NCT06778525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 22, 2026

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

January 11, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

RehabilitationStrokeExergamingUpper Extremity

Outcome Measures

Primary Outcomes (2)

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

    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.

    Baseline and 8 weeks

  • Frenchay Arm Test

    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.

    Baseline and 8 weeks

Secondary Outcomes (5)

  • Modified Ashworth Scale

    Baseline and 8 weeks

  • Brunnstrom Stages of Stroke Recovery

    Baseline and 8 weeks

  • Box and Block Test

    Baseline and 8 weeks

  • Functional Independence Measure

    Baseline and 8 weeks

  • Stroke Specific Quality of Life Scale

    Baseline and 8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

A one-hour exercise protocol will be administered in this group, consisting of 30 minutes of conventional exercises and 30 minutes of Smartpose exercises.

Other: ExerciseOther: SmartPose

Control

ACTIVE COMPARATOR

A one-hour conventional exercise program will be administered to this group.

Other: Exercise

Interventions

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

Also known as: Rehabilitation
ControlExperimental Group

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

Also known as: Exergame, Virtual Reality
Experimental Group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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°

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa, Faculty of Health Science

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

ExerciseRehabilitationExergaming

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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
Physiotherapist

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 16, 2025

Study Start

January 11, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

January 22, 2026

Record last verified: 2025-06

Locations