NCT03845855

Brief Summary

This study evaluates the effects of virtual reality treatment in addition to robotic gait therapy on dual task performance, balance and gait in chronic stroke patients. Half of participants will attend virtual reality treatment in addition to robotic gait therapy for 12 sessions, while the other half will attend only robotic gait therapy for 12 sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable stroke

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

February 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2019

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 14, 2019

Last Update Submit

February 26, 2024

Conditions

Keywords

virtual realitystrokedual task

Outcome Measures

Primary Outcomes (3)

  • 10 meter walk test

    The time is measured after 10 meter walk completed

    change from baseline time at the end of 6 week

  • 10 meter walk test with cognitive task

    The time is measured after 10 meter walk with a cognitive task completed

    change from baseline time at the end of 6 week

  • 10 meter walk test with motor task

    The time is measured after 10 meter walk with a motor task completed

    change from baseline time at the end of 6 week

Secondary Outcomes (6)

  • Mini Mental State Examination

    change from baseline score at the end of 6 week

  • Functional Ambulation Classification

    change from baseline score at the end of 6 week

  • Rivermead Mobility Index

    change from baseline score at the end of 6 week

  • Berg Balance Scale

    change from baseline score at the end of 6 week

  • Falls Efficacy Scale - International

    change from baseline score at the end of 6 week

  • +1 more secondary outcomes

Study Arms (2)

Virtual reality with robotic gait

EXPERIMENTAL

virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.

Other: virtual realityOther: robotic gait

Robotic gait therapy only

ACTIVE COMPARATOR

only robotic gait therapy 2 times for week by 6 weeks

Other: robotic gait

Interventions

Virtual reality with a game

Virtual reality with robotic gait

robotic gait therapy

Robotic gait therapy onlyVirtual reality with robotic gait

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the research
  • Stroke for the first time
  • To be able to walk independently before the disease
  • To score 3 or above in the functional ambulation classification
  • months after stroke diagnosis
  • Not having open wounds
  • Severity of spasticity of the lower extremities to be 3 and below according to the Modified Asworth Scale
  • To score 24 or more in the Mini Mental State Examination

You may not qualify if:

  • Acute internal problems, additional neurological diseases, or orthopedic problems that might limit walking
  • To have received botulinum toxin treatment during 6 months before treatment or during treatment
  • To have stroke on both sides
  • To have neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi

Nevşehir, Kozaklı, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Büşra Kayabınar, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 19, 2019

Study Start

February 20, 2019

Primary Completion

June 11, 2019

Study Completion

June 11, 2019

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations