Comparison of Effects of Interactive Video Games in the E... | NCT03175588

Studies
Comparison of Effects of Interactive Video Games in the Elderly

NCT03175588

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Feb 26, 2019Actual

Enrollment

58Actual

Phase

Not Applicable

Conditions

Virtual Rehabilitation

Interventions

Virtual Rehabilitation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2017Actual

Primary Completion Date

Mar 11, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Jun 1, 2017

First Submission Date that Met QC Criteria

Jun 1, 2017

First Posted Date

Jun 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2019

Last Update Posted Date

Feb 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aynur CICEK, PT, MSc, Istanbul UniversityPrincipal Investigator

Lead Sponsor

Istanbul UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to assess the effectiveness of interactive video-games on mobility and wellbeing and to compare them with activity-based approaches in geriatric population.

100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
virtual rehabilitation	Experimental	video based exercise	Other: Virtual Rehabilitation
physical Activity	No Intervention	different type of physical Activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Rehabilitation	Other	Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation will be used	virtual rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Berg Balance Scale	Balance measurement	5 minute

Secondary Outcomes

Measure	Description	Time Frame
10-meter walking test	functional ability and balancing	3 minute
WHQOL-Bref	quality of life	15 minute

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mini mental test score abowe 21 age between 65 and 85

Exclusion Criteria:

neurological disorders orthopedical problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arzu Razak Ozdincler, Prof	Istanbul University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bahcelievler Community dwelling		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069350	Telerehabilitation

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided