and sensory recovery in stroke patients?

Researchers will compare the experimental group with the control group, which receives only conventional exercises with proven effectiveness, to determine whether SmartPose has an effect on upper extremity motor, functional, and sensory recovery in stroke patients.

The experimental group will receive 30 minutes of neuromuscular therapy and 30 minutes of SmartPose, 3 times a week for 8 weeks.

The control group will receive 60 minutes of neuromuscular therapy, 3 times a week for 8 weeks.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Faculty of Health Science

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mini Mental State Examination score ≥ 24
  • Age between 35 and 75 years
  • Medical condition sufficiently stable to allow participation in active rehabilitation
  • Brunnstrom Upper Extremity Stage ≥ 3
  • Minimum sixth week post-stroke
  • Ability to perform shoulder abduction and flexion against gravity with a minimum of 20°

Exclusion criteria

  • Presence of secondary impairments affecting upper extremity movement
  • Modified Ashworth Scale score of 4 or 5
  • Inability to maintain independent sitting balance
  • Visual impairment or loss that prevents the perception of visual materials

Treatment and study plan

Exercise

Other

Personalized neuromuscular exercises, according to the patient's specific needs.

Other names: Rehabilitation

SmartPose

Other

Virtual reality application containing rehabilitative games developed for individuals in need of exercise.

Other names: Exergame, Virtual Reality

Primary outcomes

  1. The Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Limb

    Time frame: Baseline and 8 weeks

    Fugl-Meyer is the first measure developed to quantitatively assess sensorimotor recovery after stroke. In our study, to evaluate total sensorimotor recovery, we used the motor function section of this assessment, which consists of 33 items and a total of 66 points, and the sections on sensation, passive joint movement, and joint pain, which have a total of 60 points. Higher scores reflect better motor function recovery.

  2. Frenchay Arm Test

    Time frame: Baseline and 8 weeks

    FAT assesses motor control and hand skills in patients with functional loss in the upper extremity following neurological impairment. The test consists of 5 items and takes a total of 3 minutes. Each item is scored as successful (1 point) or unsuccessful (0 points). It is evaluated on a total of 5 points. Higher scores reflect better motor control.

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: Baseline and 8 weeks

    MAS is a scale developed to assess muscle tone by determining the resistance exhibited against passive movement throughout the range of motion in the joint, and its validity has been proven in cases of stroke. The Modified Ashworth Scale (MAS) consists of six categories: 0, 1, 1+, 2, 3, and 4 (with the addition of 1+). Scoring is based on the resistance felt during passive movement of the joint, where 0 indicates no increase in muscle tone and 4 indicates a rigid joint. Lower scores reflect a lower degree of spasticity.

  2. Brunnstrom Stages of Stroke Recovery

    Time frame: Baseline and 8 weeks

    Brunnstrom is an approach that can be used both as a treatment approach and to assess body functions in cases of stroke. The Brunnstrom staging system has created a common language in the rehabilitation process. Higher stages indicate closer approximation to normal motor function.

  3. Box and Block Test

    Time frame: Baseline and 8 weeks

    BBT is a measure that evaluates manual dexterity based on performance. The patient was asked to move as many cubes as possible from the box in front of them to the other box next to them using the affected extremity for 60 seconds. A higher number of transferred cubes indicates better hand performance.

  4. Functional Independence Measure

    Time frame: Baseline and 8 weeks

    The FIM is used to assess patients' functional status and level of independence. The test consists of two sections; motor skills and cognitive skills. Scores range from 18, indicating complete dependence, to 126, indicating full independence.

  5. Stroke Specific Quality of Life Scale

    Time frame: Baseline and 8 weeks

    The Stroke-Specific Quality of Life Scale was developed to assess quality of life parameters in stroke patients. The scale consists of a total of 48 items and 8 subscales. The items of the Stroke-Specific Quality of Life Scale are rated on a 5-point scale ranging from 1 to 5. The response options are scored as '1 = strongly agree, 2 = partially agree, 3 = neutral, 4 = partially disagree, and 5 = strongly disagree.' For some items, the response options are scored as '1 = could not do at all, 2 = had great difficulty, 3 = had some difficulty, 4 = had little difficulty, and 5 = no difficulty.' Higher total scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Rehabilitative Games With SmartPose Practice on Upper Extremity Recovery in Ischemic Stroke Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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