NCT06128187

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 7, 2023

Last Update Submit

November 7, 2023

Conditions

STROKE REHABİLİTATİON

Keywords

Stroke, Rehabilitation, Virtual Reality, Upper Extremity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Fugl-Meyer Assessment (FMA-UL)

    18 weeks

  • Barthel index

    18 weeks

  • Stroke Specific Quality Of Life scale (SS-QOL)

    18 weeks

  • Montreal Cognitive Assessment (MoCA)

    18 weeks

  • stroop test

    18 weeks

  • +2 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants will undergo a conventional upper extremity rehabilitation program for 45 minutes daily, 5 days a week, for 6 weeks. After the conventional rehabilitation program, 30 minutes of virtual reality training for the upper extremity will be applied.

Other: Control Group

Study Group

ACTIVE COMPARATOR

Participants will undergo a conventional upper extremity rehabilitation program for 45 minutes a day, 5 days a week, for 6 weeks. In addition to the conventional rehabilitation program, dual-task training will be provided with a 30-minute virtual reality training program. Cognitive tasks will be given in addition to virtual reality training as dual-task training.

Other: Study Group

Interventions

Control GroupOTHER

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.

Control Group
Study GroupOTHER

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

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erenkoy physical therapy and rehabilitation hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Marmara üniversitesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ramazan öztürk

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

Ramazan ozturk

CONTACT

+90 539 950 8486fzt.ozturk@gmail.com

Ramazan ozturk

CONTACT

+90 539 950 8486fzt.ozturk@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were enrolled in treatment without being aware of differences in treatment between groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups. Study group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

November 15, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

TU(2)